Job Search

498 RESULTS

Date Job Title Job Level Location
11/20/19 Biophysical Associate Scientist/ Scientist, Small Molecule (Biochemical & Cellular Pharmacology) Individual contributor South San Francisco, California

Genentech Research and Early Development (gRED) is seeking a talented Associate Scientist / Scientist to join the Biochemical and Cellular Pharmacology Department supporting small molecule drug discovery. The successful candidate will have opportunities to drive innovation in assay development principally using surface plasmon resonance and other biophysical techniques to meet project deliverables. 

 

In hiring new employees, we look for people who are inspired by our mission and thrive in our collaborative and scientifically rigorous culture. In addition to supporting cross-disciplinary small molecule project teams, there will be ample opportunity for leadership roles. We will support development opportunities for leadership as needed as the employee matures in the position.

 

Who You Are

The candidate must have a PhD, or equivalent, in biophysics or associated discipline applicable to drug discovery, ideally with some relevant experience beyond PhD.  Experience in the application of surface plasmon resonance, or equivalent label-free technology, is desirable but not essential. 

 

While technical skills and techniques are important, we place higher value in critical thinking, scientific acumen and a collaborative style as these qualities are essential to success in a rapidly evolving drug discovery environment. Candidates with large molecule drug discovery experience will also be considered. A broad understanding of early drug discovery while desirable is not a requirement as we will work to provide suitable training and mentoring from world class scientists as needed.

#LI-GREDES1

11/15/19 Intern - Personalized Healthcare Data Science - Product Development South San Francisco, California

Length: 6 months

Target Start Date: 2/3/2020

Responsibilities:

The intern will focus on applying natural language processing and machine learning on large amounts of unstructured medical note data for the purpose of automated data point extraction. Preferred experience: natural language processing (including but not limited to deep learning, text data processing, entity extraction, coreference resolution in the biomedical domain, etc.), hands-on experience with TensorFlow (optionally PyTorch), and familiarity with oncology and medical terminology.

  • Construct NLP models, leveraging a range of approaches including statistical methods to deep learning models
  • Prepare and maintain pipelines for Named Entity Recognition, Named Entity Resolution and Relation Extraction in a medical domain
  • Assess and improve the quality of models and algorithms
  • Proactively share learnings and knowledge to support the development of these capabilities in the broader team

Requirements:

  • Understanding of NLP techniques for text representation, semantic modeling, databases/data structures, and machine learning and statistical modeling
  • Proficiency in Python (optionally pytorch), TensorFlow; keen ability to quickly translate ideas into code
  • Understanding of text processing and feature extraction techniques, such as tokenization, POS tagging, and dependency parsing
  • Knowledge of deep learning architectures frequently used for NLP applications (e.g. recurrent networks, attention-based architectures, etc)
  • Strong written communication and presentation skills with a high degree of comfort speaking both internally and externally
  • Familiarity with version-control tools (e.g, Git, BitBucket, etc)
11/15/19 Associate Scientist, Oncology Biomarker Development (OBD) Individual contributor South San Francisco, California

http://https://docs.google.com/document/d/1yAi-ELrjPd2GCkymPkIGgJcF5tsizUInvxGjcrytuIQ/edit

The Position

Associate Scientist (Development) for reverse translational studies

The Department of Oncology Biomarker Development (OBD) is seeking a highly talented and driven Associate Scientist (Development) to contribute to Cancer Immunotherapy (CIT) drug development and reverse translation efforts. Specifically, this individual will utilize preclinical data to design and validate biomarker strategies for early stage molecules and will use biomarker data from associated clinical trials to experimentally inform a deeper understanding of resistant mechanisms. The successful candidate is expected to have balance of strong bioinformatics skills for analyzing large clinical trial data sets and experience in human immunology and/or cancer immunotherapy.

The candidate will be part of a multifunctional team, including discovery scientists, bioinformatics scientists, and clinical researchers. The Associate Scientist has the opportunity to be mentored and grow over time into an externally recognized leader in translational science with a strong influence in the field of personalized cancer immunotherapy.

Responsibilities:

  • Aid in the generation and analysis of large-scale, genomic, phenotypic, and molecular data from internal and external sources.
  • Design, conduct, and analyze laboratory experiments in the areas of cancer

immunotherapy.

  • Collaborate with scientists across different departments at Genentech to accomplish research goals.
  • Participate in and contribute to team meetings by presenting experimental plans and results.
  • Strive to publish scientific and methodological results in high quality journals.

Job Requirement:

  • Ph.D. in immunology with 2-4 years of postdoctoral experience.
  • Proficiency in programming using scripting languages (Perl/Python), R, and experience in standard bioinformatics toolkits and programs.
  • Proficiency in analyzing bulk RNAseq, single-cell RNAseq, whole exome sequencing etc.
  • Demonstrated accomplishments with publications in the field of cancer immunology/tumor immunology with bioinformatics and wet lab skills.
  • First author publications in press or accepted in a top tier journal is a plus.
  • Effective oral and written communicator of ideas, project goals, and results.
  • Experience in human immunology, cancer immunotherapy, or translational research and ability to perform high quality functional assays.

What to expect from us:

  • A highly functional and collaborative research environment where we aim to translate our understanding of cancer biology to develop personalized therapies and diagnostics to transform clinical practice to benefit patient health.
  • Access to clinical data sets and samples.
  • Access to state-of-the-art technologies and pioneering research.
  • Participation in seminar series featuring academic and industry scientists.
  • Campus-like life style with a healthy work-life balance.
  • Mentored opportunities to further develop professional skills.

Who we are:

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national

origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

11/15/19 Senior Strategic Outsourcing Coordinator Individual contributor South San Francisco, California

The Senior Strategic Outsourcing Coordinator serves as the business interface between Safety Assessment and PTPK and nonclinical Contract Research Organization (CRO) vendors to ensure placement of in vivo and in vitro toxicological and pharmacokinetic studies for drug candidates from research through late drug development phases. The candidate will work in partnership internally with Toxicologists, Pathologists, Pharmacokinetic Scientists, Study Monitors, and Contracts personnel.

Responsibilities include but are not limited to:

  • Lead scientific, technical and business related risk assessments to assist with CRO selection for Safety Assessment and PTPK studies
  • Generate RFIs/RFPs, negotiate RFQs, analyze results of such proposals and present recommendations to senior management
  • Develop, manage and maintain relationships with CROs at the operational level (e.g. regular communications, issue management, organization of visits/meetings)
  • Lead nonclinical CRO business reviews/visits to ensure business continuity and contribute to the planning and execution of the safety assessment and PTPK outsourcing strategy
  • Understand CRO trends and any changes in CRO landscape including emerging innovative technologies and capabilities
  • Serve as the strategic outsourcing/business operations lead in cross-functional groups such as Expert Working Groups (EWGs) and CRO liaison groups
  • Provide business operations data summaries and statistics to support data-driven decisions
  • Manage internal study forecasting processes to mitigate lead time risks at CROs
  • Supports implementation of best practices and process improvement with internal stakeholders and external business partners to ensure high quality studies

Requirements:

  • BA or BS in biological sciences or related scientific field, or MBA with relevant work experience in the biopharmaceutical or CRO industry
  • Minimum 5 years of experience in comparable role, e.g. outsourcing, procurement, vendor relationship/account management or CRO business development
  • Experience working at or managing CROs and GLP knowledge/experience is a plus
  • Evidence of strong negotiation and interpersonal skills with the ability to develop close working relationships with internal stakeholders and CROs  
  • Demonstrated analytical ability and problem-solving skills, and excellent oral and written communication skills.
  • Ability to plan and organize effectively with a proven track record of independently managing multiple competing projects simultaneously
  • Must be detail oriented, with an ability to work both independently and in a team-based environment
  • Risk and financial analysis skills and the ability to interpret and utilize key metrics data
  • Availability for occasional travel both domestic and international

#LI-BJ1

11/15/19 Informatics Analyst II, Development Sciences Informatics Individual contributor South San Francisco, California

We are seeking a talented and experienced informatics analyst to contribute to and help lead data management efforts in Development Sciences Informatics (DevSci Informatics) through the development of new and/or improved data standards, models, terminologies, and ontologies. 

Who we are: 

Development Sciences (DevSci) is a translational science organization that plays a critical role both in Genentech Research and Early Development (gRED) and late stage development of products at Roche. DevSci supports drug discovery and development projects across all therapeutic areas from discovery to launch (and beyond). We are poised at a unique time when large volumes of complex and varied internal and external data for DevSci areas, such as Biomarker, PK/PD, Diagnostics, Safety Assessment, and Bio-analytical, need to be readily accessible to ensure that swift analysis, interpretation, and decision making can occur. These data impact decisions in ongoing pre-clinical and clinical programs, and provide key knowledge to inform new target discovery.

 

The DevSci Informatics (DSI) function is accountable for leading the strategy and execution around data lifecycle management, data standards, analytics infrastructure, ongoing data operations, and informatics systems. The data management team in DSI is focused on improving data quality and ensuring data are FAIR (Findable, Accessible, Interoperable and Reusable) through the development of new processes, standards, and solutions.

Major Responsibilities and Duties:

This role will be responsible for contributing to and helping drive data lifecycle management projects that enable the storage, organization, dissemination, and analytics of data in alignment with the scientific objectives of functional groups in the DevSci organization. A primary focus of this role will be in defining new processes, specifications, standards, models, terminologies, and ontologies for exploratory data generated in and used by DevSci.

In the process of performing this work, the candidate will collaborate extensively with scientists, research associates, operations managers, clinical data managers, data scientists/analysts, data curators, terminology experts, and vendor representatives. As well, this individual will take an active role in aligning data standards across DevSci with global efforts at Roche. This position may or may not have direct reports.

  • As a member of a diverse team of informatics professionals, lead planning and implementation efforts to provide informatics solutions for data management.

  • Ensure DevSci data is generated, received, cataloged, structured, and analyzed in a timely and efficient manner to meet the needs of data consumers.

  • In collaboration with terminology management and curation teams across Roche, support the definition of new data standards, data models, terminologies, and ontologies.

  • Help define and establish conformance checking processes at data acquisition that leverage new data standards, data models, terminologies, and ontologies.

  • Contribute to the establishment of cross-functional partnerships that ensure data accessibility, quality, integrity, and standards.

  • Participate in data governance initiatives across Roche that are aimed at the standardization of data based on defined models.

  • Ensure the delivery of relevant informatics solutions to meet functional and corporate goals. Communicate learnings and best practices across the organization.

  • Communicate strategies, ideas, goals, and progress to the data management group and the DevSci Informatics department.

  • Work extensively with DevSci scientists and biosample operations managers within DevSci, and collaborate frequently with clinical scientists, statisticians, data curators, terminology experts, and database specialists across the company.

Competences and Qualifications:

  • Bachelor’s degree with 5+ years relevant experience; or Master’s/PhD degree with 3+ years relevant experience; or equivalent experience. Degree in a scientific discipline preferred. Advanced degree a plus.

  • Thorough understanding of R&D processes and the scientific data lifecycle. Evidence of business and technology acumen. Experience with scientific data management tools and techniques, informatics systems, and managing scientific stakeholder relationships.

  • Background with complex biomedical/biomarker data (e.g. RNA-Seq, WES, Microarray, Flow Cytometry, Mass Spec, Immunoassay, Immunohistochemistry) a plus.

  • Knowledge of the UNIX operating system, and familiarity with a scripting language (e.g., Perl or Python) or a statistical programming environment (e.g., R or SAS) is a must.

  • Strong background in data standards, semantics, terminologies, ontologies, and best practices for data governance. Familiarity with the FAIR (Findable, Accessible, Interoperable, and Reusable) data guiding principles a major plus. 

  • Familiarity with Semantic Technologies or RDF vocabularies to describe terminological knowledge (such as SKOS, SKOS-XL, Dublin Core, RDFS) a plus.

  • Familiarity with public biomedical ontologies and standards consortiums (e.g. OBI, NCI, MedDRA, MeSH, LOINC, Uberon, RxNorm, CDISC, Allotrope, OHDSI, or FHIR) a plus.

  • Experience working with CROs and managing contract services is preferred.

  • Excellent people and communication skills.



#DevSci

#LI-BJ1

11/15/19 Scientific Researcher / Senior Scientific Researcher, Analytical Research Individual contributor South San Francisco, California

We are seeking a Scientific Researcher/Senior Scientific Researcher to support small molecule drug discovery at Genentech.  This person will join a high-energy team that is responsible for all aspects of purifying and analyzing small molecules, short peptides and macrocycles. Regularly employed techniques include HPLC, SFC, LCMS, and NMR.  The successful candidate will develop HPLC and SFC methods, perform sample preparation and analyze samples, summarize and interpret data, troubleshoot instruments and methods, interact with chemists to help support their projects and present findings at group meetings. The candidate will be expected to write scripts and programs to enable automation of sample handling, data analysis and data management workflows. Members of this team are expected to keep up to date with the latest methods and technologies. The successful candidate will accomplish our mission through innovation, teamwork, clear communication, creative problem-solving, and through the application of state-of-the-art technology including HPLC, LC-MS, SFC and a variety of automation equipment.

Who You Are

Candidates must have earned either a B.S./M.S. degree in Chemistry, or related fields, with at least 2 years experience in the pharmaceutical industry. Candidates must have good theoretical knowledge of analytical chemistry, hands on experience in chromatography (RP, NP, IEX, SEC) and other analytical techniques (MS, NMR). Candidates must also have experience in automation scripting/computer programming. Strong preference will be given to candidates with extensive purification experience, especially isolating macrocycles and short peptides.  The successful candidate will have excellent communication skills (verbal and written), interpersonal skills, and problem-solving skills.  Outstanding candidates with over 5 years of experience and strong publication record will be considered as a Senior Scientific Researcher.

#LI-GREDES1

11/15/19 QC Analyst Individual contributor South San Francisco, California



 

Job Description

The Senior QC Analyst will perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC operations.

Responsibilities

  • Perform a broad variety of basic and moderately complex tests with documentation according to GMP
  • Maintain accountability for deliverables affecting department and organizational objectives 
  • Accountable for exhibiting behaviors as described by Genentech/Roche Core Competencies. 
  • Maintain a state of inspection readiness 
  • Assure and apply GMP throughout operations
  • Identify gaps in systems and procedures 
  • Identify discrepancies and support resolution of technical problems
  • Assure and apply GMP throughout operations 
  • Supports department to meet corporate goals and department objectives 
  • Provide quality oversight support to internal/external customers 
  • Perform any other tasks as requested by Management to support Quality activities 
  • Actively participate in group and project teamwork
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.
  • Prepare and maintain reagents per established procedures

Lab Task Responsibilities

  • Perform routine and semi-routine assignments that are complex 
  • Schedule and perform routine and non-routine lab maintenance
  • Coordinate and perform scanning and archiving of cGMP documents
  • Coordinate and perform inspection of reserve and product/partner complaint samples
  • Prepare basic reagents as assigned
  • Order and maintain lab supply inventory
  • Verify, receive/pick up and deliver/store samples as assigned 
  • Aliquot samples as required, including aseptic aliquoting
  • Resolve sample issues as needed
  • Perform routine and non-routine sample handling, including labeling and packaging for shipment as assigned
  • Adhere to cGMP policies and procedures, including documentation of activities
  • Record information and complete transactions in applicable cGMP systems
  • Coordinate with customers to support operational activities
  • Frequent contacts with peer positions across the organization
  • Perform testing for equipment qualification/maintenance 
  • Reconcile and dispose of sample inventory
  • Review and propose changes to SOPs 

Qualifications

The successful candidate will possess the following skills and experience:

  • Bachelor's degree, preferably in a scientific discipline, or Associate's degree with 5 years of related experience
  • Demonstrated basic knowledge of scientific theories, principles and techniques used in analytical or biological test procedures
  • Experience working in a lab environment in an industry or academic setting is preferred
  • Ability communicate clearly and effectively, both verbally and in writing
  • Ability to exercise sound judgment, reasoning and problem solving capabilities
  • Attention to detail with strong organization and prioritization skills
  • Takes accountability and works effectively as part of a team
11/15/19 Regulatory Documentation Scientist South San Francisco, California

Position Purpose:

To prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety). The Regulatory Documentation Scientist takes accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. The Regulatory Documentation Scientist applies scientific writing, editing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management.

Major Responsibilities and Accountabilities:

  • Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate
  • Liaises with document contributors to gather information (including Licensing partners where relevant)
  • Plans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate.
  • Resolves issues, errors, or inconsistencies in data with contributors as appropriate
  • Reviews documents for: organization/clarity/grammar/scientific standards/internal consistency (e.g., between text and data displays).
  • Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments
  • Ensures that documents are published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory
  • Obtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documents
  • Participates as a member of key functional/cross functional Team (s) (e.g. Regulatory Affairs Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
  • Actively contributes to best practices and continuous improvement within Regulatory Documentation
  • Keeps informed on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas

Qualifications

Bachelor’s degree or equivalent.

Advanced degree in life sciences or other relevant field preferred.

Experience, Knowledge, Skills

  • Demonstrated clear, high-quality scientific writing style in the English language
  • Experience in regulatory affairs or related functions in drug development preferred
  • Ability to independently analyze and synthesize data from a broad range of disciplines
  • Project management skills: consistently achieves multiple tasks and goals on-time
  • Good interpersonal and verbal communication skills
  • Ability to work effectively in a team environment, establishes strong collaborative relationships

11/15/19 Manufacturing Technician - BioProcess Individual contributor Vacaville, California

Production Services:

Provide support to Manufacturing to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; Provide quality materials and service to our customers.

Responsibilities:

Technician

  • Follow established safety and environmental guidelines and procedures for all work performed.
  • Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
  • Fosters safe work practices
  • Operate systems that clean and sterilize tanks and filtration systems.
  • Prepare materials for the production process.
  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
  • Escalate process issues as necessary to ensure resolution of issue
  • Comply with cGMP, SOP and manufacturing documentation.
  • Use automation to perform production and equipment operations.
  • Provide support to Manufacturing to meet production demands.
  • Assemble and prepare equipment for production.
  • Communicate effectively and professionally work in a team environment.

Qualifications:

Education and Experience

  • AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering
  • Or combination of college coursework and related work experience
  • Or Biotech certificate from approved program

Knowledge, Skills, and Abilities:

  • Strong oral and written communication skills.
  • Familiarity of computer-based systems
  • Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
  • Ability to read and understand engineering documents is desirable
  • Experience in creation and revision of Standard Operating Procedures and experience working in a Biotech Manufacturing GMP environment.
  • Must be able work weekends, off-shifts, and overtime as required.
  • No make-up or jewelry can be worn when working in the clean room environment.
  • Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
  • Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.
  • Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
  • Handle and work with hazardous materials and chemicals per OSHA guidelines.
  • Usage of hearing protection and dust masks may be required.
  • Expected to be on feet standing or walking for up to 90% of shift.
  • Travel up to 30 flights of stairs each shift to maneuver within the facility.
  • Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
  • Lift up to 40lb loads multiple times per shift and carry up to 30 lbs. Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.
  • Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.
  • Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds.
  • In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License
11/15/19 Principal Data Management and Analytics Product Specialist - PHC Informatics Individual contributor South San Francisco, California

Principal Data Management and Analytics Product Specialist - PHC Informatics

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we’ve only scratched the surface. At Genentech and Roche we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort.  

The Data Management Product Specialist will work closely with key stakeholders in the PHC Center of Excellence on design and development of data management technology solutions including landing zone and data modelling. The goals is to design and build the PHC Global Data Management Platform for Roche/Genentech’s current and future PHC data management needs. The PHC Global Data Management Platform will manage large scale Global Scientific Datasets e.g. Omics, Imaging, Digital and EHR modalities. The Data Management Product Specialist provides the business stakeholders a window to key innovative technology trends and evolution of technology within the healthcare industry, which has the potential to accelerate the fulfilment of the strategic vision. Through use of dashboards and governance boards, provides continuing communication to the business an overview of the progress of current IT innovation(s).

We expect the Data Management Product and Analytics Specialist to be a passionate business and product advocate within IT, with proven analytical capabilities. The Data Management and Analytics Product Specialist must be an effective negotiator, Technology savvy leader and communicator in working with Roche/Genentech’s multiple business units as well as with internal IT cross-functional teams. The ideal candidate will be a self-starter with a passion for transforming healthcare, a high level of flexibility, commitment, and a sense of humor. The Principal Data Management Product Specialist will join our diverse community of smart, fun, wholehearted, and engaged informatics professionals from various functional areas. This person will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”

As Data Management and Analytics Product Specialist on the PHC Pharma IT/Technology team, you will:

  • Partner closely with key stakeholders from PHC Center of Excellence, Research and Early Development teams (REDs), Product Development (PD) and Commercial business groups, and corresponding Pharma IT Groups and Global Infrastructure and Solutions (GIS)
  • Influence leaders across Roche and communicate PHC data management architecture, detailed designs and impact. Develop and design detailed solution architecture including PoCs execution.
  • Ensures that the technology architecture, solution architecture and detailed designs remain current with the business goals, and directs the development of architecture activities and projects, while aligning with current and long-term business and technology goals.
  • Architect, design and automate large scale data ingestion containing Imaging, Digital, EMR/EHR and Omics from different sources around the globe.
  • Design and lead the implementation of data ingestion pipelines from multiple internal and external sources, landing zone, data curation, metadata tagging and data loads in public Cloud’s e.g. AWS, GCP and Azure.
  • Assist in the development of a big data platform in Hadoop using pipeline technologies such as Spark, Oozie, and more to support a variety of requirements and applications 
  • Highlights short-term trade-offs vs long-term commitments and where those are worth implementing or not. Ensures that the Solutions are scalable (technology), efficient (process), effective (cost), and supportable
  • Mentor technical leads/software engineers to enable the individuals and the organization to develop a scalable and stable solution landscape
  • Have a broad knowledge and leverage the technical capabilities of the internal teams and external technology providers and vendors.
  • Conduct market assessments and to identify new capabilities for existing and future business needs.
  • Collaborate with other Strategy and Architecture groups across Roche 

Qualifications:

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have a Bachelor’s degree in Biology, Computer Science, Mathematics, Electrical Engineering, Information Systems or related field; Master/PHD in Business, Mathematics, Science, or Computer Science preferred. You bring overall 10+ years experience in data management, solutions design and/or architecture, of which at least 5-10 years as a Solution Architect with hand-on experience.

In addition, you bring the following skills and competencies:

  • Strong Experience in designing and implementing high available and highly scalable big data systems; 3+ years of experience in leading implementation of high scalable data management systems required
  • Proven Knowledge and Experience in designing, implementing Clinical Decision Support Systems, Digital Health/Sensor Applications, Patient Engagement Platform is preferred
  • Experience in designing and implementing multi-tenant cloud platforms that rely on large-scale datasets.
  • Partner with product and different PHC IT leads to understand business requirements, and design detailed solutions architecture that meet them.
  • Experience in database, application development, RESTful APIs, Agile development, Full-stack web development, creating and maintaining CI/CD pipelines.
  • Experience architecting, designing and implementing data warehouses on a terabyte/petabyte scale including massively parallel processing & columnar databases.
  • Hand-on experience with common JavaScript libraries, data visualization and data integration.
  • Hand-on experience in Architecting and designing Data Lake in AWS, with potential to grow across different cloud providers i.e. GCP and Azure
  • Deep hands-on experience with ingestion and processing of large Genomic, Digital, EMR, EHR, Omics, Imaging data sets coming from different data sources
  • Experience across multiple big data platforms, ETL, data modelling, and business intelligence big data architectures. Experience with the Hadoop ecosystem (Map Reduce, Spark, Oozie, Impala, HBase, etc.) and big data ecosystems (Kafka, Cassandra, etc.) with experience in at least one of the  SQL language.
  • Hands-on experience in designing and building data solutions in AWS, e.g. S3, EC2, Aurora, Glue, Lambda.
  • Strong Experience in HL7/FHIR data standards, HIPAA, PHI, ISO, GDPR and other global healthcare compliance/regulatory requirements.

11/15/19 Associate Director, HR Business Partner, Pharma Technical NA Executive (Director/VP) South San Francisco, California

SUMMARY:

The Associate Director, Human Resources is the HR business partner for the PT North America global leaders of PTR and leads an HR team of four human resources business partners. All of these functions represent global organizations with employees and leaders that span SSF,  Washington, DC, Basel, Switzerland, Penzberg, Germany and Mississauga, Canada, Asia and LATAM. 

This role is the strategic business partner to leaders and leadership teams within the client organizations. This position manages complex/matrix relationships on both a local and global level, collaborating effectively across business and HR networks/partners.  The person in this role will consult, advise, coach and partner with the business on people and organizational needs -- ensuring alignment with agreed functional and regional/site initiatives as well as business strategy. This role also partners with leaders to drive organizational effectiveness including change management. 

RESPONSIBILITIES:

● Act as key HR point of contact, trusted advisor, and sounding board for client Leadership Teams. Identify, define and implement solutions that address the needs of the business while taking into account the broader implications (e.g. PT Globally). 

● This role is a key partner to the PT Global HR leaders to ensure alignment and understanding of activities across PT. 

● Contribute to the business strategy. Drive the people agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & PT HR strategy and goals (i.e., actively sponsoring and leading goals at LT level). 

● Ensure excellent alignment and execution of established human resources policies, procedures for functional and site HR initiatives. 

● Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).

● Partner with Global/Regional/Local HRBPs to align and execute on initiatives and processes (this includes providing input to and leveraging tools and templates used across PT and CoEs where appropriate). Contribute to assessment/selection for senior leaders and other critical positions.

QUALIFICATIONS 

12 + years of progressively responsible HR and/or business experience with 3+ years of  leading teams

● Bachelor's Degree or equivalent work experience required. Possess a full range of functional Business Competencies – Strategic Workforce Planning, Analytics,  Business Acumen, Organizational Development, Talent Planning and Pipelining and Cultural Transformations

● Previous HR experience in a global organization and proven ability to interact at senior levels a plus  

● Bio-tech or pharmaceutical experience a plus

● Broad HR Functional/Technical Knowledge and Expertise 

● High Level Project Management Skills 

● Excellent Consultation and Influencing Skills 

● Demonstrated Leadership Skills

NOTE: This role is not eligible for relocation

11/15/19 Specialist (Mandarin Speaker) - HR Employee Lifecycle Management (HR Operations) Petaling Jaya, Selangor

Position summary

At Roche, we named our HR lifecycle support team “ELM”, which stands for Employee Lifecycle Management. 

The ELM team provides customer service and advisory support to HR and business partners on global HR systems and processes and ensuring end-to-end process completion in line with customer focused principles to ensure the Roche People Practices work for the business.

As an ELM Specialist, you are responsible for executing HR system data maintenance and administrative activities in a timely and accurate manner in support of HR business processes (in the area of recruiting, onboarding, employee movement/changes, terminations, compensation, performance, etc.).  You are also contributing to the continuous improvement of the HR Support Solutions delivery through analysis of the interactions and collaboration with other HR functions within and outside of HR Support Solutions. You need a broad understanding across global HR processes and tools, as well as local and global downstream impacts on payroll, time, benefits, finance, procurement, IT, etc. This is coupled with strong customer focus, communication skills and solution orientation.

Responsibilities

  • Service Delivery

    • Execute system data maintenance and administrative activities in support of HR business processes (e.g. Attract To Onboard, Redeploy To Retire, Assess To Reward)

    • Provide customer service on HR related activities, such as inquiry resolution, request management, and troubleshooting.

    • Supports Global HR Centers of Excellence in system maintenance activities.

    • Advise HR and business partners on global HR systems and processes, and support the embedding of the new ways of working.

    • Actively participate in the development and implementation of continuous improvement initiatives.

    • Provide guidance and advisory to first level support teams.

    • Be up to date on processes, own the knowledge development on processes, and contribute to the update of relevant documentations (SWIs, SOP, GWIs).

    • Update SWIs and local SOP documentation

    • Participating in project activities as required

    • Display high integrity on the job and comply with the Roche guidelines, including data privacy rules and regulations.

    • Ensure consistent and reliable service delivery for customers serviced.

    • Implement processes and initiatives to ensure continuous improvement as well as service enhancement.

    • Align service delivery and quality with overarching objectives of the global HR Support Solutions organization. Manage service quality expectations and address customer concerns

    • Ensure end to end ownership of resolution

    • Ensure operations according to defined KPIs and SLAs.

    • Ensure regulatory compliance in line with the countries, customers, and regulations.

    • Develop and manage key stakeholder relationships and communications to partner in a proactive and customer outcomes focused way.

  • Cross-Functional Collaboration

    •  Build relationships with HR colleagues within the HR Support Solutions organization as well as with customers to ensure ongoing service delivery effectiveness.

    • Collaborate with peers within region and globally to ensure the HR Support Solutions network provides consistent and effective services to our customers.

    • Achieve our HR Support Solutions vision by driving global consistency through collaboration. 

  • Outputs & Deliverables

    • Continuous contribution to the improvement of the performance of the Shared Service Centre 

    • Reaching high customer satisfaction through consistent, high quality delivery and application of customer care principles (measured by defined stakeholder feedback)

    • Provide feedback, coaching and advice for contacts in both HR and the business (measured by defined stakeholder feedback)



 

Who you are

In this role you will be working within a team of Specialists focusing on Roche China customer group.

  • You bring the following skills and competencies:

    • Experience in a shared service center, preferably in an HR services environment. 

    • HR generalist know-how.

    • Proven track record of being able to deliver in a matrix organization.

    • Ability to work independently in a fast-paced environment and to handle multiple, competing priorities.

    • Ability to thrive in an ambiguous and multicultural environment working across borders. 

    • Experience effectively working in a matrix organisation across geographies and divisions. 

    • Ability to navigate complex HR data structure

    • Ability to work in a fast-paced and changing environment

  • Core capabilities include:

    • Living customer centricity through your day-to-day interactions (incl. needs anticipation, cultural awareness, managing one’s response)

    • Demonstrating end-to-end accountability (incl. big picture and impact understanding, engaging others to ensure a successful outcome) 

    • Demonstrating problem-solving (incl. active listening, critical thinking, process improvements)

    • Having a growth mindset (incl. taking risks and experimenting, seeking new learning opportunities, asking and giving feedback)

  • Further requirements

    • We are seeking an individual with a degree and 1-3 years of related experience in an HR area and/or working experience in a team and service delivery or customer care environment. 

    • Experienced and efficient handling of standard IT-applications, preferably Google suite

    • Knowledge of Workday HR Processes

    • You bring the following qualifications: University degree, HR preferred 

    • Strong communication skills in Mandarin and English (written and spoken) are essential. Additional languages a plus.

11/15/19 Principal HPC Integration Engineer Individual contributor South San Francisco, California

As a core member of the Roche Science Infrastructure (RSI) team, the HPC Integration Engineer will be responsible for the end-to-end shared HPC solution and its ability to be effectively used to support scientific and end user services.  Building relationships and working closely with developers and operators of external services as well as members of the RSI team, Enterprise Operations and Engineering groups, the successful candidate will rely on their experience, knowledge and expertise to support, enhance and optimize the use of shared HPC by the scientific computing community globally at Roche. The successful candidate will be responsible for defining the strategy for how enhanced services that utilize HPC resources interact, providing and end-to-end solution, participating and contributing to the broader scientific community.  The HPC Integration Engineer will also be responsible for contributing to the development of the overall elastic compute strategy, integrating new capabilities into HPC. Recognized as an expert in the field, they will provide technical consultancy to other members of Infrastructure Services, with demonstrated complex problem solving abilities. Some experience in mentoring and leading others in small team environments is highly desirable. The position is global and may be placed in one of several geographic locations, with South San Francisco highly preferred, followed by Kaiseraugst, Switzerland.

 

Main responsibilities:

  • Collaborating with various scientific computing communities assisting in the adoption and utilization of a globally distributed and accessible hybrid HPC.

  • Building a competency for the new Elastic Compute capabilities and services.

  • Providing consulting, guidance and best practices for utilizing advanced scheduling and hybrid computing for scientific computing with Elastic Compute Services.

  • Working with Service Reliability Engineers (SRE’s) to enable continuous enhancement and deployment maintaining stability & compatibility with scientific computing services and solutions, monitoring & metrics/KPI collection.

  • Working with (job scheduler, Linux, storage) RSI Service owners to support the technical needs of scientific computing groups.

  • Working with key stakeholders in assisting with the integration of scientific solutions that utilize HPC services.

  • Working with both RSI Engineers and key stakeholders,  develop standards and processes for build, test, deployment and lifecycle processes of scientific applications.

 

Qualifications:

 

The principal HPC Integration Engineer will be an experienced IT or Science professional. With a Bachelor’s degree (advanced degree preferred) in a relevant field of technology, science or business, possessing the following qualifications:

  • 5-10 years of experience as a High-Performance Computing consumer/developer with extensive experience as part of or working with scientific computing groups working across multiple disciplines.

  • In-depth knowledge of HPC environments and the various ways it can be used to support larger scientific computing ecosystems. 

  • Familiarity with hybrid computing and how to leverage scalable computing through job scheduling API's.

  • Knowledge of configuration management tools, CI/CD testing & delivery and tool chains (e.g., Ansible, Jenkins).

  • Familiarity with web services and kubernetes and how they can be integrated or leverage HPC services and environments.

  • Experience with scientific workloads and workload profiling and optimizing.

  • Familiarity and hands on experience in using HPC Job Schedulers and parallel file systems.

  • Working knowledge of scripting and programming languages such as C, C++, Fortran, Bash, CSH, TSCH, Perl, Python.

  • Good organization skills to balance and prioritize work, and ability to multitask.

  • Good communication skills to communicate with support personnel, customers, and managers.

#LI-CGPK1

11/14/19 Global Development Leader, Tecentriq Lung Manager with direct reports South San Francisco, California

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase IB – III) clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients. The PD International Development Leader (GDL) is a core member of the Lifecycle Team (LCT) and is responsible for overseeing and developing global Clinical Development (CD) molecule and disease strategies and ensuring effective and efficient execution for one or more molecules/indications/programs. PD GDLs guide the development of molecules and programs, approve Clinical Development Plans (CDPs) and priorities, and lead the design and final interpretation and completion of clinical studies. PD GDLs are members of the PD Clinical Science organization, have a scientific (M.D. or other advanced degree) background, and can manage a team of PDC Medical Directors and Clinical Scientists. PD GDLs interact with the highest levels of management and serve as scientific, medical, product development, and strategic experts both internally and externally.  The GDLs serve as internal consultants for Roche committees as well as represent the therapeutic area’s CD strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders worldwide. PD GDLs are expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic/disease area(s), including therapeutic area scientific strategies and plans, including acting as a key collaborative partner with gRED, pRED, Chugai, and partner companies. The TA and Franchise Heads may delegate approval of protocols, ICFs, IBs, and PBRERs to the GDLs depending upon the GDL’s level of scientific and technical expertise.

This GDL will lead clinical development of Tecentriq across lung and head & neck cancer indications. They will be a core member of the Tecentriq Lung LCT which resides within the LASR franchise.

PRIMARY DUTIES AND RESPONSIBILITIES:

Cross-Functional Team Leadership

  • A key member of the Tecentriq Lung Lifecycle Team’s Triad (GDL, LCL and IBL), representing Product Development (PD) 
  • Leads cross-functional, fit-for-purpose team(s) with a focus on product development, molecule or disease strategy
  • Represents PD/CD for assigned portfolio at the highest management/expert levels inside and outside Roche; includes championing and sponsoring the work of his/her staff
  • Represents PD/CD on cross-functional strategic workstreams and initiatives as well as with internal (REDs, PD functions) and external (Business Development, Partnering, Scientific and Medical Societies, Therapeutic Area Experts, Regulatory Authorities) interactions
  • Oversees one or more Clinical Development Plans (CDPs), disease strategies, molecules and/or indications, as well as associated clinical trial programs and studies. Guides direct reports to ensure cross-functional integration, coordination, and alignment to enable effective and efficient CDP execution
  • As member of the Tecentriq Lung LCT Triad, provides input and leadership regarding key decisions for molecules, Disease Areas, and Therapeutic Areas, including decisions regarding prioritization of activities.
  • Ensures direct reports and their staff are actively and appropriately aligning with sub-teams (e.g., Study Management Teams), to ensure on-time and on-target results
  • As needed, provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources

Staff Leadership & Development

  • Works with manager and peers to identify and ensure the appropriate infrastructure – clear roles and responsibilities, learning and development, technology, other tools, vendor partners and operating budgets
  • Where applicable, may participate in the negotiation with and commissioning of external vendor partners to support certain elements of the therapeutic area’s CD function
  • Assigns direct reports their projects and programs and guides direct reports in their assignment of projects and programs across their staff
  • Cascades strategic and other relevant goals and objectives as well as expense budgets to direct reports
  • Leads recruitment, hiring and training for his/her staff member roles
  • Provides direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins, and 1:1 meetings
  • Oversees staff members’ work to ensure on-time, on-target and within-budget results
  • Plays a leadership role in all formal and informal performance management and career development activities for his/her staff members
  • Actively participates in leadership and skill development programs for continued professional development
  • Initiates and develops cross-functional projects, programs or other initiatives that can carry broad and important impact to multiple Product Development objectives and activities
  • Consistently complies with all governing employment laws, regulations and company HR policies & procedures and ensures the same across his/her staff

Global Clinical Development Leadership

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).  Ensures the same across his/her staff
  • Provides CD leadership guidance and direction regarding competitive intelligence and/or other market/industry assessment activities and projects
  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Ensures the same across his/her staff
  • Educates others internally and externally on relevant clinical developments as these may implicate the assigned therapeutic area’s CD strategies, plans and programs
  • Collaborates with a variety of internal and external partners and stakeholders, such as HAs, clinical investigators, clinicians, scientists and key opinion leaders (KOLs). Has extensive interactions with these external parties, subject matter experts and influencers. Supports his/her direct reports and/or other CD staff members in their communications and interactions with these external parties
  • Works across Roche at all levels and with various groups and functions, such as other groups in PD, research, business development, manufacturing, commercial operations, legal, etc.; providing ongoing leadership expertise and guidance on the assigned therapeutic area’s clinical strategy
  • Plays a leadership role in providing clinical science input into the relevant therapeutic area clinical scientific strategy, as well as into relevant cross-functional and enterprise-wide plans, strategies and initiatives. Helps Research and PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals. As appropriate/needed, performs or delegates clinical assessments on relevant drug discovery projects
  • As needed, ensures his/her staff members support internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. Expected to provide expert leadership CD guidance, when needed, on Phase IIIB and Medical Affairs protocols
  • Consults to, and/or assigns staff members to consult to, pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s). Serves on joint executive committees, which include other Roche functions as well as external partner personnel, and/or assigns such responsibilities to direct reports
  • Leads global CD strategy development for the assigned portfolio. Acts as a regular reviewer/presenter to various internal committees
  • Acts as an expert advisor and consultant to various internal committees, other Roche management and teams regarding CD strategies, priorities, implementation and the like. Leads interactions with internal and external fit-for-purpose Advisory Forums and groups, in close collaboration with other Tiragolumab LCT Triad members.
  • Leads global development of clinical science input into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP).  Acts as an expert advisor to others regarding CD strategic alignment with and implications for LCPs for the assigned portfolio
  • Oversees creation and implementation of global CD plans for all molecule(s)/indication(s) and/or other programs across the assigned portfolio:
    • Accountable to ensure strategic and operational alignment of CD plans with the relevant CD strategy, Disease Area Strategy and LCPs
    • Guides CSTs in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
    • Reviews budget and other resource requirements necessary to implement and execute CD plans. Provides leadership guidance and direction to ensure the optimal use of resources
    • Supports direct reports, as needed, to ensure they gain alignment with various internal partners/stakeholders on goals and resource needs.  Includes guiding direct reports and other team leads
  • As needed, or otherwise appropriate, supports direct reports and/or other team members in their communications with HAs. Accountable to ensure his/her team members ethically, effectively and professionally represent the interests of Roche and patients. Accountable to ensure matters are escalated, when needed, in a timely manner to appropriate internal partners/stakeholders 

Global Clinical Plan Development Implementation

  • Accountable for the design, execution and medical/scientific data interpretation of global clinical studies and other evidence generation programs across the assigned portfolio:
    • Manages across multiple, often large-scale and highly complex projects
    • Provides guidance to direct reports in the strategy, design and implementation of clinical studies and other programs
    • Reviews various items and activities and provides leadership guidance and direction to ensure successful execution and completion of clinical studies and other programs: study protocols, incorporation of cross-functional strategies and input into programs, product safety profiles, etc. 
    • Oversees development of clinical sections of investigator brochures, other external presentations, information and materials
    • As needed, guides others in the identification and selection of appropriate external investigators and sites
    • Guides others in patient registry design and development (including strategies for patient registry recruitment)
    • Advises direct reports and others on development of study analytics and data management plans for their key, large-scale studies
    • Reviews and approves clinical components of presentations for clinical trial investigator and other relevant meetings
    • As needed, supports direct reports in conducting investigator or other external presentations, meetings and other communications
    • Provides ongoing guidance to direct reports, cross-functional teams, internal committees and company executives regarding the overall strategy, implementation and prioritization of CD activities across the assigned portfolio
    • Regularly reviews medical/safety data
    • Measures and monitors study progress against objectives and plans, including any variances. Proactively guides other team members on identifying, communicating and addressing any issues, challenges and potential strategies to resolve such
    • Reviews and approves various interim study reporting prior to further dissemination
    • Serves as a resource for issue management and resolution. Anticipates issues and helps prevent and/or resolve these
    • Oversees clinical study, database and study reporting completion. Approves final study reporting prior to further dissemination
    • Accountable to ensure correct medical/scientific data interpretation for interim and final study reporting
    • Guides direct reports in their assimilation and translation of safety and efficacy data for regulatory submissions
    • Oversees clinical science input for completion and submission of regulatory filings and other regulatory documentation. Advises direct reports and other team members in their development of clinical science information and input into regulatory submissions and other regulatory processes. Includes guiding others, as necessary, on development of labeling and packaging language, etc.
    • Keeps partners and stakeholders abreast of developments relative to the work of CD and the assigned portfolio and ensures same approach is consistently taken across his/her staff
    • As needed, advises direct reports and other team members regarding communications strategies to support existing and concluded studies. Includes interactions with Therapeutic Area Experts (TAEs), advisory boards (internal and external), Independent Data Monitoring Committees (iDMCs), Data Review Board (DRB), major medical meetings, congresses and other events, publications and other materials used to communicate Roche’s clinical view and position on clinical development plans and study results for molecules/indications across the assigned portfolio
  • Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities.  Includes regularly acting as an expert participant and contributor on advisory boards and other relevant external forums representing Roche
  • Drives and integrates ongoing evidence/data generation, including clinical trials, Medical Affairs studies, Real World Evidence (RWE), Patient-Centered Outcomes Research (PCOR) and other types of evidence. Plays a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs
  • Accountable to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target
  • Leads other special projects. Expected to proactively identify opportunities to continuously improve CD processes and operations and Roche’s leadership position in CD 
  • Consistently complies with, and ensures the same among relevant functional and cross-functional team members, all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

SELECTION CRITERIA:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

  • Board-certified M.D. with relevant medical experience in same/similar therapeutic area or advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) required
  • 10 or more years pharma/biotech industry experience OR is a recognized expert in the field.  A minimum of 4 years industry experience is preferred (exact number of years depending on level)
  • 4 or more years experience managing medical/clinical staff (exact number of years depending on level)
  • 8 or more years experience with clinical trials (exact number of years depending on level)
  • 2 or more years experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the U.S. (exact number of years depending on level)
  • 4 or more years experience authoring global clinical development plans (exact number of years depending on level)
  • 4 or more years experience publishing results of clinical drug trials in referred journals (exact number of years depending on level)
  • In-depth understanding of Phase I – IV drug development Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
  • Strong academic/teaching background is strongly preferred
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • In-depth understanding of competitive activity in the field
  • Current or past leadership roles in major scientific and advocacy organizations and standard-setting bodies is preferred

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values
  • Clinical leadership: is recognized as a subject matter expert in his/her field (includes external recognition as an expert); able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective); has made significant contributions to an organization’s drug development (whether for Roche or another organization); has identified and created clinical development strategies that have led to label-enabling product definitions
  • Has demonstrated outstanding leadership of multiple development projects and teams
  • Proven abilities to plan and resource multiple development projects on short-, medium- and longer-term bases
  • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
  • Strategic agility: has in-depth knowledge and broad experience in the pharma/biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
  • Considerable comfort around all levels of management; has regularly demonstrated the managerial courage necessary to succeed at higher-levels within the organization
  • Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
  • Strong influencing skills; proven abilities to get things done without formal authority 
  • Strong negotiation skills; is highly adept at identifying solutions that will meet the needs of all parties involved 
  • Strong communication & presentation skills; exhibits professional maturity, confidence and competence.  Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decisions
  • Strong conflict management skills; proactively minimizes situations where conflict may arise
  • Strong conflict resolution skills; proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties
  • Outstanding financial acumen: has a proven track record of achieving qualitative and quantitative results across multiple, often large-scale and complex clinical development projects
  • Ability to travel globally (<30%)
11/14/19 GLOBAL THERAPEUTIC AREA HEAD (MEDICAL) WITHIN ONCOLOGY/ HEMATOLOGY Global Product Development - Medical Affairs (PDMA) Basel, Basel-City

The global Medical working model for Oncology / Hematology comprises three dedicated Therapeutic Areas (TAs) – based on the three pillars of the global oncology / hematology strategy:

lung cancer, breast cancer and hematology. Other tumor types / indications and overarching frameworks (e.g. PHC, ImCORE) will be assigned to or across respective TAs based on optimal patient benefit / customer value

GENERAL ROLE CONTEXT

You will provide agile leadership, guidance, direction and framing as a visionary Architect, Coach and Catalyst. You will lead and empower teams and employees to achieve their objectives in a culture of curiosity, accountability, innovation and co creation. You will act as a key integrator, approaching work from an outcome rather than a functional perspective. You will display strong transformational and mobilizing leadership skills to inspire people to do their best work, constructively challenge the status quo and be committed to our cultural evolution.

And you will relentlessly focus on meaningful outcome for patients and societies, putting the patient first in everything you do.

As a Medical TA Head you will provide leadership, strategic guidance and holistic support to the personnel and medical teams within the respective therapeutic area. You will closely align and collaborate with other TA Heads in Global Product Strategy (GPS) and Clinical Development, Life Cycle Leaders and other stakeholders in a matrix organization, enabling the meaningful integration and delivery of the Medical strategy into the lifecycle and integrated strategy plans of your TA. You will provide strong clinical, scientific and healthcare ecosystem experience for key cross functional stakeholders. You will act as a key ambassador, connector and credible partner for the broad range of external medical partners, customers and stakeholders.

The roles report into the Head PD Medical Affairs.



SPECIFIC ROLE CONTEXT

As a TA Head (Medical) you will

 

  • Lead the creation and implementation of the long-term Medical vision and key objectives for the TA within the respective integrated Lifecycle strategies
  • Drive optimal resource use and outcome focused investment within and across therapeutic area medical teams, displaying an enterprise / LSPC (Late Stage Portfolio Committee) mindset
  • Be accountable for the development and successful delivery of the Medical contributions towards the lifecycle and integrated strategy plans, including
  • Situation analysis on TA level with a patient centric focus on Medical advancements and general healthcare ecosystem evolution
  • The holistic provision of an integrated evidence generation plan and oversight for the wider enterprise
  • Definition, prioritization and constant evolution of Medical objectives and Medical Value narrative on TA level
  • Identification and innovation of the respective tactical Medical activity portfolio
  • Contribute to establishing and implementing appropriate policies and standards for all activities of the integrated medical contribution (e.g. studies, publications, registries, TAE collaborations)
  • Ensure that planning and implementation of medical contribution are aligned with global processes and standards

What will set you up for success

  • You are a Medical Doctor with substantial clinical and scientific experience in the relevant therapeutic area, fully familiar with current clinical practice in the major global healthcare and regulatory systems and deeply engaged into the anticipation of the future evolution of Medicine
  • You bring significant leadership and business experience in the pharmaceutical or biotech industry, in a Development, Medical or strategic function at a country and a global or regional level
  • You have a proven track record of scientific/medical cooperation and network with key global therapeutic area experts and respective societies/collaborative groups
  • You have operated accountably and successfully in the space of next level data generation with a specific appreciation of clinical practice data, real world data and HTA enabling data
  • You have a strong track record of collaboration/ partnership with cross functional networks and teams, specifically Access, Development and Commercial, on country and global level
  • You are experienced and skilled with accountability for substantial budgets, embracing a mindset of meaningful enterprise investment versus a mindset of functional spend
  • You are an inspiring and visionary leader, living up to highest ethical standards, Roche Values, Leadership Commitments and Core Competencies
  • You excel in a matrix environment, are comfortable with complexity and ambiguity, and strive working across multiple cultures and countries with a focus on prioritization and outcome
  • You relentlessly simplify and accelerate work at any step towards greater value for patients and societies
  • You embrace curiosity, experimentation, learning and collaboration as essential elements of the work
  • You are inspired by and comfortably using the offerings of digital technology in the space of communication, analytics and services
  • You take pride in constantly identifying and recruiting external talent, growing yourself and people around you towards purposeful contribution

What your key outputs will be

  • Your key accountability is to enable the Medical teams to develop and deliver effective and meaningful, strategically aligned Medical contributions to the relevant Life Cycle Teams (LCTs)/ ISQUADs
  • You are accountable for development and delivery of the Medical strategies / contributions to the overall TA / Disease Area strategic plans
  • You ensure the availability and timely provision of holistic external Medical intelligence / insights within your TA for all key internal audiences
  • You compellingly and credibly communicate TA Medical content to in- and external audiences across the full range of communication channels and platforms
  • You act as external spokesperson on behalf of the enterprise within your TA and beyond as required
  • You represent the enterprise in respective external Medical / Academic communities for your TA and beyond where appropriate
  • You enable appropriate resource planning, ensuring that contributions take place as planned and with appropriate investment management towards optimal value for patients and societies
  • You drive the scouting and recruitment of in- and external talent and are accountable for people development, management as well as all other line manager responsibilities
  • You enable and implement new ways of working / agile methodology as seen fit for purpose
  • You engage actively in the constant evolution of the Global Medical function as well as the enterprise

Major technical role aspects / requirements

This is a global role based in Basel or San Francisco. A location at other Roche sites (Mississauga, Shanghai, Welwyn) can be considered. Intensive global travel is required. The role is in full adherence and actively advocates / contributes to internal policies, guidelines, and SOPs, as well as recognized GCP and ethical standards. Adherence to required training modules and responsibility for full training compliance of employees is expected.

The TA Head is contributing to the PDMA Leadership team, the Medical Affairs Council, Franchise Leadership Teams and other communities as seen purposeful and value adding. They chair the Medical Affairs Review Committee for the respective therapeutic area (unless delegated)

They represent PDMA at the Development Review Committee and the Business Review Committee (unless delegated)

When submitting your application please indicate the respective Therapeutic Area

(Lung Cancer, Breast Cancer, Hematology)

11/14/19 Senior Manufacturing Technician, Bioprocess Individual contributor Vacaville, California

This position is on the Night Shift. Wednesday to Friday, Alternating Saturday 1830-0730.

The Senior Manufacturing Technician, Bioprocess performs functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies and final assemblies. Uses sophisticated programs to collect and evaluate operating data to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process. Works with engineers in conducting experiments. 

The individual will be responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in current Good Manufacturing Practices (cGMP) environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing cGMP and Standard Operating Procedures (SOPs). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas: 

Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials. 

Downstream Manufacturing (DM): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials. 

Production Services (PS): Provide support to Manufacturing to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; provide quality materials and service to our customers. 

  • Follow established safety and environmental guidelines and procedures for all work performed 
  • Immediately reports safety and environmental incidents, including injuries, illnesses, near misses, and safety suggestions 
  • Fosters safe work practices 
  • Operate systems that clean and sterilize tanks and filtration systems 
  • Prepare materials for the production process 
  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading) 
  • Escalate process issues as necessary to ensure resolution of issue 
  • Comply with cGMP, SOP and manufacturing documentation 
  • Use automation to perform production and equipment operations 
  • Provide support to Manufacturing to meet production demands 
  • Assemble and prepare equipment for production 
  • Communicate effectively and professionally work in a team environment 

Requirements

  • High School Diploma and 5+ years related experience, or AA degree and 1+ year related experience, or Bachelors in Biological Sciences, Physical Sciences, or Engineering or 
  • Combination of college coursework and related work experience or 
  • Biotech certificate from approved program preferred

Knowledge, Skills, and Abilities 

  • Strong oral and written communication skills 
  • Familiarity of computer-based systems 
  • Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job 
  • Ability to read and understand engineering documents is desirable 
  • Experience in creation and revision of SOPs and Manufacturing Formula is desirable 
  • Must be able to work weekends, off-shifts, and overtime as required 
  • No make-up or jewelry can be worn when working in the clean room environment 
  • Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems 
  • Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift 
  • Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift 
  • Handle and work with hazardous materials and chemicals per OSHA guidelines 
  • Usage of hearing protection and dust masks may be required 
  • Expected to be on feet standing or walking for up to 90% of shift 
  • Travel up to 30 flights of stairs each shift to maneuver within the facility 
  • Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems 
  • Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift. 
  • Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift. 
  • Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2). 
  • In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure 140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License 

Position is not eligible for relocation. Only local candidates will be considered.

11/14/19 Transactional Team Leader, Associate Director/Assistant General Counsel, Corporate and Transactional Law Group Executive (Director/VP) South San Francisco, California

The Transactional Team Leader/Assistant General Counsel leads a transactional team within the Corporate and Transactional Law Group (“CTLG”), which is responsible for providing legal counseling to global Pharma Partnering and other transactional functions within Genentech.  

Responsibilities of the team leader include:

 Transactional Group and Personnel Management

  • Overseeing the quality of the legal services provided by the transactional team and helping ensure the consistency of legal advice related to transactions, including antitrust, privacy, and other matters relevant to transactions
  • Overseeing workload and resource allocation for the transactional team, and leading recruitment, hiring and on-boarding for direct report positions
  • Performance management and professional development of attorneys and staff in the practice group, and contributing to same for attorneys and staff across the CTLG
  • Managing outside counsel providing advice and deliverables to CTLG and, where applicable, negotiating rates, project fees, and timelines

CTLG and Legal Leadership

  • Serving as a standing member of the CTLG Leadership Team and contributing to CTLG-wide and Legal department projects and initiatives
  • Contributing to the development and implementation of the CTLG’s longer term strategies and annual goals
  • Contributing to the CTLG talent management and  succession planning
  • Cultivating a CTLG culture that reflects a strong commitment to employee engagement, diversity and inclusion

Leading more broadly in the Legal Department by proactively supporting other leaders, identifying and supporting opportunities to facilitate a “One Legal” mindset and approach to our work, and advancing Legal Department priorities

Business Support

  • Actively providing legal support to the global Partnering group and other transactional groups within Genentech, including drafting and negotiating agreements and supporting all aspects of interactions between the Roche Group and its contractual partners
  • Proactively identifying and managing legal issues, fostering strong relationships with client groups, creating efficient and effective processes for working with clients, advising and/or delegating authority to advise senior leaders in the Partnering and commercial organizations, and acting as a standing or ad hoc member of business or leadership teams
  • Participating in, leading, and/or presenting to various Company committees or other advisory, project or work teams 

 Required Skills and Experience:

  • Candidates must have a JD with appropriate state license OR registered in-house counsel
  • 10 or more years of relevant practice experience, and experience as a direct people manager or 3+ years of experience as a leader of a matrixed team or an effective mentor and coach of others.
  • Knowledge of and experience with US laws and regulations relating to transactional law, familiarity with global legal standards relevant to transactions in the biopharmaceutical industry
  • Experience drafting and negotiating complex transactions between biopharmaceutical companies
  • Ability to identify issues relevant to the biopharmaceutical industry, including antitrust, privacy, data security, Nagoya Protocol, pricing, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, and pricing and reimbursement.
  • The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers, as well as the ability to proactively identify and manage significant legal issues independently. 
  • Strong leadership, technical knowledge, business acumen, and excellent communication skills are required as is a track record of effective decision-making and the proven ability to assess, calibrate, and effectively communicate legal risk. 
  • You must have the managerial courage required to counsel senior leaders, lead a team of experienced attorneys, and effectively coach and mentor personnel, and demonstrate the organizational savvy and diplomatic sensitivities necessary to effectively collaborate with cross-functional client teams. 
  • You must also possess and consistently model a continuous learning mindset.

#LI-CGCY1

11/14/19 Senior II, SAP SRM Petaling Jaya, Selangor

Key competencies

  • Good background in IT service management such as ITIL.
  • Experience in applying IT service improvements methodologies like lean management, six sigma or others.
  • Ability to cooperate and communicate with people at different organization levels and within multidisciplinary teams.
  • Supplier performance management that includes KPI driven activities.
  • Knowledge on Project management (e.g. PMI, Prince2) and agile methodologies (like Scrum, Kanban, Lean) will have added advantage

Key responsibilities

  • Introduce and sustain the proactive approach that will lead to a reduced number of incidents and an increased system stability.
  • Sustain the timely delivery and estimation of new business requirement.
  • Provide functional and technical expertise for the business and IT stakeholders
  • Proactively identify incidents that are ‘candidates’ for being treated as PM with an objective of eliminating the root cause.
  • Analyzing problems for correct prioritization and classification
  • Coordinating actions of others as necessary to assist with analysis and resolution actions for problems and known errors
  • Monitoring progress on the resolution of known errors and advising incident management staff on the best available workaround for incidents
  • Assisting with the handling of major incidents and identifying their root causes
  • Manage Timely delivery of agreed enhancements.
  • Support/Assist the estimations and feasibility of business requirements by providing high level but accurate estimates
  • Close collaboration with other team leads in regards to resources assignment
  • Identify opportunities for continuous improvements through problem management, knowledge management etc.

Mandatory skills

  • 3-6 years of SAP SRM functional and configuration experience
  • Hands-on SRM & MM functional configuration skills
  • Experience in workflow configuration (application controlled and BRF process control
  • Optional: Experience in configuring UI5 add-on and FIORI
  • Expert in translating business requirements into functional design, collecting business
  • Experience in creating test scripts, test data, perform unit test, integration test, support UAT
  • Good understanding in procure-to-pay business process and integration with SAP
  • Minimum 1 year of experience in SRM 7.x UI 1.0 add-on
  • Experience in working with development team and co-ordinate with cross-functional stream
  • Experience in SRM data conversion for open purchase orders and contracts
  • Interface experience with non-SAP systems and Ariba Network
  • Expert & deep understanding in procure-to-pay business process and integration with SAP MM, PM, FI-CO, HR and CLM
  • Ability to debug ABAP code is a big plus
  • Experience with validated or controlled IT environments a plus
  • Customer focused and excellent communication skills are a must
  • Experience in creating test scripts, test data, perform unit test, integration test , support UAT and deployment activities
  • University degree in Computer Science, Engineering, Business Administration or equivalent experience.
  • Strong interpersonal skills; ability to work well on cross-functional project teams and foster team commitment to tasks
  • Strong verbal and written communication skills, with an ability to express complex business concepts in technical terms.
  • Strong analytical, problem solving, and conceptual skills
  • Must be a self-starter, results-oriented and have a track record of timely, high-quality deliverables
  • Strong written and oral communication skills in English              
  • Bachelor's Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent work experience
  • Experience in HP ALM (HP Application Lifecycle Management), a plus.
  • Experience in Document management tools like Condor, a plus.
  • Experience with cloud solution will be a plus.
  • Good command of English with outstanding communication skills.
  • Skills to envisage possible problems, determine and implement solutions.
  • Influencing, persuasion and negotiations skills, self-reliance and effective in management of a large area.
  • Experience in Pharmaceutical industry will be an added advantage.
11/14/19 Senior III, SAP SRM Petaling Jaya, Selangor

Key competencies

  • Strong background in IT service management such as ITIL.
  • Experience in applying IT service improvements methodologies like lean management, six sigma or others.
  • Ability to cooperate and communicate with people at different organization levels and within multidisciplinary teams.
  • Supplier performance management that includes KPI driven activities.
  • Knowledge on Project management (e.g.PMI, Prince2) and agile methodologies (like Scrum, Kanban, Lean) will have added advantage

Key responsibilities

  • Introduce and sustain the proactive approach that will lead to a reduced number of incidents and an increased system stability.
  • Sustain the timely delivery and estimation of new business requirement.
  • Provide functional and technical expertise for the business and IT stakeholders
  • Proactively identify incidents that are ‘candidates’ for being treated as PM with an objective of eliminating the root cause.
  • Analyzing problems for correct prioritization and classification
  • Coordinating actions of others as necessary to assist with analysis and resolution actions for problems and known errors
  • Monitoring progress on the resolution of known errors and advising incident management staff on the best available workaround for incidents
  • Assisting with the handling of major incidents and identifying their root causes
  • Manage Timely delivery of agreed enhancements.
  • Lead the estimations and feasibility of business requirements by providing high level but accurate estimates
  • Close collaboration with other team leads in regards to resources assignment
  • Identify opportunities for continuous improvements through problem management, knowledge management etc.

Mandatory skills

  • 6+ years of SAP SRM functional and configuration experience
  • Hands-on SRM & MM functional configuration skills
  • Experience in workflow configuration (application controlled and BRF process control
  • Optional: Experience in configuring UI5 add-on and FIORI
  • Expert in translating business requirements into functional design, collecting business
  • Experience in creating test scripts, test data, perform unit test, integration test, support UAT
  • Expert & deep understanding in procure-to-pay business process and integration with SAP
  • Minimum 1 year of experience in SRM 7.x UI 1.0 add-on
  • Experience in working with development team and co-ordinate with cross-functional stream
  • Experience in SRM data conversion for open purchase orders and contracts
  • Interface experience with non-SAP systems and Ariba Network
  • Expert & deep understanding in procure-to-pay business process and integration with SAP MM, PM, FI-CO, HR and CLM
  • Ability to debug ABAP code is a big plus
  • Experience with validated or controlled IT environments a plus
  • Customer focused and excellent communication skills are a must
  • Experience in creating test scripts, test data, perform unit test, integration test , support UAT and deployment activities
  • University degree in Computer Science, Engineering, Business Administration or equivalent experience.
  • Strong interpersonal skills; ability to work well on cross-functional project teams and foster team commitment to tasks
  • Strong verbal and written communication skills, with an ability to express complex business concepts in technical terms.
  • Strong analytical, problem solving, and conceptual skills
  • Must be a self-starter, results-oriented and have a track record of timely, high-quality deliverables
  • Strong written and oral communication skills in English              
  • Bachelor's Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent work experience
  • Experience in HP ALM (HP Application Lifecycle Management), a plus.
  • Experience in Document management tools like Condor, a plus.
  • Experience with cloud solution will be a plus.
  • Good command of English with outstanding communication skills.
  • Skills to envisage possible problems, determine and implement solutions.
  • Influencing, persuasion and negotiations skills, self-reliance and effective in management of a large area.
  • Experience in Pharmaceutical industry will be an added advantage.
11/14/19 Business or Senior Business System Analyst/Expert South San Francisco, California

Sr. Business Systems Analyst

Job Description



Function: Global GMP Computer Systems

Department: QSQM

Locations: SSF/Basel/Mississauga

Job Family: Quality Systems

Reports to: Head of QA Computer System Ownership          

Level: E3-E5    

Purpose:

As a Computer Systems Subject Matter Expert in Global Quality Systems and Management, you are responsible for understanding the strategic drivers and needs of the PT andPTQ organization. You will provide global subject matter expertise and support the implementation of the fit for purpose innovative solutions, including the information framework supporting the E2E process through the software development lifecycle (SDLC).   A successful candidate will have an agile and design thinking mindset and may perform as the Product or Process Owner.

Key Responsibilities/Tasks:

●     Provide Subject Matter Expertise for Quality Computer Systems (e.g., QMS, EDMS, ECM)

●     Ensure GMP Computer Systems and their operation are in compliance and fit for intended use according to applicable procedures

●     Approve major upgrades and the replacement and/or retirement of computerized systems through change management processes

●     Oversee system access process / procedures including periodic review of user access lists

●     Determine how to verify data integrity and propose strategies to achieve better data accuracy

●     Manage the escalation of issues to Business or IT and communicate/document status of issues where appropriate

●     Give input into and help define validation test strategy

●     Works with management to align projects to strategy and business objectives

●     Serves as ambassador for measurement, accountability and a disciplined approach to process improvement within the departmentand across functional area

●     Lead or participate in interdepartmentalteams, process improvements, or new system design

●     Leads meetings and or represents organization on projects, support and/or significant issues

●     Make informed decisions on software issues in collaboration with key stakeholders and abiding by system requirements

●     Ensure the smooth introduction of new functionality of the software as they are added

●     Regularly evaluate business use of the software and training materials to ensure alignment according to intended use

●     Initiate, investigate and close complex investigations and discrepancies

●     Lead or participate User Group Forums both locally and across sites

●     Attend or present at Vendor User Group Conferences

●     Possess analytical and/or computer skills sufficient to:

●     Understand data requirements and interdependencies

●     Solve problems through effective troubleshooting and suggest viable solutions

●     Continuously improve systems achieving increased compliance and efficiency

●     Use influence rather than authority when necessary to achieve results

Job Qualifications: Education, Experience, Knowledge and Skills:

●     Bachelor’s Degree in an applicable field or equivalent, MBA a plus

●     Minimum 7-10 years of work experience in biopharmaceutical production and an understanding of quality processes and procedures  

●     Experience with validated or controlled environments preferred

●     Demonstrated proficiency in Software Development Lifecycle (SDLC) 

●     Working knowledge of one or more information packages (e.g., QMS, EDMS, ECM)

●     Experience using Lean Production System (LPS) for continuous improvement opportunity evaluation

●     Leadership and project management, including understanding of life cycle planning

●     Demonstrated ability to influence and lead both with and without authority

●     Strong interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

●     Flexibility in problem solving, providing direction and work hours to meet business objectives

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.