Job Search

The internship projects will focus on innovation in the therapy area ophthalmology. The diseases of interest are age-related macular degeneration, diabetic retinopathy and diabetic macular edema. The key topic of interest is application of artificial intelligence and innovative digital health monitoring tools in predictive diagnostics and personalized healthcare. Both summer interns will conduct a literature review of peer-reviewed and non-peer reviewed manuscripts and reports, summarize the findings and develop a 45 minute presentations to the internal clinical science, innovation and personalized healthcare teams. Each of them will also work to write a review paper to describe the main findings from the literature review.

 

Scientific mindset and independent work required. Teamwork and collaboration is key. Interest in exploring and developing applications of artificial intelligence and innovative digital health monitoring tools in predictive diagnostics and personalized healthcare.

Length: 6 months

Start Date: TBD

Description:

"Curation R Framework" is aimed at building out an in-house data transformation framework based on R packages in order to help data curators clean up and map clinical trial data to standards so that further analysis can be done by data integrators and scientists. In phase 1 the focus of the work will be on reviewing already developed R packages, performing unit testing and adding catch-error programming. In phase 2 the plan is to enhance the framework by developing new functionality as well as Continuous Integration (CI) / continuous delivery (CD) workflow.

Responsibilities:

• Understand business drivers and processes as it relates to software development
• Understand what it takes to write software that is used by others and enjoy sharing what you know in a way that you can move on to another interesting project and there are no surprises for the team
• Enjoy whiteboarding the future, collaborating, learning from or teaching others so we can all become better developers
• Curious and interested in developing your skills
• Translate business requirements into maintainable software components and understand impact (technical and business)
• Adhere to high quality software development lifecycle (e.g., Agile, Waterfall)
• Support solutions through monitoring, response to service problems, defect resolution, configuring software, root cause analysis and preventive actions
• Participate in service capacity planning and software performance analysis, tuning
• Contribute, review and influence on-going design, architecture, integration (e.g. API) standards and methodology for software development
• Apply current technology, tools and techniques according to established standard practices
• Development of operating procedures and training of support organizations
• Provide work estimates, identify risks and dependencies for new systems, implementation plans for enhancements, defect fixes

Qualifications:

An experienced CS professional with a strong background in R development.

• Experience with R packages commonly used for data munging and visualization (dplyr, ggplot2, plotly, etc.) and R idioms for software development (e.g., Tidyverse, Bioconductor)
• Experience with R web development (R/Shiny, Shiny Module, shinydashboard, HTML, CSS, Javascript)
• Proficiency in R programming including documented experience with package development according to best practices
• Experience contributing to open source projects, including R packages
• Experience performing unit testing and ability to test code developed by others
• Basic shell scripting skills, experience with version control (git)
• Experience with Continuous Integration / Continuous Deployment (CI/CD) tools
• Have been an active member of software engineering teams (Scrum/Agile preferred)
• Have exceptional communication skills, fluent in English, have the ability to directly communicate with research scientists and understand business requirements for scientific applications
• Have experience collaborating cross-functionally on small to large and complex efforts

Education:

Bachelor’s degree or higher in Computer Science, Bioinformatics, Biology or related field

SUMMARY OF JOB RESPONSIBILITIES

The Associate Director Records and Information Governance and Operations sets the vision and leads the records and information management program in Genentech’s Coremap Group (GCG). The Associate Director is a strategist, thought leader, and authority who establishes governance and oversees operations necessary to manage Genentech’s information assets. 

Key responsibilities for this role include policy, compliance, training, and operations.

Specific responsibilities include:

• Being a thought leader on managing information and evolving the Genentech records and information management program
• Developing and implementing records and information policies, procedures, and retention schedules, and contributing to the development of a global classification
• Designing and promoting policies and practices to protect data and information assets and vital records
• Managing  vendors and budgets for outside services for records and information operations such as offsite records storage, scanning and indexing services, etc.
• Designing and leading a records and information assessment program to evaluate compliance, overseeing regular assessments of the program, and monitoring program effectiveness utilizing benchmarks
• Establishing standards and workflows for transferring electronic and paper records and information due to internal reorganizations, mergers, acquisitions, or divestitures and overseeing the transfer of records
• Identifying content to include in records and information training and communications and maintaining education program content
• Establishing and maintaining standards on long term storage formats of electronic information
• Representing department on internal committees as needed
• Championing the Records and Information program to management and local and global stakeholders to heighten their awareness, understand business needs,  and garner support for initiatives
• Setting  team objectives so that employees are clear on their roles and responsibilities
• Actively investing time to get to know his/her employees, including understanding what motivates them to perform at their best

REQUIREMENTS:

Education and Experience

• Candidates must have a Bachelor’s degree (information science background is preferred); graduate degree in information science or  computer science is preferred
• 7-10+ years of records and information management and governance experience in a corporate setting
• 7+ years of leadership experience in records management, preferably within a life sciences business
• 5+ years of experience as an effective manager is required.

Skills and Knowledge

• Demonstrated experience resolving challenging records management issues and proven ability to deliver sound, clear, practical advice in a corporate business setting
• Exceptional problem solving skills and ability to formulate innovative solutions that demonstrate both strategic and tactical thinking
• Outstanding ability to organize, prioritize, and execute programs
• Strong leadership and motivational skills with demonstrated ability to lead and influence effectively in a matrix environment
• Ability to understand the organizational culture, to build coalitions at all internal and external levels
• Proven experience in leading organizational change
• Proven experience in staff management, coaching and career development
• Excellent judgment and interpersonal skills, consensus and relationship building
• Outstanding communication skills, both verbal and written
• Understanding of regulatory, legal, privacy, security, technology, and market trends that impact records and information management
• Ability to work with IT to understand technology related to records management and to convey records management requirements to IT
• Project management experience, familiarity with validated systems and testing a plus
• Experience with data mapping and migration

Certificates, Licenses, Registrations Preferred

• Information Governance Professional (IGP) Certification highly preferred
• Certified Records Manager (CRM) ICRM
• Certified Information Privacy Professional (CIPP) (IAPP)
• Electronic Records Management Master (ERMm) (AIIM)
• Enterprise Content Management Master (ECMm) (AIIM)

Travel

• Ability to travel nationally, and limited international trips

Performs electrical or mechanical troubleshooting to determine problems in non-functioning electro-mechanical equipment used in the manufacturing process. Dismantles, adjusts, repairs and assembles equipment according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings. Uses test and diagnostic equipment to perform checkouts. Rebuilds manufacturing equipment as required. May perform equipment modifications as directed by manufacturing engineers.  

Genentech’s South San Francisco Production (SSFP) group manufactures medicines that improve the lives of patients around the world.  SSFP is the first cGMP production site established by Genentech and includes facilities, equipment, and staffing to perform end-to-end manufacturing that is scheduled and supported 24 x 7. SSFP currently has opportunities available for experienced Utility Operators to join the day shift.

These positions operate utility systems and subsystems in an FDA regulated environment to ensure:

• Monitor work order queue and ensure all leak repairs to Utility Systems are performed in a timely manner
• Troubleshoot and repair leaks on Utility systems (pump mechanical seals, valves, etc.) and mechanical piping systems
• Equipment remains in its designed cGMP and/or validated state at all times
• All equipment operation is in accordance with federal, state, local and company regulations, procedures and policies

Responsibilities include:

• Manage the day to day operation of plant utility systems; monitor the overall operation and status of the utility systems and complete work orders for system repairs as needed
• Ensure/maintain all utility equipment areas in a constant state of inspection readiness
• Continuously evaluate the operation of all utility systems and utility subsystems; identify specific process improvement needs and provide recommendations for system upgrades
• Identify training deficiencies, provide recommendations for training and provide training as needed
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability
• Provide operational support to Facility Services, Engineering, Manufacturing, and Research and Development
• Perform Confined Space Entry on an as needed basis
• Complete maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines
• Gather and document appropriate information associated with a System Discrepancy (an event in manufacturing process and/or support system that is outside approved operating parameters or approved procedures)
• Work with various chemicals, steam, pressurized gases/liquids of various temperatures
• Work in close proximity to moving equipment
• Act as point of contact for customer guidance and support
• Perform troubleshooting for all Utility equipment that is directly impacting manufacturing processes
• Attend all required cGMP and Safety training

Requirements

We are seeking local applicants who possess the following qualifications. The level of the position will depend on the qualifications of the selected candidate.

• High School diploma or equivalent. Technical degree, certificate, or coursework a plus
• Completion of technical school, accredited 2 year program or applicable work history (OJT) in the field
• 5+ years of experience in an industrial / manufacturing maintenance role with demonstrated strong mechanical aptitude; 8+ years required for the Specialist level
• Ability to respond to, evaluate and resolve a variety of situations involving mechanical, electrical and systems controls
• Ability to troubleshoot and repair leaks on water systems (pump mechanical seals, valves) and mechanical piping systems
• Practical knowledge of equipment maintenance, operation, control and cleaning for process equipment; HVAC/R; clean utility systems; process air systems; waste neutralization systems; bulk chemical and gas systems; RW/Glycol Systems is required for the Specialist level
• Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range is also required for the Specialist level
• Ability to perform maintenance and equipment servicing according to Standard Operating Procedures
• Effective verbal and written communication skills including the ability to prepare technical reports and the ability to read and understand Standard Operating Procedures (SOPs)
• General knowledge of shop tool operation and safety
• Detail oriented with the ability to demonstrate good record keeping practices
• Ability to understand and adhere to federal, state, local and company regulations, procedures, and policies
• Computer skills with the ability to use word processing, spreadsheet, database, ERP and email applications
• Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery
• Strong interpersonal skills with the ability to work effectively as part of a team
• Ability to work with minimum or no supervision.
• Flexibility to work overtime or a temporarily modified

*Only local candidates are being considered

At Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are courageous in both decision and action. And we believe that good business means a better world. We are looking for an experienced and innovative Enterprise Architect (EA) and leader to work in our Global Enterprise Architecture Team to develop and maintain Identity & Access Management (IAM) strategies, engaging with a wide range of partners to guide them in making the right investments in technology and innovation. In this role you provide technology strategy and architecture leadership and direction to the Roche Group worldwide. You ensure that IAM technologies and standards are used and applied to enable strong and seamless identity-based security in support of Roche’s business strategies and processes.

Your main responsibilities will be:

• Deliver clear value-based technology strategies and roadmaps to support our IT Business Partners to dedicatedly respond to digital transformation and disruption.
• Provide insights and input for better decision-making to help build the capabilities required by our IT Partners and consumers of our services.
• Lead and encourage the technology transformation from roadmap to realization by conducting assessments, innovation and prioritizing standards.
• Assess technologies and trends in a methodical way to ensure insights based recommendations that fit the Roche environment. Analyze current technology environment to identify deficiencies and recommending solutions, as well as staying abreast of emerging security technologies and trends and apply them where appropriate
• Facilitate engagement and foster collaboration with architecture partners to ensure consistency in direction and decision-making.

Furthermore, you will:

• Create compelling presentations to articulate the technical strategies, architecture and roadmaps to various levels in the organization
• Work with Information Security group and CISO to define the strategies and principles that guide technology decisions and trade-offs for the enterprise
• Consult on technical architecture implementation activities with all partners and Solution Owners to ensure alignment. Handle and work with Engineering on the evaluation and selection of IAM related technologies and products
• Identify the organizational, operational sustainability and financial impacts of defined strategies; analyze gaps to create a risk profile for the proposed strategy

We believe to be successful in this position you'll need:

• A Bachelor's degree in computer science or equivalent experience and CISSP, CISM, CISA certified (desired). Ideally, you have deep business knowledge in the Pharma/Biotech industry and associated processes and you bring the following qualifications:
• 10 to 15 years of experience in IAM and IT security with medium to large global enterprises with global geographical topologies
• Good understanding of IAM technology domains such as access and authorization controls, IDaaS (especially in the space of Consumer Identity Management), Identity Virtualization, Identity Federation, Directory Service capabilities, Privileged Access Management, external identity management, single sign-in, PKI Infrastructure
• Solid experience with simplification, harmonization and automation of IAM across applications, devices, technology components and platforms. Use an agile and adaptive identity ecosystem to ensure consistent, role-based, context-based access and consistent/automated identity lifecycle management processes
• Accomplished in framing an enterprise IT architecture, confirmed to deliver robust, secure, scalable, highly available, and dynamic solutions to drive global business objectives

What else should be in your toolbox?

• You have the ability to review proposed solution architectures, identify risks and provide remediation recommendations in line with established standards and overall IAM strategies
• Effectively engage partners at all levels and promote candid communication in the creation of strategies and roadmaps; able to influence and negotiate with business and IT Partners.
• Be active and influencing in your area of expertise; able to act fast and make quick decisions while taking smart risks. You enjoy challenges, think in opportunities and solutions, not only in threats
• You are constantly looking for innovative ways to do things and opportunities for improvement. You are able to live in ambiguity and react positively in constantly changing business environments
• Understand the critical importance of diversity and take advantage to build stronger strategies. You will be an extraordinary collaborator
• Excellent English communication skills and understanding of what information is required by whom, when and how

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

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

#LI-CGMT1

Genentech is seeking multiple interns either pursuing, or recent graduates from a MSc/PhD degree with expertise in advanced analytics to help us explore its potential applications in healthcare. The specific intern will work with the biostatistic function in product development organization in Roche. We propose to evaluate and implement a Bayesian dynamic borrowing approach to construct a hybrid control arms for ongoing and future clinical trials. This work will involve data types beyond randomized clinical trial data, including the clinical trials data and Flatiron datamart (RWD). The primary goal of the project is to provide ready to use tool and guideline for current and future clinical trials.

Qualifications

• Excellent R/Stan/Jags skill

• Solid Bayesian statistics knowledge

• Sufficient clinical trial design knowledge

• R package and shiny app development skill as a plus

Main Purpose of the Position:

This position is part of Genentech’s’ Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon.  iNeST is a next generation immunotherapy for the treatment of patients with cancer on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting and novel technology.

Materials Specialist / Technician III / Technician II are responsible for the execution of product logistics in a cGMP environment.  This includes the receipt and inspection, storage, wipe down and issuance of kitted and non-kitted GMP materials used in production and final product shipping/distribution to our customers.  Other responsibilities included performing data entry into various business systems and databases ensuring department compliance with policies and procedures.

 

Responsibilities:

• Perform all work activities in a safe and compliant manner according to all Genentech policies, procedures and trainings
• Receive, identify, quarantine, store, handle, dispense, release, and issue raw materials, starting materials, intermediates, reagents, labels, GMP supplies and packaging materials.
• Assist with maintaining an accurate inventory (paper and electronic), expiration, and retest records for all GMP materials.
• Coordinate disposition of all expired materials and maintain applicable documentation.
• Participate in internal GMP inspections when needed
• Proficient in both DOT & IATA shipments, including applicable certifications.
• Interface with a variety of departments when coordinating shipping and receiving.
• Maintain appropriate training for import/export shipping and receiving. Proficient in associated documentation for all import/export activities.
• Maintain general supplies, orders and re-stock GMP areas as required.

• Preform and assist with deviations, change control, and corrective / preventive actions within the established Quality management system

• Ability to create and revise standard operating (SOP) reverent to department processes
• Access various business systems and input data with a high level of accuracy (i.e. decommissioning of materials, material destruction, plant to plant movements, and other non-routine ERP transactions)
• Record creation, collection and storage per corporate retention schedules
• Perform department related project activity that may include investigating, analyzing, formulating possible solutions, documenting processes, and communicating results
• Schedules transportation for outgoing shipments for inbound and outbound operations
• Using manual labor, pallet jacks, and forklifts, move product and both GMP and non-GMP supplies to and from storage locations and delivery trucks
• Assorted additional duties as assigned.

Qualifications / Requirements:

• BA or BS degree in Business Administration or related fields is preferred
• Materials Technician II = 4-5 years, III = 5-6 years, Specialist = 7+ years of experience.
• Ability to follow detailed verbal and written instruction
• Good basic mathematical skills
• Ability to repeatedly lift 50 lbs
• Proficiency with PC desktop applications and business operations software system
• Ability to lead, coach, and influence in a highly cooperative and dynamic environment
• Flexibility in assignments and able to work over-time, holidays, weekends and different shifts as required to meet business and customer needs
• Strong organizational, communication and interpersonal skills
• Valid driver’s license with acceptable driving record (if applicable)
• Experience and proven abilities to analytically investigate and troubleshoot system issues and drive the implementation of solutions.
• Demonstrated ability to plan, prioritize, and execute work appropriately with minimal supervision
• Experience in Quality management systems working on deviations, change control, and corrective / preventive actions
• Experience in Lean methodologies
• Experience with cell therapy manufacturing is preferred
• Experience in personalized health care environment preferred

The People Analytics team at Genentech is a small group of 9 people that has an outsized impact.  We build products around data whose insights affect all ~14,000 Genentech employees.  Our team is close knit and dynamic acting more like a startup within Genentech than anything else.  We are looking for a dynamic Senior Data Scientist to join our team to help propel our trajectory and drive more impact.

The McCarthy postdoc group at SSF will focus on developing and implementing analytical and experimental strategies that maximise the value of human genetics for drug discovery and precision medicine. The research will build upon work undertaken in Dr McCarthy’s academic research program at Oxford. One major area of research interest will continue to revolve around the prioritization and functional characterization of therapeutic targets -- for example, through implementing strategies for connecting regulatory variants to their downstream targets, and the high throughput perturbation of those targets in suitable cellular systems. A second strand will involve the use of global and partitioned risk scores to stratify risk, and to capture etiological and clinical heterogeneity, and the translational application of those scores. The group will continue to develop and apply these approaches in the area of metabolic disease (in part through continued interaction with academic researchers in genetic and functional consortia), but will also seek to implement analogous approaches across the wider range of diseases of interest to Genentech. 

The successful candidate will have a PhD and/or MD from a highly reputable institution, with training in either the life sciences (biology, medicine etc) or computational sciences (maths, physics, computational science, bioinformatics etc), but with proficiency and experience that spans both. As well as a strong publication record, they will have excellent communication skills, and interest in exploiting the potential of human genetics to gain fundamental insights into the biology of disease. Postdocs in our lab work in a challenging and stimulating yet supportive and interactive environment, becoming independent scientists with the ability to lead their own research groups.

For more information about the postdoc program: https://www.gene.com/careers/university-and-early-career/postdocs

A Postdoctoral Research Fellow position is available immediately in Genentech’s Oncology Biomarker Department in the group of Mahesh Yadav to work on projects related to cancer immunotherapy. 

This is unique and rare opportunity for a post-doctoral fellow with a strong computational background to work with large biomarker data sets from Roche/Genentech’s cancer immunotherapy trials to gain new mechanistic insights into neoantigen-driven immune responses in human cancers and (Yadav et al, Nature 2014, Fehlings et al, JITC 2019). The goal will be to apply these findings in improving neoantigen specific therapies and also publish findings in top tier scientific journals. The position will have plenty of opportunities to interact and collaborate with scientists in a dynamic cancer immunotherapy community at Genentech (South San Francisco campus). 


Qualifications:

• Applicants must have a recent doctoral degree with strong computational expertise and a robust understanding in some area of biology. Preference is given for experience in immunology, oncology, genetics, or systems biology,
• The successful applicant will have a demonstrated record of innovative scientific accomplishments as evidenced by at least one first-author paper published or accepted in a top tier journal.
• Proficiency in programming using scripting languages (Perl/Python), R, and experience in standard bioinformatics toolkits and programs.
• Collaborate extensively with multi-functional teams to leverage cutting-edge technologies and expertise both internally and externally. Attend and present at international meetings and author manuscripts for publications in top-tier journals.
• Immuno-oncology PhD candidates with strong computational expertise are strongly encouraged to apply. 

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 large 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. 

Interested applicants should send their CV, a cover letter describing your research interests and a list of 3 references.

#LI-GREDGL1

The Position

Position Summary:

Personalized Healthcare (PHC) creates opportunities to improve outcomes for patients today and in the future. The Product Development Personalized Healthcare (PDP) function aims to drive Roche enterprise transformation across the Pharma value chain by

• Accessing meaningful data at scale (high-dimensionality datasets with longitudinal clinical trial data, real-world data, whole genome sequencing, transcriptomics, immune system profiling, anatomic and pathology imaging data, and digital health data)
• Applying advanced analytics to accelerate insight generation
• Feeding forward insights re: disease activity/disease characterization to inform research and development decisions which improves our internal productivity and provides evidence to inform external decision-makers including patients, healthcare providers, governments, regulators and public and private payers.

As a Business Operations Leader (BOL) you will report to and work in close partnership with the Head of the Business Management Office. You will be working in a hybrid role -- part Project Management and Business Process Management attuned to the emerging functional needs. In all cases, we look to you to provide strategic counsel in the form of thoughtful input and insights, foster a collaborative team environment that excels at leveraging diversity of thinking and expertise, apply design-thinking to challenges encountered, and disciplined delivery to project/operational assignments. You will help define and operate functional solutions to achieve PDP value delivery and business objectives.

Primary Accountabilities and Responsibilities

Business Manager to guide leadership team, committee, network or other forum decision-making and achievement of shared business objectives set by senior managers and executives.

• Thoughtful planning: Gather and analyze data and solicit senior management input to determine what is needed and desired; Leverage “SMART” goal setting; Implement strong project management of critical path activities to set teams up for success to achieve near-term and long-term objectives; Design, prepare for and effectively facilitate team meetings and/or interactions (agenda setting and outcomes and action item management)
• Decision-making: Introduces fit-for-purpose decision-making framework appropriate for the urgency, complexity of business context; Eliminates obstacles to decision making
• Relationship Building: Builds and maintain positive, trust-based working relationships with key stakeholders; Partner with colleagues to design required solutions to address identified gaps and emergent business needs
• Communications: Design and implement communication plans targeting relevant individuals in the organization – individual contributors, management/sponsors and external stakeholders
• Continuous Learning & Improvement: Promotes organizational learning from risk taking; Fosters supportive environment to achieve change imperative; Builds in a feedback loops to monitor leadership team/committee/network or forum “health” and take steps to improve interaction/dynamics

Act as lead for functional operations lead and/or project manager for functional capability development or improvement projects

• Needs Assessment: Gather data and solicit senior management input to determine what is needed for functional and portfolio-enabling operations
• Solution/Project Definition: Partners with the function’s Leadership Team to align on scope and desired outcomes for projects and/or functional performance objectives
• Leadership: Lead coordinated, thoughtful, fit-for-purpose solutions for both operations and projects; Facilitate, influence teams and individuals to advance the business to achieve stated objectives; Actively shape business process or technology solutions & strategies to improve the likelihood of successful embedding into and acceptance by the organization
• Goal/Value Tracking: Has system awareness of what drives value for Pharma; Leads thoughtful planning, tracking and communication of functional/non-molecule specific goals to ensure transparency and business impact.
• Agility: Incite and inspire others to seek sustainable and innovative solutions and alternatives; Continuously integrate organizational priorities and challenges into planning and execution of functional solutions/service delivery; Flexibly adapt operations, project delivery and advisory services with the needs of the business

Skills/Abilities:

• Business excellence: Possesses system awareness of what drives value for Pharma in order to appropriately prioritize competing business needs; Develops efficient processes/approaches for the team based on business knowledge and proactive collaboration with others to get things done
• Collaboration: Applies curiosity and practices continuous learning to effectively collaborate within and across multiple organizations and with stakeholders of various background and skill sets; Skilled in creating a respectful and collaborative team/group environment that pursues truth and effective performance; Contributes actively to group learning from both success and failures
• Communication: Able to simplify a complex set of components into a simple, effective message; Proactively determines communication needs and implements change messaging and reinforcement interventions; Possesses strong executive presentation skills and writing skills
• Initiative: Able to define priorities and focus on areas that add value; Self-motivated and disciplined to deliver results; Asks for feedback to continuously improve own work and that of the group; Finds ways to scale their assignments to make space for growth opportunities
• Influencing: Demonstrated skills in persuading senior leadership on strategy, initiatives implementation and decision-making; Possesses a strong self-awareness to influence in varied situations and with various levels in the organization to achieve business objectives; Has a track record of achieving outcomes that advance the business
• Problem solver: Knows how to apply design thinking and problem solving frameworks; Demonstrates an ability to work in unstructured and ambiguous environments; Demonstrate ability to develop and present sound proposals and recommendations; Brings experience in implementing and embedding solutions, not just information-gathering to management.
• Leadership: Understands the impact of own actions to the business; Takes full accountability for their work; Speaks up and volunteers to lead new work scope to support team and function effectiveness; Role models Roche Leadership Commitments and Product Development Behaviors

Qualifications:

Business Operations Leader

• Advanced degree preferred in business, life sciences, or related disciplines
• 10+ years in multi-disciplinary experience in the pharmaceutical/biotechnology academia/industry
• 5+ years proven availability to lead large-scale, complex projects –programs in a fast paced dynamic and matrix environment
• Significant experience in transforming and successfully introducing change
• Large-scale budget management
• Ability to travel internationally as needed, less than 10%

#LI-PDHB2

We are seeking a postdoctoral fellow to work on mechanisms of TGFb-beta activation who would be co-mentored between the Townsend and Arron laboratories. This position would leverage a suite of unique reagents that selectively target TGF-beta isoforms, crystal structures, and conditional KO mice, and also study genetic associations with TGF-beta in observed from whole genome sequencing of patients enrolled in Genentech clinical trials.

Genentech has a proud tradition of world-class basic and translational research, and the postdoctoral program here allows for important questions about fundamental biological mechanisms to be addressed independently of drug development programs. The large clinical trials conducted by the Roche group gives us unprecedented access to highly clinically characterized patients with matching data on treatment outcome, genetic variants, and disease state. A postdoc will be able to leverage these resources and study biological pathways of interest aided by world class scientific infrastructure, and also gain exposure to the drug development process.

Qualifications: The successful candidate will be a recent or pending Ph.D. graduate with a background in Immunology, Biochemistry and/or Cytokine biology. They will also have demonstrated ability to conduct high quality research through publications in top tier peer reviewed scientific journals.


https://www.gene.com/scientists/our-scientists/michael-townsend

https://www.gene.com/scientists/our-scientists/joe-arron

 

The Quality System Implementation Technical Manager will be a member of the PTD South San Francisco Device Development Business Operations Group.  This group plays a key role within the PTD South San Francisco Device Development organization to implement and maintain processes and systems to sustain a quality mindset and compliance that enables for filing and inspection-readiness.  The group is responsible for Quality System support including electronic systems implementation and maintenance, training management, knowledge management, new and existing regulation and requirements implementation, purchasing controls support, discrepancy and change management monitoring, Design History File record management, and audit/inspection WAR room and Front Room facilitation.

Responsibilities: 

• Develop solid expertise with global, company-wide Pharmaceutical Quality System (PQS) requirements and business processes to apply to design, development, industrialization and commercialization, for medical devices and combination products. 

• Facilitate implementation of new and modified quality system requirements including but not limited to processes, SOPs, templates and guidance documents 

• Implement processes for managing changes and discrepancies encountered by device development project teams to enable compliance of requirements and consistent documentation. 

• Assist with design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes. 

• Assist with the development of remediation plans in response to internal quality assessments/audits, regulatory inspections and notified body interactions. Aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions. 

• Use local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices. 

• Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards and DHF regulations. 

• Participate in Continuous Improvement efforts to assess how existing Knowledge Management (KM) practices and tools can result in quicker and better accessibility of information for device teams with a focus on the processes (“the how”) to support Quality Systems.

• Maintain local procedures associated with lab operations GMP records management and training.

• Manage the departments non-regulated and regulated IT systems such as audit trail software system, electronic notebook system, requirements management system, and knowledge management repositories.

• Manage subscriptions to professional network associations and global Information providers such as AAMI, PDA, and HIS.

Experience: 

• B.S degree or equivalent; preference for engineering or technical field 

• 5 - 7 years experience in medical device or combination product design and development environment with emphasis on design control 

• Knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to device development. Understanding of international regulations and standards is a plus. 

• Knowledge & expertise in applying Combination Products GMP rule is desired 

• Knowledge & expertise in Quality System Procedure development, implementation and training 

• Knowledge & expertise in Change Management, Discrepancy Management, Complaint Handling and CAPA

• Knowledge & expertise in Document Control, Records Management, Data Integrity

• Knowledge & expertise in Laboratory Controls and Design Verification & Validation Testing

• Strong project management and organizational skills 

• Strong interpersonal, verbal, and written communications skill 

The Senior QC Analyst will perform environmental/utility monitoring as well as microbiological testing of biopharmaceutical material at various stages of production, microbial identification, as well as assay validations/studies. Responsibilities for the role include the following:

Job Responsibilities General 

• 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 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 
• Ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents
• Perform any other tasks as requested by Management to support Quality activities 
• Actively participate in group and project teamwork
• Prepare and maintain reagents per established procedures

Lab Tasks 

• 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 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

Multiple positions available across two work schedules. Monday to Friday, 5x8 OR Wednesday-Saturday, 4x10. Shift to be determined by the team.

Please note this is a Day Shift position, Thursday through Saturday (every other Wed), 6:00am to 6:30pm.

Main Purpose of the Position:

Under the direction of Manufacturing Supervisor or other qualified Operations Specialist, perform a wide variety of tasks and operations that are required to formulate, fill, and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. Troubleshoot, maintain, assemble, install, and repair all electronic, mechanical, and instrumentation devices on production equipment as required.  Assist on major equipment overhauls, repairs, and installations as necessary.   All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.

In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:

• Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
• Embraces Class A principles and behaviors.
• Continuously in search of ways to maintain the highest levels of productivity.
• Actively participates in a teamwork environment that maintains a high performance culture.

Responsibilities:

• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Perform safety and housekeeping audits as required.
• Set up, change over, and test run equipment for various-sized vials and packages as required.
• Make mechanical and electrical adjustments necessary for the correct operation of the equipment.
• Act as a troubleshooter, moving between all areas to assist related crafts in the performance of their duties.  Diagnose problems involving electronic, electrical, instrumentation, and pneumatic hydraulic control systems. Work with the maintenance department and/or outside services to repair, maintain, and calibrate these systems as required.
• Perform or coordinate major and minor overhauls of production equipment as needed.
• Perform training of other Operations Specialists.
• Assist in the development of plant SOP's and training materials.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
• Assist and/or operate all sterile filling and final vial packaging equipment in the plant. Perform material handling in the plant as required.
• Perform preparation of sterile components.
• Assist in the cleaning, set-up, sterilization, and performance of maintenance on a variety of processing equipment.
• Perform bulk thaw, dilution, and formulation operations.
• Conduct environmental monitoring activities in the manufacturing areas as required.
• Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high­ quality output.
• Perform cleaning and housekeeping duties as required.

Qualifications / Requirements:

Proficiency in the English language - reading, writing, and communication.  Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended period of time. In addition, all candidates must pass a vision acuity and color discrimination test.

Education:

• High school diploma or equivalent.
• Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) is highly desirable.

Experience:

Five years recent (within the last 7 years) experience in the set-up, repair and operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers. This experience must include equipment set-up, changeover, mechanical/electrical repairs, disassembly, and preventative maintenance. Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.

Special Skills or Abilities:

Ability to read Piping and Instrument Diagrams, electrical drawings, blueprints, PLC ladder logic, etc. Ability to analyze instrumentation and electronic maintenance problems and take appropriate corrective measures. Knowledge of electrical, hydraulic, and pneumatic principles.

Computers:

Must be computer literate, including ability to interface with computer systems and PLC-based logic. Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail.  Must possess basic typing skills.

Mission

As a Data & Analytics Specialist, you will work closely with multi-disciplinary teams to solve complex data problems enabling PD to transform data into actionable insights. You will partner with IT and business stakeholders to co-create data and analytics enabled solutions that help our teams fulfill our mission: to do now what patients need next.

Reporting to the Head of Talent Acquisition for Genentech, the Director of Talent Acquisition for Commercial, Medical Affairs, and Government Affairs (CMG) will lead the development and delivery of the recruitment strategies for the overall commercial organization for Genentech.  S/he will directly manage a diverse team of Talent Partners who are responsible for meeting the short and long-term recruitment needs of the organization. The Director of CMG Talent Acquisition will also serve as a member of the Talent Acquisition Leadership Team, the leadership body responsible for developing the overall staffing strategy for the region as well as leading the Genentech TA function.

As the leader of the function, the successful candidate will be expected to:

• Provide strategic leadership for CMG recruitment initiatives

• Develop and drive flexible, multi-faceted hiring strategies that leverage internal and external talent channels

• Lead, engage and inspire an experienced, high-performing, geographically dispersed team of seasoned recruiting professionals

• Provide in-depth forecasting of future requisition projections and recruitment capacity needs 

• Demonstrate strong enterprise mindset and desire to collaborate with colleagues across Genentech

• Build and maintain cross-functional relationships throughout the local HR community

• Identify opportunities for greater efficiency and adjust programs and processes accordingly 

• Approach barriers from problem-solving standpoint with the goal of creating win-win outcomes 

• Lead courageously and make strong and informed decisions

• Demonstrate self-awareness and willingness to grow and develop

• Foster an environment of inclusion and collaboration

Qualifications

• Minimum of 10-12 years of Staffing and/or HR experience and 3-5 years of management experience, preferably within drug discovery, biotech or technology setting

• Experience leading team within large, complex organization during periods of significant change 

• Theoretical and practical knowledge of various staffing/workforce planning models and proven record of implementation

• Demonstrated ability to design and deliver effective recruiting strategies that maximize diverse talent channels

• A forward thinking and proactive leader with collaborative focus who can effectively partner with colleagues across global organization

• Exceptional people management and leadership skills

• Demonstrated ability to make informed decisions that have broad impact

• Strong customer service skills and consultative approach when dealing with internal and external clients

• Excellent organization and project management skills

• Superior communication (written, verbal and presentation) and influencing skills

Education

• B.S. degree or equivalent work experience. Advanced degree is preferred, but not required.

#LI-CGMT1

Main Tasks & Responsibilities:

- Carries out day to day routine repair/maintenance instrument work. 日常儀器維護和維修工作。

- Installs equipment at customer's facility to ensure full functionality according to specifications. 在客戶便利時安裝儀器，確保依據說明書實現所有功能。

- Sales of Service Contracts. 勞務收入契約。

- Coordinates problem resolution with engineering, customer service, and other personnel to expedite repairs. 協同工程部，客戶服務及其他人員解決問題，加快維修進度。

- Maintains records of performance reports. 維護服務報告記錄。

- Develops service handbooks and bulletins based on field investigations, engineering changes, and overall knowledge of product. 通過現場調查，工程變化和整體產品知識創造服務手冊和報告。

- Develops and conducts training on the safe operations of the equipment and demonstrates skills to trainees, including team members, customers as well as distributors. 對員工，客戶及經銷商進行安全操作儀器的培訓和技巧的展示。

- Assists in the yearly budget exercise for Technical Service. 協助技術服務部的年度預算。

- Management of spare parts 零配件的管理。

- Interact with customers to resolve product or service problems by clarifying the customer's inquiry and complaints. 透過澄清客戶的詢問與投訴，與客戶互動以解決產品或服務之問題。

- Reporting and communicating problems with global service center of respective BA to determine the cause of the problem; expediting correction or adjustment; following up to ensure resolution and execution of required corrective actions. 與各BA之全球服務中心匯報及溝通問題，以確認問題原因、加快更正或調整，及後續追蹤以確認必要之糾正措施的決定和執行。

Job location 工作地點

North of Taiwan 台灣北部



Education 教育背景 :

Minimum qualification required is diploma in Electronic Engineering, Mechanical Engineering or Biomedical Engineering. 電子電機, 機械, 或醫工大專及以上學歷



Specific Knowledge & Skills 專業知識與技能 :

1. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 解決實踐操作問題及各種突發事件。

2. Able to handle computer Operating System such as Window NT and DOS.熟練操作電腦

3. Fluent in Mandarin is a must

Sr. Learning Technologist

The general purpose of this role is to research, develop and deliver the most effective and efficient distance learning and learning technology solutions to meet CMG training objectives and meet the needs of tomorrow’s learner. This role is part of the centralized CMG Training and Development Learning Design and Technologies (LD&T) team and will work closely with fellow team members and internal/external stakeholders.

We’re seeking an individual with a keen interest in emerging technologies to help us transform the way we deliver learning to our people. Must demonstrate a strong breadth and depth of skill in working with technology for learning, both digital and face to face.

Key Accountabilities:

Responsible for research & development, prototyping, piloting and embedding new technologies into our internal learning ecosystem, including production of any process documentation for its adoption. Demonstrate an innovative and creative approach to learning design and provide options for how to digitalize existing learning initiatives. Work with instructional designers to align on design approaches and collaboratively develop transformative learning solutions. Build relationships with 3rd party vendors and actively explore their platforms and tools to validate their value based on our learner solution needs. Act as an expert advisor, educating colleagues on emerging technologies as well as the best use of our current LD&T offerings, investing time to share your findings and expertise, and to help drive and develop a digital mindset. Analyze and interpret learning technology needs across CMG Training & Development and work with stakeholders across functions to understand current capabilities and areas for improvement. Proactively incorporate LD&T’s capabilities and offerings into other CMG Training & Development strategies, plans and programs. Support the LD&T function in implementing long-range visions for future initiatives, strategies, objectives and plans to optimize learning and development support to CMG. Complete all compliance training requirements. Reinforce with team the importance of adhering to compliance policies. Raise questions proactively and seek advice as needed.

At the Sr. level:

Incumbents in the Sr. Learning Technologist role are expected to demonstrate a higher level of leadership, impact and experience than that of a Learning Technologist. They are expected to:

• Assist with onboarding new team members and consistently mentor CMG Training & Development employees.
• Be involved in higher-level stakeholder management.
• Utilize expertise and experience to support Genentech stakeholders.
• Direct and manage performance of junior colleagues and/or serve as a point of escalation.
• Act as internal subject matter experts in Learning Technologies who understand and represent the long-term vision for the area.
• Provide ongoing leadership of projects and processes including management of complex matters.

Key Competencies:

Achieving Results

• Is goal-directed, persistent; driven to achieve objectives
• Holds self and others accountable for results
• Aligns behaviors to support the goals

Communication

• Reads verbal and non-verbal cues of others
• Uses appropriate methods or approaches to communicate with others
• Keeps others informed

Decision Making

• Thinks through problems clearly and logically
• Gathers information necessary to make decisions
• Makes decisions even when all information is not known

Teamwork and Collaboration

• Cooperates and supports colleagues to be successful
• Provides and solicits input and information
• Establishes and leverages relationships

Technical and Business Expertise

• Is acknowledged as an expert in the organization and acts as an advisor to those within and outside of CMG Training & Development
• Understands the challenges faced by Genentech and creates programs to address the same

Qualifications & Experience:

• Bachelor’s Degree is required; Graduate level or higher degree is preferred
• 6 or more years' experience with 4 or more years' experience in learning technologies, training and development and/or related project management preferably gained within the biotechnology or pharmaceutical industries
• Considerable experience and expertise with web and/or other learning technologies' content management tools
• 2 or more years' experience leading learning technologies' projects, includes development and management from Request for Proposal (RFP) to project completion through ongoing maintenance and development
• Considerable experience with standard project life-cycle management
• Previous field sales, field management or product marketing experience in biotechnology or pharmaceutical industries is a plus