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Date Job Title Job Level Location
11/15/18 Senior HR Business Partner Individual contributor South San Francisco, California

Purpose

  • Strategic business partner to leaders and leadership teams (LTs)
  • Consult, advise, coach and partner with the business on people and organizational needs
  • Ensure alignment with agreed group, functional and regional initiatives as well as business strategy and ensure successful local execution
  • Drive organizational effectiveness including change management for assigned client groups
  • Influence the overall people strategy; partner with leaders and LTs to develop and implement the people strategy/agenda for the business
  • Execute global and local HR processes and decisions and ensure meaningful communications
  • Develop and drive local HR initiatives that meet key business needs (aligned with global requirements

Key Responsibilities

  • Act as key HR point of contact, thought partner and sounding board for client LTs.
  • Identify, define and implement solutions that address the needs of the business while taking into account the broader implications (e.g. Group HR strategy, Genentech HR strategy/goals, other functions)
  • 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, Group HR strategy, Genentech HR strategy/goals, and/or function goals.
  • Ensure excellent alignment and execution of established human resources policies, procedures and Group, divisional and global functional HR initiatives.
  • Act as trusted advisor to managers and employees.
  • Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
  • Identify talent issues before they affect the business.  Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development.  Contribute to assessment/selection for senior leaders and other critical positions.
  • Determine most efficient and effective way to deliver services at affiliate level based on costs, ratios and appropriate Key Performance Indicators.  Collaborate with service organizations.
  • Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards, and other known relevant policies and guidelines.

This position is not eligible for relocation.

Qualifications, Experience, and Abilities:

  • 10 -12 years relevant experience 
  • Bachelor’s Degree or equivalent work experience 
  • Possess a full range of functional HR skills – workforce planning, recruitment, performance management, compensation, organizational development, talent management, succession planning, and change management
  • Broad HR technical knowledge and expertise
  • Previous HR experience in a global organization and/or biotech or pharmaceutical experience a plus
  • Proven track record for consistently meeting or exceeding goals
  • Strong partnering, project management, consultation, collaboration, and influencing skills
  • Demonstrated leadership skills

*LI-CG-LN1

11/15/18 Principal Solution Architect, Pharma Tech IT Individual contributor South San Francisco, California

The Principal Systems Solution Architect-Pharma Tech IT is responsible for building strategy, conceptualizing, planning, designing and implementing integrated information technology solutions in support of the PTD and PTI portfolio solutions. They will also be responsible for developing Information/Data Architecture and implementing analytical solutions to identify opportunities/trends/patterns, leveraging industry best practices and building a strategic plan to implement unmet needs.

Responsibilities:

  • Partner with IT teams and senior business leaders to provide strategic consultation for business process design/optimization, creating strategic roadmaps, performing rapid prototyping and implementing technical solutions to accelerate the fulfillment of the business strategic vision.
  • Develop and implement multiyear strategy & Roadmap consistent with the overall strategic needs of the business functional area.
  • Create strategic roadmaps for organizations to follow to recognize defined strategic goals and objectives and implement associated technology solutions. Present strategic recommendations to senior leaders from Business and IT. 
  • Assesses current state of solutions, defines future state needs, identifies gaps and recommends new technology solutions and strategic business execution improvements
  • Facilitate stakeholder sessions with personnel across all disciplines in the company to identify and define requirements, assess business processes and evaluate technology solutions. Formulate business and technology architectures comprised of diverse functional capabilities supporting business areas across the PT.
  • Stay abreast of emerging technologies and trends and perform rapid prototyping to benefit the business
  • Oversee and facilitate the evaluation and selection technology and product standards, and the design of standard configurations/implementation patterns

Qualifications:

  • Bachelor's degree in computer science, systems analysis or a related study, or equivalent experience
  • 10 to 15 years of experience in multiple IT disciplines/domains
  • Demonstrated track record of success in developing and implementing strategy and architecture for large enterprises.
  • Strong business knowledge in the Pharma/Biotech and DIA industry and associated processes is required. 
  • Deep expertise in multiple technologies domains (e.g. networks, systems, databases, security, etc.)
  • Ability to handle multiple priorities and to build a strong network and relationships (internally and externally) up to the executive levels across IT functions and the business. 
  • Demonstrated leadership experience, including the ability to successfully influence others to achieve objectives in an environment of competing priorities. 
  • Remains and keeps up-to-date with technology trends and emerging technologies
  • Ability to understand the long-term ("big picture") and short-term perspectives of situations.
  • Exceptional interpersonal skills in areas such as teamwork, facilitation and negotiation
  • Demonstrated ability to influence technology decisions at all levels (senior management & leaders to technical contributors & staff). Experience with creating materials and presenting information on complex and technical topics to a senior management audience. 
  • Experience managing change in a complex, matrix organization
  • Excellent analytical, presentation, written and interpersonal skills
  • Highly analytical with attention to detail. Proven ability to work in a fast-paced environment
  • Strong, track record of leading the implementation of complex solutions; Demonstrated ability to deliver results through partnering with stakeholders in IT and the business
  • Willing to travel globally as needed to coordinate and collaborate with colleagues and executives.
  • Knowledge of financial models and cost-benefit analysis is required

This position is not eligible for relocation

11/15/18 Scientist, Oncology Biomarker Development Individual contributor South San Francisco, California

We are seeking a highly motivated Scientist to lead biomarker efforts to support Cancer Immunotherapy drug development strategies. Previous experience in biomarkers, and a strong scientific background in cancer immunotherapy, immunology, and/or oncology is highly desirable. The successful candidate is expected to effectively interact with cross functional teams and thrive in an interactive, team-oriented culture, to envision and execute biomarker plans, to support or lead clinical and/or reverse translational research publications, and to promote collaborative efforts aimed to push novel biomarker science and/or innovative endpoints and technologies forward. We are looking for a candidate with excellent verbal and presentation skills. The incumbent is expected to contribute to drug development and to grow over time into externally recognized leader in translational science who influence the field of personalized medicine in oncology.

Primary responsibilities:

  • Provide exceptional scientific leadership to peers in OBD and assigned project teams (including clinical researchers, discovery scientists, bioinformatics scientists)
  • Design, implement and lead the biomarker strategy for Genentech’s cancer immunotherapy (CIT) products in multiple programs
  • Drive and manage scientific collaborations, both internal and external
  • Lead scientific initiative efforts aimed to incorporate novel biomarker endpoints in clinical trials.
  • Generate novel biological insights based clinic biomarker reverse translation research into specific tumor indications.
  • Support publications in high quality scientific, technical or medical journals
  • Represent OBD externally through interactions with key investigators and regulatory entities

Qualifications

  • PhD, MD, or PhD/MD degree in a relevant scientific field (e.g. immunology, molecular biology, cancer genetics, cancer biology, molecular oncology).
  • Minimum of 5-10 years post-doctoral experience in basic or translational research either in an academic and/or industry
  • Experience in clinical drug development and biomarkers is beneficial, including basic or advanced understanding of critical development functions, e.g. Clinical Pharmacology, Regulatory, Safety, Operations, Biostatistics, etc.
  • Solid record of publications in peer review scientific journals
  • Be able to distill complex issues and clearly articulate solutions
  • Ability to collaborate, lead, influence and motivate others.
  • Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment
  • Outstanding presentation and communication skills
11/14/18 Senior Manufacturing Engineer - CCP2 Downstream Frontline Individual contributor Vacaville, California

                                            

Job Description:

The Senior Manufacturing Engineer is responsible for the following:

  • Serve as a technical subject matter expert for all downstream processes (CIP, SIP, Buffer Preparation, Buffer Hold, Column Packing, Chromatography, Viral Filtration, Ultrafiltration/Diafiltration, Formulation, Drug Substance Dispensing, Cryovessel Freezing) to support make, assess, and release of GMP products.
  • Perform process monitoring of downstream unit operations to ensure process is performing as expected.
  • Perform troubleshooting of downstream unit operations when operational issues are encountered.
  • Evaluate unit operations (equipment design, automation configuration, procedural processes, user requirement specifications, functional specifications, Process Flow Diagrams, P&ID's, etc.) to determine opportunities to improve safety, quality, compliance, yield, efficiency, and reliability.
  • Participate in all aspects (owner, assessor) of change management processes to drive continuous improvement in the operation.
  • Interact with Quality, Regulatory and other functions and perform necessary process assessments, product impact assessments, and CAPA activities to support the closure of discrepant events including Quality investigations.
  • Establish strategies and associated documentation to perform equipment, and process commissioning activitives for downstream unit operations.
  • Participate in the generation, review, approval, and implementation of downstream manufacturing formulae (Automated recipes, worksheets, tickets, etc.) as well as SOPs, protocols, summaries, and other required processing documentation.
  • Serve as technical subject matter expert during health authority inspections.
  • Lead projects of high complexity in support of site goals.

Who You Are     

  • BS or MS degree in Engineering (Chemical, Mechanical, Electrical).
  • Minimum 8 to 12 years work experience in cGMP biopharmaceutical production.
  • Thorough understanding of Good Manufacturing Practices (GMP’s) as they apply to bioprocess manufacturing
  • Possesses subject matter expertise of multiple downstream processing operations
  • Possesses experience working within highly automated unit operations.
  • Knowledge of GMP documentation principles and change control theory.
  • Understanding of the main business systems including LIMS, BHDS, DMS and POMS.
  • Ability to work with a cross-functional teams including MSATS, Facilities, Engineering, QA, QC, Validation, Automation.
  • Successful demonstration of technical expertise, mechanical aptitude, problem solving, training ability, communication, and initiative.
  • Ability to provide on-call (off-shift) support for timely, technical guidance to enable business objectives.
11/14/18 Sr Instrumentation Technician Individual contributor Oceanside, California

Conduct diagnostics, calibrations, repairs, and modifications of industrial process control instrumentation. Assist with engineering and evaluation of new instrumentation and process control systems. Prepare and organize technical documentation and operational procedures. This is a journeyman-level position.

Job Responsibilities

  • Install, calibrate, troubleshoot, repair, and modify process control instruments or systems for manufacturing applications.
  • Install, calibrate, troubleshoot, repair, modify electronic, electromechanical, and pneumatic control devices for utility systems which support the manufacturing facilities.
  • Perform calibrations and scheduled preventive maintenance on analytical and other laboratory instruments.
  • Program/configure Instrumentation as needed for new installations and/or replacements
  • Assist with control systems start-up and validation.
  • Write calibration and equipment service reports.
  • Write calibration and preventive maintenance Standard Operating Procedures.
  • Provide general expertise and training to junior level technicians.
  • Test control systems and assist in validation of new and existing manufacturing facilities.
  • Collect and organize technical data from equipment manufacturers, equipment users, and engineering personnel.
  • Assist in preparation of engineering revisions.
  • Assist as technical SME with identification, purchase, and organization of spare parts.
  • Interact with Manufacturing, Laboratory, Maintenance, Metrology and Engineering staff members as well as other internal/external customers.
  • Perform 2nd level review for compliance to cGMP calibration SOPs and internal business processes.
  • Review and confirm completion of work orders in CMMS.
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
  • Follows 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 a positive safety culture in which no one gets hurt.

Job Requirements

  • Completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school, or an AA/AS Degree in a related science or engineering major plus substantial relevant on-the-job training.
  • 5 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job and minimum 2 years in a cGMP environment..
  • Good communication skills, both written and oral.
  • Prompt, consistent and orderly work habits.
  • Ability to read and interpret engineering documents and to produce shop schematics.
  • Ability to work independently on all but complex or controversial issues.
  • Ability to interact well with others in a team environment.
  • Strong organizational skills and time management skills.     
  • Thorough knowledge of the fundamental operating principles of industrial process Instrumentation and systems.
  • Must be proficient in ISA standards and practices for instrumentation.
  • Thorough knowledge of PID control theories and techniques.
  • Thorough knowledge of relay ladder logic and programmable controllers.
  • Ability to use Building Management Control System (BMCS) and Manufacturing Control System (MCS)
  • Available to work overtime when necessary and work varying shifts, including an On-Call program.
  • General knowledge of shop tool operation and safety.

Work Environment/Physical Demands/Safety Considerations

  • Schedule may include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
  • Expected to be on feet for 8 to 10 hours a day.
  • Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
  • Climb heights up to 30 feet by ladder.
  • Lift up to 60lbs may be required.
  • Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make-up or jewelry can be worn when working in the clean room environment.
  • Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
  • Work with hazardous materials and chemicals.
  • Wear air purifying respirator and wear necessary hearing protection.
  • Crawl, kneel and stoop and work in small work spaces.

This position is not eligible for relocation.

11/14/18 Biosample Operations Lab Supervisor Manager with direct reports South San Francisco, California

Relocation is not designated for this position.

The Biosample Operations Lab Supervisor (BOLS) is overseeing a high throughput and automated lab environment and is accountable for the design and implementation of scientific experiments and the development of new sample processing methods and techniques. 

The BOLS is responsible for ensuring that lab activities at BRM Operations fulfill request requirements and is responsible for achieving operational excellence in quality, service level, cost and compliance.

Primary Responsibilities and Accountabilities:

Training, Compliance & People Management  

  • Accountable for the development, authoring, reviewing, and maintenance of associated BRM Ops Controlled Documents (e.g. SOPs, Working Instructions, and Working Documents

  • Responsible for supporting the Lab Head and Head Operations in the implementation of new LIMS systems and associated SOPs, WIs, and WKDs.

  • Responsible for Line management of Sr. BLAs and/or BLAs at local sites, responsible for conducting ongoing individual performance, development, succession planning and training.

  • Supervision of BRM Scientific Manager’s related lab activities.

  • Accountable for task assignments and request fulfillment in associated Operations labs.

Operational Management support

  • Responsible for working with Sample Information and Business Services to provide operational information for forecasting, tracking and budgeting of service requests to enable an overview of future workload.

  • Responsible for implementation, upgrade, process development, and maintenance of new systems, instruments, methods and technologies for the sample handling and the sample processing laboratories.

  • Responsible for leading and supporting local and cross-functional projects/initiatives to maintain and expand lab services, improve operational efficiency and support biosample management activities.

Sample Handling, Storage, Processing

  • Responsible for interacting with cross functional internal and external service providers, researchers and study teams, as appropriate, to ensure the proper conduct of lab activities.

  • Accountable for the adherence of associated GCP compliant processes and local health and safety rules, for sample receipt, tracking, accessioning, processing, distribution and destruction, as well as to ensure all samples are of good analysable quality.

  • Accountable for the  communication and collaboration with Sample Information and Business Services in regards of sample information discrepancies so that high quality sample and associated data are provided to researchers.

  • Accountable for all associated study documentation and testing plans, i.e. completion, filing and archival in accordance with applicable regulations, corporate guidelines, and local SOPs, WIs, and WKDs.

  • Accountable for the coordination of biosample request fulfilment for clinical teams and for exploratory research purposes by scheduling lab activities, tracking request status, and defining operational and technical details of lab requests to be carried out by BLA or Sr. BLA.

  • Responsible for actively participating and positively contributing to the lab environment and team morale through activities including hands-on lab work as needed to ensure functional business needs are met.

  • Responsible to provide performance feedback on vendors and lab instruments to BRM Vendor Management.

  • Responsible for designing and overseeing scientific experiments.

Education / Qualifications:

Minimum: BSc or equivalent in a scientific, medical or healthcare subject (preferably immunology, genetics or molecular biology) with 5+ years experience in an appropriate laboratory setting.

Preferred: Direct and relevant experience in a pharmaceutical/biotech company, MSc, or PhD in scientific, medical or healthcare subjects, preferentially immunology, genetics and molecular biology.  2+ years of leadership or supervisory experience in academic or industry laboratory setting

Experience, Skills, Knowledge

  • Clinical or biological laboratory experience in a high-throughput, automated setting with responsibility for the efficient and timely processing and/or analysis of biological samples.

  • Experience in designing and executing scientific experiments as well as DNA/RNA extraction, QC and processing services.

  • Hands on experience in genetics and genomics and the manipulation and interpretation of resulting data.

  • Experience assessing, tracking and fulfilling research customer needs on an operational level in an efficient and timely way with a high degree of customer orientation.

  • Experience obtaining and documenting approval for sample use according to controlled documents and defined approval processes.

  • Experience defining requirements for and implementing Laboratory Information Management Systems.

  • Familiarity with the biopharmaceutical drug development process.

  • Planning, organisational and project coordination experience.

  • Proven experience in line management and supervision of the work of others.

  • Direct line management experience in a regulated lab setting would be a plus.

  • Proficiency with PC computer systems.

  • Strong organizational, multitasking, and prioritization skills.

  • Strong written and oral communication skills, fluent in English (written and verbal)

  • Requires attention to detail and accuracy in data entry while maintaining study timelines.

  • Strong analytical and problem solving skills, paired with partnering and performance skills.

  • Team player with strong interpersonal skills and the ability to build effective working relationships inside and outside their functional area with experience of working in multi-cultural teams.

  • Demonstrated ability working under pressure and to tight timelines.

  • Good level of initiative and the ability to work independently and with minimal supervision.

#LI-PD-BR1

    11/14/18 Sr. Manager, Paid Digital Media Platforms Individual contributor South San Francisco, California

    Position Summary

    Digital Customer Experience (DCX) is a functional group within Genentech Business Operations (GBO) comprised of experienced digital experts who partner across CMG to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

    The purpose of this role is to be the subject matter expert and solution owner for paid digital media platforms within DCX. They will be responsible for understanding business and customer needs, identifying opportunities for automation and innovation, designing and implementing solutions that allow for scale and efficiency.

    Key Responsibilities:

    • Accountable for solution architecture and roadmap of media platform strategy
    • Responsible for platform-as-a-service performance as measured by the enablement of business outcomes
    • Responsible for proposing technology solutions and getting buy-in from functional leaders/squad leaders, securing investments and then leading teams to implement such solutions
    • Define and manage solution architecture from idea to implementation ensuring that solution supports the business objectives, while maintaining the integrity of the overall enterprise architecture
    • Provide technical leadership to team members and vendor resources (onsite and offshore). Manages platform/technology vendors, including contracting
    • Proactively identify and determine solutions to execute business objectives
    • Represent technical POV in cross-functional team meetings for defining new requirements or resolving business issues as needed.
    • Maintain product technical knowledge and lead architecture design discussions
    • Work with other platform leads and architects to design and implement high availability, high performance systems in support of strategic goals.
    • Review the team’s work to ensure compliance to standards and best practices.
    • Be an owner in defining and overseeing overall development/data governance and standards.
    • Specialized knowledge in the AdTech practices and trends
    • Leads and participates in cross CMG efforts requiring the integration of data and systems in order to drive business and customer outcomes
    • Drives efficiency and improvements in media/social operations and strategy by advising/training on the effective use of platform/data

    Skills and Competencies

    • Ability to anticipate business needs, drive clarity in ambiguous situations and strong problem-solving skills
    • Excellent planning and executional skills; ability to build strategies and plans that align with business priorities
    • Strong system and data Integration skills, as it relates to digital marketing
    • Solid large project management skills to ensure that all project deliverables are on time and high quality
    • Strong Business Analysis skills, documenting and developing operational and governance processes
    • Strong understanding of Cloud technologies
    • Strong critical thinking and analytical skills
    • Strong collaboration & communication skills
    • Strong vendor and stakeholder management & negotiation skills
    • Ability to forecast and manage resources for operations
    • Ability to gauge the feasibility, impact and risks of proposed enhancements & innovations
    • Ability, comfort & commitment in/to operating in a highly regulated environment and industry, which requires understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws and regulations

    Qualifications

    • Bachelor’s degree in Engineering or a related field
    • MBA or other related graduate degree preferred

    Experience

    • Overall technology experience of 10 years
    • 5+ years of related work experience, preferably in paid media, marketing operations, or advertising operations
    • Advanced knowledge of campaign management, ad server and bid management platforms (Google/DoubleClick experience a plus)
    • Experience managing paid search, display, and social advertising campaigns
    • Google AdWords, Google Analytics, and/or Bing Ads certification (additional certifications are a plus)
    • Knowledge of social media platforms and measurement tools
    • Experience with data integrations using strong data management principles

    #LI-Comm-KG1

    11/14/18 Sr. Manager, Relationship Management & Email Platforms Individual contributor South San Francisco, California

    The digital center of excellence is a functional group within Genentech Business Operations (GBO) comprised of experienced digital experts who partner across CMG to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

    The purpose of this role is to be the subject matter expert and solution owner for our RM and email marketing/communications platforms within the digital COE. They will be responsible for understanding business and customer needs, identifying opportunities for automation and innovation, designing and implementing solutions that allow for scale and efficiency.

    Key Responsibilities:

    • Accountable for solution architecture and roadmap of RM & email marketing/communications platforms
    • Responsible for platform-as-a-service performance as measured by the enablement of business outcomes
    • Responsible for proposing technology solutions and getting buy-in from functional leaders/squad leaders, securing investments and then leading teams to implement such solutions
    • Define and manage solution architecture from idea to implementation ensuring that solution supports the business objectives, while maintaining the integrity of the overall enterprise architecture
    • Provide technical leadership to team members and vendor resources (onsite and offshore). Manages platform/technology vendors, including contracting
    • Proactively identify and determine solutions to execute business objectives
    • Represent technical POV in cross-functional team meetings for defining new requirements or resolving business issues as needed.
    • Maintain product technical knowledge and lead architecture design discussions
    • Work with other platform leads and architects to design and implement high availability, high performance systems in support of strategic goals.
    • Review the team’s work to ensure compliance to standards and best practices.
    • Be an owner in defining and overseeing overall development/data governance and standards.
    • Specialized knowledge in the RM & email marketing practices and trends
    • Leads and participates in cross CMG efforts requiring the integration of data and systems in order to drive business and customer outcomes
    • Drives efficiency and improvements in RM & email operations and strategy by advising/training on the effective use of platform/data

    Skills and Competencies

    • Ability to anticipate business needs, drive clarity in ambiguous situations and strong problem-solving skills
    • Excellent planning and executional skills; ability to build strategies and plans that align with business priorities
    • Strong system and data Integration skills, as it relates to digital marketing
    • Solid large project management skills to ensure that all project deliverables are on time and high quality
    • Strong business analysis skills, documenting and developing operational and governance processes
    • Strong understanding of Cloud technologies
    • Strong critical thinking and analytical skills
    • Strong collaboration & communication skills
    • Strong vendor and stakeholder management & negotiation skills
    • Ability to forecast and manage resources for operations
    • Ability to gauge the feasibility, impact and risks of proposed enhancements & innovations
    • Ability, comfort & commitment in/to operating in a highly regulated environment and industry, which requires understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws and regulations

    Qualifications

    • Bachelor’s degree in Engineering or a related field
    • MBA or other related graduate degree preferred

    Experience

    • Overall technology experience of 10 years
    • 5+ years of experience in Database/RM marketing strategies and technologies
    • Experience architecting and implementing Campaign Management systems
    • Experience with Adobe platforms a plus
    • Experience with data integrations using strong data management principles
    • Experience managing and implementing email platforms

    #LI-Comm-KG1

    11/14/18 Artificial Intelligence (AI) Engineer, gRED Early Clinical Development Individual contributor South San Francisco, California

    Genentech’s Early Clinical Development (ECD) department is seeking an Artificial Intelligence (AI) Engineer reporting to the AI Team Lead.  The ECD AI group impacts Clinical Operations in trial design, planning and predictive tools.  The role will require cross-functional interactions with early research in discovery chemistry (CADD) and DMPK.  The AI Engineer will act as a consultant and be required to both establish and apply new AI methods to specific problem domains within those functions.

    The AI Engineer will primarily be responsible for the development and the deployment of deep learning methods in early research with particular focus on the application to early discovery chemistry.  The main method will be a generative method for proposing small molecule with desirable predicted properties. The position will also apply AI methods to modeling in the DMPK and early discovery chemistry.

    Responsibilities

    • Lead key AI pilots to ensure successful completion and develop plans to integrate capabilities into the normal early clinical development process
    • Development of new and novel Deep learning methods for reinforcement learning and generative methods
    • Application of deep learning methods to problems and support in early discovery and research with particular application to small molecule chemistry
    • Develop the software tools and library for application of deep learning methods, and train other colleagues within gRED and cross-Roche to develop and use the tools in their applications
    • Development of deep learning methods for adverse event prediction
    • Possess in-depth knowledge of multiple real-world data assets and share information about these data to business partners and the ECDi team.

    Qualifications

    • Experience (7+ years) and a proven track record in software engineering, must have public and private repositories and track record of contribution to an open source package, such as DeepChem
    • Python, Tensorflow, Scikit Learn,  C++ PyTorch, DeepChem,
    • Strong analytical and problem-solving skills
    • Excellent oral and written communication skills
    • Ability to lead cross functional multi-disciplinary teams
    • Able to work in teams and collaborate with others to solve the most challenging business problems
    • OEChem, RDKit, SPARQL, and SQL are a plus

    Education

    • Phd in Artificial Intelligence and machine learning with particular emphasis on molecular property prediction

    #LI-gRED-KM2

    11/14/18 Statistical Scientist Individual contributor South San Francisco, California

    The Statistical Scientist partners with senior scientists in biostatistics, clinical, safety, epidemiology, regulatory, research, and manufacturing on clinical development projects, research applications, development science applications, and/or product manufacturing applications. This typically includes partnering with senior scientists in the creation of strategies to address drug development needs and designing experiments, and evaluating and preparing study results for health authorities and the medical/research community.  For clinical development programs, the Statistical Scientist typically is the lead Biostatistics representative on cross-development global clinical study teams.

    Clinical Development:

    • Member of clinical team, collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams
    • Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters
    • Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained.  Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming.
    • Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations.  Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
    • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
    • Participates in health authority meetings

    Functional Area:

    • Understand and apply business requirements and processes.  Participates in functional training.
    • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.

      Job Qualifications:

    • Ph.D. in statistics or biostatistics with at least 2 years of experience or a master’s degree in statistics or biostatistics with at least 5 years of experience designing and analyzing clinical trials
    • Excellent understanding of theoretical and applied statistics.
    • Good knowledge and experience applying statistical methods to drug development
    • Experience with statistical software packages such as R, SAS, and JMP.
    • Excellent Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)
    • Evident Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
    • Evident Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects)
    • Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
    • Ability to work independently on multiple projects.

    #LI-PD-BR1

    11/14/18 Scientific Researcher, Biochemical and Cellular Pharmacology Individual contributor South San Francisco, California

    We are seeking a talented Scientific Researcher to join the Biochemical and Cellular Pharmacology Department at Genentech. The successful candidate will be part of a highly collaborative teams finding and characterizing small molecule drug candidates. They will be responsible for the development and execution of medium-high-throughput biochemical, cell-based and phenotypic assays to support our drug discovery projects. This position requires working with multidisciplinary teams, including biology team members from Discovery Research, Medicinal & Computational Chemistry, DMPK and Safety Assessment. A strong candidate will be able to demonstrate experience in applying innovative technologies to biology and molecular pharmacology, and generating and analyzing quantitative data. The candidate will have the opportunity to conduct detailed data analyses and will present these to project teams.

    Requirements:

    The qualified individual will possess a bachelors or master’s degree in Biochemistry or a related field with at least 2 years of relevant research experience in academia, biotechnology and/or pharmaceutical industry. The position requires a working knowledge of chemistry and statistics. Familiarity with lab automation and/or data science programming (Python, R, MatLab) would be advantageous.

    #LI-gRED-RM1

    11/14/18 Intern- Pharma Technical Operations- Process Engineering Entry Level South San Francisco, California

    This internship position is in the Manufacturing Sciences and Technology (MSAT), Process Engineering (PE) group, which supports cGMP manufacturing of both Clinical and Commercial products at Genentech’s South San Francisco (SSF) Manufacturing facility. The Process Engineering group works in collaboration with Manufacturing Operations, Process Technical Development, Scheduling & Maintenance, and Quality in order to ensure continuous, efficient, and safe production of multiple biologics. We are responsible for process monitoring, receiving new processes from Process Technical Development or other manufacturing sites, continuous process improvement, and troubleshooting manufacturing unit operations spanning both Drug Substance and Drug Product. Process Engineering relentlessly pursues scientific excellence, customer satisfaction and employee development in achieving its goals.

    You will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Specific responsibilities for this position will include:

    • Adherence to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.
    • Implementation of projects with a focus on safety and/or compliance risk reduction, process and equipment robustness improvement, and capacity/productivity/efficiency enhancement.
    • Interpretation of process data with a focus on in-depth understanding of process at manufacturing scale for identification of continuous improvements.
    • Creation/revision of standard operating procedures and manufacturing tickets in collaboration with operations and technical writing staff.
    • Summarization of projects highlighting the accomplishments and poster/oral presentation at staff/department meetings.

    Requirements:

    To be eligible for this position, the candidate must be currently enrolled in an accredited college or university.  Candidate must possess good problem solving, interpersonal, communication, and team skills.  Candidate must be a self-starter with a strong focus on quality, details, and results.  Seeking candidates currently studying in life sciences and/or engineering with an emphasis in the following majors:

    Applicable Majors:

    11/13/18 Senior Manager, Co-pay Donation Operations - Corporate Relations Individual contributor South San Francisco, California

    Genentech’s Co-pay Solutions Team supports patients who cannot afford their medicine by making charitable donations to independent Co-pay Assistance Foundations (CAFs) that provide financial assistance.  The Co-pay Solutions Operations Senior Manager plays a critical role  by leading quarterly donation recommendations, forecasting patient need across our priority disease areas, and developing standardized/automated tools for decision support.  The role requires deep analytical capabilities, strategic agility, ability to influence, and superior communication skills.

    Key responsibilities of this position:

    • Develop Quarterly Donation Recommendations to support patient access in line with our mission and compliance standards.  Drive quarterly decision-making process, culminating in final approval by Genentech leadership. Execute quarterly donations in response to CAF requests. 
    • Forecast patient support needs across priority disease areas so that we can make informed donation recommendations in response to CAF requests.
    • Develop streamlined, standardized, and automated tools to support scenario building and support donation decision-making
    • Maintain and support TM1 database and Genentech Funding Request System (gFRS)
    • Synthesize and distill complex information and present holistic view to leadership
    • Lead the evolution and operationalization of our donation strategy in response to the changing landscape, adhering to our high standards of compliance while maximizing co-pay resources to support patient support organizations
    • Support team initiatives as needed (ex: Budget Planning, Quarterly Business Reviews, Extended Team requests, Extended Team offsites)
    • Partner and act as Subject Matter Expert with Compliance Manager on compliance questions/concerns related to Operations

    Qualifications:

    • Robust analytical skills and proficiency in Excel are required.  Advanced capability with Forecasting, (TM1) database applications, and Excel are a plus
    • Strong executive presence, excellent communication skills and ability to influence, are required
    • Nuanced understanding of healthcare landscape including trends related to policy, reimbursement and patient access
    • Significant critical thinking skills and a proven ability to understand and distill complex information
    • 7+ years of business experience with significant understanding of the Bio/Pharma industry and operations
    • Internally motivated with a commitment to accuracy, quality and attention to detail
    • Bachelors Degree required; MBA or other related graduate-level degree desirable
    11/13/18 Training systems specialist Individual contributor South San Francisco, California

    Purpose

    The Learning Technology Analyst role is defined for a duration of 2 years to specifically support the implementation of PT’s “new ways of learning initiative”,  in a global and highly regulated environment.

    The initiative includes several components. Besides a new learning management system (Cornerstone), it includes upgrades and replacements of existing interfaces (e.g., electronic document management system, identity management etc..), data migration from existing learning management systems to Cornerstone, developing new reports for analytics and business operations, standardizing learning processes, training, and supporting team members for various implementation activities.  This is a hands on, tactical role and work closely with the PT learning business process owner, PT business process managers (BPms), PT learning business partners, various IT groups, the PT LMS implementation team members, the PT learning network analysts and the shared service center for learning (SSC).

    Tasks & Responsibilities

    • Partner with the PT learning center of excellence (CoE) team members and the Cornerstone project team to ensure the successful implementation of Cornerstone, including all phases of implementation.
    • Drive efficiencies through the use of technology.
    • Support the design and development of tools to support analytics and metrics collection.
    • Provide routine operations support e.g., trouble shooting, running reports, supporting inspections, developing and cascading system availability communications.
    • Support, ad hoc requests for system access requests (QuickBase), discrepancy root cause analysis and discrepancy closure activities.
    • Understand and make connections between the different learning tools, technologies and processes and contact the various IT groups and vendors for support as needed.
    • Participate and or lead user group meetings to share information, answer questions, issue resolution, and share best practices.
    • Work closely with the PT Learning CoE team members to provide both technological and business process support to the PT learning network.
    • Assist with process mapping and continuous improvement activities.
    • Manage system lifecycle for training technology from initial development to retirement.
    • Provide web support for department website and portal.
    • Teach others to identify, apply and use learning related technologies.
    • Work independently or in collaboration with other training professionals across the PT learning network to support project work and routine operations activities.
    • Actively seek feedback from all levels to keep communications open and timely.
    • Create, share and adopt best practices.
    • Lead and/or actively participate in non-technological business process improvement projects.

    Qualifications: required educations / experiences / competencies

    Education and Experience:

    • 8-11 years experience with Bachelor degree in Computer Science, Business (or related discipline) or comparable work experience; 6-9 years with an advanced degree in related field.
    • Project Management Certification desired.
    • 3 - 5 years experience in a training, learning and development, technology or related role.

    Technical Requirements:

    • Advanced skills in Excel (with complex macros), data analytics (joining data from various sources), and ability to write SQL queries etc..
    • Demonstrated ability to establish and manage work priorities and timelines to achieve results.
    • Proficient in computer skills across multiple applications (i.e., report applications, data bases, LMS, development tools etc.).
    • Knowledge of GMP and FDA regulations and training requirements.
    • Able to work effectively in a matrix organization across virtual teams, multiple time zones and multiple cultures.
    • Ability to work independently with minimal supervision and ability to research solutions.
    • Excellent verbal and written communication and collaboration skills to work with individuals who have varying levels of technology skills.
    • Strong analytical and project management skills and ability to research and address systems issues.
    • Ability to influence and negotiate through formal and informal networks.
    • Knowledge of key training metrics for evaluating training efficiency and effectiveness.

    Competencies:

    • PT Behaviours and Lean Mind set: Embrace PT lean principles and methods for continuous improvement and new ways of working. 

    Other:

    • International and US travel up to 10% may be required.
    • Non-standard work hours will be required to work with global teams.
    • This position is based in South San Francisco and does not have a relocation budget.

    11/13/18 Instrumentation Specialist, Site Services Individual contributor South San Francisco, California

    Provide organization, communication, oversight, leadership, training, and administration of internal and external programs and business processes within the Instrument Services department. Design and implement documentation and work process improvements, allowing Instrumentation Technicians to focus on routine maintenance activities.

    Responsibilities:

    • Develop new and revise existing preventative maintenance and calibration procedures in the Instrument Services and Metrology groups.  Work within the change control program to implement the new documents.
    • Act as an change owner, assessor and/or approver for new and existing preventive maintenance and calibration procedures in the Instrument Services and Metrology groups.
    • Approve technical documentation as the Master Data SME and Maintenance Strategy SME for Instrument Services.
    • Serve as an interface to the Training group to ensure that all qualifications for staff in the Instrument Services and Metrology groups are up to date.
    • Serve as an interface to the Quality Assurance group to assist in aligning maintenance and calibration practices across the network.
    • Participate on teams representing Instrument Services and Metrology, providing active participation and leadership as necessary per the team's charter and the specialist's role on that team.
    • Prepare documentation for inclusion of master data into the Computerized Calibration Management System (CCMS) and Computerized Maintenance Management System (CMMS). Work with equipment owners and project managers to ensure that all data is consistent and appropriate. Authoring and/or reviewing of measurement data templates (MDT) for the CCMS is a part of this task.
    • Recommend, champion, and administer process improvements, especially with respect to advanced calibration and troubleshooting techniques, e.g., Predictive, Test Uncertainties, Instrument Specifications Evaluation, Calibration Intervals, etc.
    • Establish and sustain clear communications within cross-functional departments and strategic business units, along with external contractors, vendors, and service providers.
    • Provide support for internal and external audits and inspections for the maintenance and calibration programs.
    • Evaluate instrumentation specifications and design applications for new instruments and analytical technologies to identify any potential issues that could result in operational vulnerabilities affecting regulatory compliance, excessive costs, process vulnerability, reliability, and reduced system availability.
    • Contribute to the identification and procurement of appropriate test, service, and safety equipment, as well as spare parts and materials for proper maintenance and repair of process and laboratory instruments and equipment.  Approve Material Master and BOM requests for inclusion into MRO Stores and the CMMS.
    • Provide fault diagnosis, trending, and troubleshooting expertise, while applying advanced theories and principles of metrology calibration and automation engineering, addressing issues that directly impact system or equipment availability and reduction in production capabilities.
    • Ability to work under only very general supervision and guidance, with more detailed instructions on new assignments.  Work is reviewed for soundness of judgment and overall adequacy and accuracy.  Works with manager to establish priorities and timelines.

    Education and Experience:

    • Completion of a B.S. degree in Science, or an Electronics Engineering 2-year curriculum at a technical school, or an AA I AS Degree in a related science, or engineering major including substantial relevant on-the-job training.
    • 3-5 years of progressive experience in analytical or process control instrumentation or closely related job with a proven performance record is highly desirable.
    • 3-5 years as a field service technician / engineer or as service contractor for an analytical instrument manufacturer is desirable.

    11/13/18 Business Process Specialist Team Lead Basel, Basel-City

    As a Business Process Specialist Team Lead, you are part of the Global Procurement organization and will report directly to the Global Business Process Owner. You will be a part of the Process & Infrastructure team and accountable for defining, monitoring and improving processes across Pharma and Diagnostics.

    Global Procurement is a key function that delivers value to Roche by using market knowledge, domain expertise and business insights in the procurement of goods and services and the management of Roche’s third-party spend. Through collaboration with our external suppliers and internal business partners, Global Procurement helps bring innovative tests and medicines to patients.

    In this position, you will manage the Business Process Specialist pool that supports Global Business Process Managers (GBPMs) based on process alignment and capacity requirements. You will support the GBPMs in developing, monitoring, improving and deploying processes and in developing the link into meaningful IT systems. In day-to-day operations, we require time and effort to manage a moderate number of cross-divisional global, regional and local procurement partners. The GBPS works with a broad range of functional partners.

    Your responsibilities:1. Develop People

    One meaningful part of this position is to develop and guide Procurement staff and project related staff, as appropriate. We need someone to provide opportunities for professional development and contribute to feedback for project-related staff.

    2. Core Accountabilities
    • Lead the Business Process Specialist team in supporting GBPMs for a specific section of the Procurement process and the alignment of IT systems.
    • Maintain an overview of resource planning against GBPO prioritized initiatives and assist GBPM with process definition, monitoring, improvement and roll-out, and business acceptance. Raise non-global process compliant practices. Identify and monitor corrective actions.
    • Support the User Requirement Specifications (URS) compilation to design core solutions. Support the definition and documentation of the User Acceptance Test (UAT) scripts for core solutions and any subsequent enhancements.
    • Support the definition of the global core solution training material requirements and all required updates of these materials due to enhancement requests, as well as supporting Procurement Solution Project Managers in the content creation.
    • Ensure alignment with overarching strategy by working closely with the GBPO, GBPMs and other Process Specialists team members to ensure delivery of Global Procurement strategy.

    You will ensure the description and validation of requirements, to incorporate them into meaningful frameworks, methodologies and tools. This includes supporting the definition, implementation and measurement of performance metrics and KPI’s for all the related sub-processes. Help monitor system data quality and requested maintenance.

    We are looking for someone who will analyze change impact by supporting the analysis of process change impacts. You will help to make them fully understood and considered as needed before the implementation of the process design changes.

    Additionally, you will document process changes and prepare the case for change and prioritization proposals in alignment with GBPM for Maintenance & Enhancements (M&E) review board meetings.

    With your engagement, we will drive the identification and resolution of process design issues between sub-processes with an end-to-end mindset, including managing change reviews from global, regional and local functions. You will drive the resolution of long-pending system issues.

    3. Function Accountabilities
    • Support the team lead with the budgeting process to maintain the annual operating activities of the team.
    • Manage documentation and knowledge sharing so that global end-to-end processes are available.
    • Ensure relevant process documentation and share them through established Key Account Management communities. Work closely with GBPMs and Category and Region Key Account Managers to ensure global end-to-end process communication is distributed to relevant user communities.

    Your Qualifications:
    • Relevant Master’s degree. 7+ years Procurement, Supply Chain, Finance and/or Process Management. 5+ years process management experience.
    • Understanding of technical and business IT solutions, excellent communication, influencing and networking skills.
    • Excellent analytical and soft skills as well as Business level fluency in English
    • The ability to challenge the status quo and to work independently.
    • Understanding of Roche’s Business Processes and experience in Process Reengineering is desired.

    Pharmaceutical industry or management consulting experience is desired. Lean Six Sigma Green or Black Belt knowledge is a plus.

    This is a global role and the location is flexible if justified. The preferred location is either South San Francisco, US, or Basel, Switzerland. If you are passionate about this role and are not currently based at one of the preferred locations listed, please contact the recruiter for more information.

    This Position will be posted until the 23rd November 2018.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    If you have questions then please check our FAQs and videos on careers.roche.ch/faq.

    11/13/18 Principal Scientist, Oncology Biomarker Development – Lung, Head and Neck Cancer Manager with direct reports South San Francisco, California

    We are seeking a dynamic thought leader in oncology translational sciences / medicine to join the Oncology Biomarker Development (OBD) group at Genentech. The Principal Scientist of predictive diagnostics will provide exceptional scientific and strategic leadership for therapeutic franchises and disease-based biomarker activities in Cancer Immunotherapy with a specific focus on lung and head and neck cancers. The position may include oversight of targeted drugs outside of the cancer immunotherapy space that are being developed primarily in lung or head and neck cancers.  Leading a team of lab-enabled scientists / Sr. scientists, the incumbent will be responsible for development and oversight of the Franchise biomarker strategies and ensuring successful execution of drug-diagnostic co-development in collaboration with the Companion Diagnostics Development group within OBD. The successful candidate may also serve as a Biomarker Subteam leader for one or more molecules within their Franchise area. This role requires an individual with outstanding communication and leadership skills, as well as the ability to build strong relationships with key stakeholders in product development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific and strategic leader, one who can readily bridge between a cutting edge Research environment and a fast-paced clinical and product development organization. The successful candidate is expected to drive the publication of biomarker data in high quality scientific, technical or medical journals, to represent the department and programs at external meetings, to be a key representative to our investigators, and to promote collaborative efforts to forward the biomarker sciences field in general. This is an important leadership role with substantial visibility within Genentech / Roche organization.

    As a Principal Scientist, you are expected to:

    • Lead and mentor a group of Scientists that lead biomarker programs and medical affairs managers in late stage development
    • Provide exceptional scientific leadership across multiple molecule teams, to your peers within OBD and to the organization in general with a particular focus on late stage development
    • Lead biomarker strategies at the lung franchise level, and lead one or more biomarker subteams
    • Represent biomarker related strategies and plans to late stage development review forums, decision committees and project teams.
    • Lead biomarker related regulatory strategies and interactions with health authorities around the globe including review of relevant regulatory documents
    • Lead and drive scientific and technical innovation collaboratively with other members of the Department (experience with NGS and blood-based technologies preferred)
    • Drive high quality publications in high impact scientific, technical or medical journals
    • Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
    • Participate and thrive in an interactive, team oriented culture

    Requirements

    • PhD, MD or PhD/MD degree in a relevant scientific field (e.g. Oncology, pathology, molecular biology, cell signaling, cancer genetics, cancer biology, bioinformatics)
    • Minimum of 5-10 years post-MD/PhD experience in an academic and/or industry setting
    • Ideally experienced in clinical drug development for lung cancer, including advanced understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine, Clinical Pharmacology, Regulatory, Safety, Operations, Biostatistics, etc.
    • Ideally, at least 5-8 years of prior experience managing a group of research associates, scientists, managers, etc.
    • Significant experience leading subteams / teams; ability to drive to effective decisions and enable execution on programs
    • Consistent record of innovative contributions to translational sciences / development in lung cancer as evidenced by first / senior-authored publications in top-tier journals, patent authorship, filings
    • Recognized scientific leadership in lung cancer, National and / or International scientific reputation, evidenced by presentations at key national/international meetings
    • Strong passion to drive clinical innovation to improve outcomes for patients
    • Outstanding communication skills; ability to:
      • Lead, influence and motivate others
      • Navigate complex and difficult situations
      • Show strategic agility and ability to interface with multiple stakeholders
      • Distill complex issues and clearly articulate / present solutions

    #LI-gRED-RM1

    11/13/18 Senior Safety Data Scientist Individual contributor South San Francisco, California

    Job Description:

     

    The Senior Data Scientist (SDS) combines aspects of Safety Science and Data Science/Programming activities to enable bringing automation and other technologies to improve the efficiency and effectiveness of Core  Safety Science.  For example, this can include automation for Safety Narratives, developing Robotic Process Automation (RPA) for relevant Safety Science activities, etc.  The SDS should have relevant Safety Science experience including performing signal detection and evaluation activities; writing and contributing to aggregate reports and risk management activities as well as contributing drug safety inputs to activities supporting Clinical Development, Drug Safety Reports, etc. 

    In addition to the core SS knowledge, this individual should have a working knowledge of typical programming languages used to support Safety and Data Science activities including VBA, Python, JMP Clinical, and Velocity.  The individual must be able to design, develop, and implement automation/RPA to meet Safety Science needs: for example automating Clinical Safety Narrative templates and generation to support key Safety deliverables.  Additional skills in common Safety Analytic techniques, Epidemiology, Computer Science/Machine Learning, and Biostatistics are a highly desired.

    Job Responsibilities:

    • Represent Safety Data Science/Core Safety Science with business process owners on processes executed by Safety Science
    • Responsible for coordination and collaboration with automation/IT vendors (as appropriate) servicing Safety Science projects and activities
    • Acts independently to assess, develop, and otherwise oversee applications of automation to processes supporting both pre- and post-marketing safety science
    • Leads and oversees major automation initiatives involving intelligent automation/machine learning for Core Safety Science deliverables, including CSR Narrative Automation
    • Takes on responsibility for more complex deliverables
    • Takes on team leadership responsibility in order to manage and complete technical projects requiring more coordination and insight for low-medium priority projects, as appropriate
    • Understands how safety activities contribute to development goals and takes measures to implement intelligent automation, RPA, or machine learning solutions maximize safety value to the organization
    • Takes on speaking opportunities, team leadership, and publishing opportunities, when available
    • Demonstrates independence and high competence in the conduct of all safety data science responsibilities and presentations
    • Demonstrates behaviors consistent with Roche values and engenders confidence from senior management

    Education, Skills, and Experience:

    • Prior experience in safety science/pharmacovigilance is required (? 1 year)
    • Must have PhD with relevant technical experience (Programming, Machine Learning, or other Quantitative Background) OR MA/BA with at least 10 years pharmaceutical and programming experience in clinical development or drug safety
    • Understanding of GxP and regulated processes and end to end clinical trial lifecycle
    • Good knowledge of US and EU pharmacovigilance regulatory requirements and practices
    • Excellent written and verbal communication skills and ability to present and critically discuss clinical and technical data in both internal and external discussions
    • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
    • Team player with ability to function in a multi-disciplinary environment
    • Self-motivated, able to prioritize and plan effectively
    • Attention to detail
    • Fluent in English (verbal and written)
    • Good negotiating and influencing skills
    • Good computing/IT skills; specifically including working knowledge of VBA, Python, SQL, JMP Clinical, and Velocity
    • A proven track record of ability to design and implement automation tools into routine business practices

    Travel Requirements:

    • Available to occasionally travel nationally and internationally.

    11/13/18 Clinical Specialist, Lytics - Boston, Worcester and Springfield, MA Individual contributor South San Francisco, California

    Level: E3
    Franchise: Lytics
    Territory: Boston, Worcester and Springfield, MA

    Major Accounts: MGH, Tufts, UMass, St Vincents, Lowell, Norwood, Mt Auburn, Newton

    Lytics Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.


    The applicable therapeutic area / disease states are: Central Venous Catheter Management and Acute Ischemic Stroke

    Reports to: Division Manager, Franchise Sales

    Example Duties and Responsibilities:

    • Responsible for meeting or exceeding assigned sales targets
    • Develops robust territory business plans
    • Develops strong and long-term relationships with customers in all assigned accounts
    • Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
    • Monitors operating costs and compliance with territory budget
    • Complies with all laws, regulations and policies that govern the conduct of GNE activities
    • Business travel, by air or car, is regularly required.  Overnights will be required.

    Key Competency Profile:

    • Achieving Results
    • Technical and Business Expertise
    • Inspiring & Influencing
    • Teamwork & Collaboration
    • Decision Making

    NOTE:

    • This is a remote position.
    • This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. This is a remote position. 

    You are a person with the following qualifications and experience:
    (unless stated as "preferred" or "a plus," all other criteria is required)

    • Bachelors Degree
    • Average of 4 or more years' work experience
    • Previous sales experience in the pharmaceutical, biotech, or related industry is preferred
    • Previous experience in academic centers or institutions or higher learning is preferred
    • Previous experience with hospital administration is preferred
    • Proven ability to execute quality initiatives in hospitals and institutions is preferred
    • History of promoting injectable, acute care products is preferred
    • Previous Genentech sales experience is preferred
    • Proven track record of meeting or exceeding objectives & goals
    • Previous experience in achieving specific sales plans or other financial targets is preferred

     *LI-COMM-MG1

    11/12/18 Associate Validation Engineer (Temporary Assignment) Individual contributor South San Francisco, California

    This position will be employed through a third party vendor, not by Genentech, and will be based at Genentech's South San Francisco Manufacturing site.

    Genentech has a temporary assignment available in our South San Francisco Manufacturing facility. The position will be responsible for supporting Cleaning Validations in the Purification/Cell Culture areas for the large scale production of clinical and commercial products. This work includes:

    • Developing Cleaning Validation sample plans, worksheets and summary reports.
    • Reviewing the Cleaning Validation worksheets, equipment use logs, manufacturing batch reports and QC test results.
    • Authoring deviations and assisting in resolutions
    • Performing Periodic Reviews of validated equipment which entails review of change records for validation impact through the TrackWise system, and review of data trends and validation lifecycle documents.
       

     Qualifications:

    • Bachelor’s degree or higher in a Chemical, Biochemical, Mechanical Engineering or Science discipline.
    • 3+ years of relevant experience.
    • Detailed knowledge of cleaning validation and sampling techniques (rinse water and visual inspection), particularly in Purification is highly desired.
    • Experience in a GMP regulated environment and a high level understanding of biopharmaceutical processes. 
    • Demonstrated capability to use quality systems and processes such as change control and discrepancy / deviation processes. 
    • Passion for customer service to the diverse cGMP manufacturing customers and quality organization.
    • Knowledge and application of basic validation and risk management theories, principles and techniques used in biopharmaceutical manufacturing.
    • Highly self-motivated, excellent organization and communication skills.
    • Willingness and ability to work independently and as part of a multi-disciplinary team.
       

    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.