S3

Who we are

At the RocheGroup, about 80,000 people across 150 countries are pushing back the frontiersof healthcare. Working together, we've become one of the world's leadingresearch-focused healthcare groups. A member of the Roche Group, Genentech hasbeen at the forefront of the biotechnology industry for more than 30 years, usinghuman genetic information to develop novel medicines for serious andlife-threatening diseases. The headquarters for Roche pharmaceutical operationsin the United States, Genentech has multiple therapies on the market for cancerand other serious illnesses. Please take this opportunity to learn aboutGenentech, where we believe that our employees are our most important asset andare dedicated to remaining a great place to work.

The Position

The successful candidate will participate in cross-functionalproject teams discovering antibodies with high therapeutic potential to addressmajor unmet medical needs across different therapeutic areas.  This hire will lead a group discoveringantibodies from immunized sources. Research by this group will included enhancing understanding andoptimizing the immune response in immunized mice plus isolation and culturingof antigen-specific B cells.  Thisindividual is expected to collaborate closely with colleagues in other antibodydiscovery groups and other departments.

Act as the main point of contact between Solution Owners, Project Managers and the Operations Support team in the release or implementation of new services, applications or products into production. Ensures smooth transition of new Operational Services and provides implementation support for the Regions

• Ensures tools, processes and procedures are in place to enable the Regions to support new services, applications and products
• Coordinates with the AE&O Support Processes & Continuous Improvement team and the Regional Account Managers on the release and design of new services, applications and products into production 
• Develops methods to track and monitor the Service Health and provide initial reporting
• Acts as the main point of reference and is consulted in Operational AE&O IT projects that impact the tools, processes and technologies used in the Operational Teams in the support of AE&O provided services
• Develops Training material for new Services in collaboration with the solution owner and coordinates the Trainings with the Regional Account Managers
• Assists the Site Implementation Team during the integration of new sites or acquisitions to ensure Processes, Training and Regional/Local Support is in place.   
• Coordinates with the Support Processes & Continuous Improvement Team, the AE&O operational Teams and the Regional Account Managers to ensure tool and Process availability for a upgrade to an existing service, new service release or implementation 
• Ensures and coordinates knowledge base updates with any required information to support a release or implementation
• Ensures Training material availability on new processes and procedures and coordinates Trainings in cooperation with the Regional Account Managers
• Reviews project plans with the Solution Owner or Project Manager for transition planning and provide feedback to ensure a smooth release or implementation.
• Provides reports and monitoring on the impact of releases and implementations on the AE&O operational Teams and the Regional and Local support teams and drives improvements until normal operations are achieved
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• Works with Solution Owners and Project Managers to ensure that requirements of the Operational Teams and the Regional/Local Support teams are represented and understood
• Ensures efficient processes for Operational and Supporting teams and establish an aligned incident escalation chain to reduce escalations. 
• Push automation opportunities for request and change management, reduce escalation of incidents by enforcing Knowledge management usage and validation of KM data.
• Establish early reporting and Service Health metrics with trending information on incidents, requests and changes. 

The ERP Portfolio and Demand Management Coordinator position provides non-technical support primarily to the North American based ERP (Enterprise Resource Planning) team, within the Shared Platforms and Applications area of Pharma Informatics. The global ERP team consists of approximately 180 team members, 50 of which are based in our SSF office. The ERP team mainly supports the business application areas of SAP, Business Warehouse and ARIBA.

This SSF-based position is within the ERP Portfolio and Demand Management team. The ERP Portfolio and Demand Management team is responsible for many important cross-functional topics, such as financial management, demand planning and communication, supporting and advising project managers, process implementation and compliance, audit co-ordination and tracking, metrics and reporting, as well as adhoc management support requests. We support the various managers, project managers and application teams to ensure consistency and efficiency across the ERP Department. 

As part of this small team, you will have a varied and challenging role, working on cross-functional topics while interacting with team members in Basel as well as colleagues other functions (e.g. Finance, Procurement, HR).

You will have the following key responsibilities:

• Support the required financial processes, including the coordination of the budget and monthly outlook events and monitor the budget versus actual spend. Proactively support and advise the SSF based activity owners and project managers on financial topics
• Provide the required financial reports and updates, accurate and timely organizational information and recommendations to ensure the ERP department stays within the given budget
• Support the ERP Team, being the point of contact and advisor for the North American based ERP team with day to day business processes to ensure efficiency and accurate information flow (e.g. purchase order creation and processing, payment of invoices, checking accuracy of accruals, etc.). Advise team members in order to resolve issues in a timely way.
• Manage key relationships and liaise with other departments as required, e.g. Finance, Procurement, HR.
• Support the ERP Team with the needed tools and processes to manage the ERP portfolio of work, which will enable the ERP department to meet the needs of their customers.
• Participate in or lead small projects/initiatives as needed to ensure implementation of common process and tools (e.g. Resource management, Customer satisfaction surveys) and provide ongoing support to the ERP Department
• Assist the Portfolio and Demand Management team establish and report on metrics required by the ERP Solution Owners
• Support and assist with the ongoing improvement of Collaboration tools, such as Touchpoint.

Job Title: Senior Specialist (E4/5)

Job Responsibilities:

·         Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners

·         Manage and monitor milestones and detail timelines for assigned commercial products to ensure the achievement of corporate goals and objectives while providing timely and transparent communication to the PMT subteams and other cross-functional teams.

·         Provide scientific rational for stability study design and propose changes for the Genentech Quality organization

·         Provide scientific and technical leadership in Inspection/ Audit situations, thinking critically and acting creatively while providing information quickly and accurately

·         Author and  provide scientific as well as technical representation of Stability in all stability relevant sections for Submissions, Regulatory Agency responses, APRs and ARs

·         Work closely with other Senior Specialists and senior management to develop strategy for long range operational and resource planning   

·         Serve as a subject matter expert (SME) for stability questions related to assigned commercial products

Associate Group Manager, Government Calculations

The Associate Group Manager, Government Calculations leads and oversees the function and specialist team of calculations managers who process all Government Pricing & Reporting (GP)-related calculations and are accountable for compliance with strict accuracy targets, timelines, laws, regulations, government contracts and GP’s methodology. In addition, the Associate Group Manager is responsible for effective deployment of and improvements to GP Standard Operating Procedures (SOPs), systems, technologies, and data. The Associate Group Manager regularly engages with relevant partners and stakeholders to resolve operational issues. He/she may also lead cross-functional projects from a GP calculations, systems, process or data perspective.

• Acts as the subject matter expert for content and interpretation of various, often complex, government programs, contract strategies, contract issues or terms, e.g. pricing and payment calculations, contract performance, compliance, etc.
• Proactively reviews and assesses existing government programs, contracts, contract administration practices, policies, guidelines, systems, performance tools, etc. versus new, extended or enhanced opportunities. Plays a leadership role in recommending new opportunities; including leading in the development and implementation of such
• In conjunction with Managed Care Contracts Manager, collaborates with the renewal of Federal Supply Schedule Contract
•  Plays a leadership role in GP-wide annual and longer-range strategic and tactical planning
• Leads Government Calculations input into GP annual and longer-range strategic and tactical plans. Includes developing and recommending budget requirements for the work of Government Calculations
• Coordinates with Government Analytics & Compliance on stakeholder meetings and planning initiatives. Provides expert recommendations and perspective to ensure, from the government contracting process and calculations perspectives, effective and efficient policies and contracting strategies
• Develops and cultivates professional relationships internally and externally; including external vendor partners supporting or otherwise involved in work relevant to Government Calculations
• Works with Legal, Government Analytics & Compliance and other groups to evaluate legal and regulatory requirements with government payer pricing and contracting strategies to ensure full and exacting alignment and compliance for Genentech; including all relevant government contracting and calculations processes, monitoring and reporting practices, systems, data and other tools
•  Supports as needed, or otherwise participates in the development of new, enhanced or extended government pricing and contracting strategies
• May present pricing certification decks to senior executives
• Leads development, education, communication, implementation and ongoing maintenance of Government Calculations SOPs, systems, data, reporting templates, and the like. Accountable for development and maintenance of effective GP systems and data
• Plays leadership role in development of performance metrics for monitoring, evaluation and reporting of government payer contracts and programs
• Collaborates with Government Analytics & Compliance to create GP-wide training
• Manages development and implementation of Government Calculations-specific training and ensures team members are provided such training in a timely and thorough manner
•  Leads GP project initiatives specific to GP operations
•  Leads department and team to ensure the highest levels of performance for government contracting processes and price calculations, to include maximum efficiencies and compliance:
•  Manages team to ensure accurate and timely completion of pricing calculations  according to the varying legislation, regulations and terms of contracts for government payers and programs
•  Responsible to ensure ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards and requirements 
•  Reviews and approves pricing calculations from team members. Ensures pricing calculations are provided to other Government Pricing & Reporting partners to ensure timely and accurate processing
•  Regularly monitors compliance to internal and external policies
•  Manages any issue resolution 
•  Responds to questions from team members and other partners/stakeholders regarding complex issues that may require interpretation
•  Ensures team prepares and delivers routine and ad hoc reporting, as per departmental guidelines, standardized work practices, or otherwise as needed
• Self and team participate in internal and external auditing; including...

The Scientist will be a member of the Protein Analytical Chemistry Validation Department (PAC-V). PAC-V is one of the seven departments that comprise Analytical Development and Quality Control  (ADQC) organization within Process Research and Development.

PAC-V  is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system. PAC-V is responsible for both the development and execution of the strategies. The candidate will provide practical guidance and expertise to ensure the appropriate and timely progression of acceptable validation activities across the Protein Analytical Chemistry Department.

The candidate must have in depth scientific knowledge and hands-on experience in the development, robustness testing, and validation of analytical methods, covering a wide array of analytical techniques such as HPLC, CE, MS, and wet-chemistry. He or she will be involved to ensure the proper and timely execution of all aspects of the life cycle clinical analytical methods across Genentech's clinical product portfolio and testing sites (including CMOs and partners).

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for QC testing. The candidate is also expected to represent PAC-V in cross functional teams. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.

The Senior Scientist, in vivo pharmacology, will lead a translational research group focused on immune-mediated oncology therapeutics. The successful candidate will work closely with other disciplines within Genentech to drive research stage programs into early clinical development, providing scientific and strategic leadership, and technical management. The individual must be motivated to work in a scientifically rigorous, fast-paced environment to achieve key results that drive program decision-making. The ideal candidate will have an in-depth understanding of immunology, cancer biology and animal models with a strong publication record.

Summary of Key Responsibilities:

• Lead translational research group primarily supporting tumor immunotherapy programs.
• Develop experimental strategies to define/validate the mechanism of action and mechanism of resistance of immune-mediated anti-tumor therapeutics.
• Provide in vivo pharmacology expertise to project teams during the discovery and development phases of biologics and small molecule drug discovery programs.
• Define PK/PD/efficacy relationships in collaboration with colleagues within DMPK and research oncology.
• Develop innovative preclinical animal models that enable interrogation of mechanisms of action, diagnostic hypotheses, and mechanisms of resistance.
• Direct management of up to 5 research associates, in vivo and in vitro. Develop and assess goals of direct reports.
• Responsible for authoring documents to support regulatory filings and patent applications.

Job Description:

A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of high throughput experiments and lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.

This is a term position for approximately 9 months

Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations.  Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site.  Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing.  This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.  

Job Responsibilities

Essential

Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
Generate, review, approve and maintain Qualification Project Plans and Summary Reports and other validation lifecycle documents for automated systems.
Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs) for automated systems.
Manage protocol execution, perform data review and manage deviation resolution.
Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
Strong understanding of commercial production environment and requirements.
Evaluate and audit the current validated status of automated systems.  Make suggestions for improvements as well as ensure system is operating in compliance and validated state.
Present validation packages for automated systems as required for audits and/or regulatory inspections.
Perform role of subject matter expert and assess change control and discrepancy events for automation systems.
Review automation validation lifecycle documents for compliance with CFRs, corporate requirements, and site procedures.
Lead group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

Product Manager / Senior Product Manager 

 
Managed Care Marketing (MCM) supports Genentech’s business by designing managed care marketing strategies, plans and programs for Genentech’s pipeline and in-line portfolio that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices).

For pipeline products, MCM supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Senior Product Managers are generally responsible for multiple molecules at various stages of development.

For in-line products, Senior Product Managers act as a primary liaison to managed care account managers (for payer and channel customers) and field reimbursement managers (FRM) (for practices) and may have matrix responsibilities to represent MCM for one or more products or franchises.
 
Product Manager / Senior Product Manager responsibilities may include:

Overall

• Creates and delivers managed care marketing strategies and programs; manages relevant agencies and budgets
• Works with US and/or Global cross-functional groups to ensure a seamless and well-integrated messages and overall positioning across multiple marketing platforms
• Aligns therapeutic area and managed care marketing strategies and tactics with pricing, reimbursement, contracting, distribution and other relevant functions
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year brand strategies and tactical plans
• Educates internal partners and stakeholders on the US managed care landscape and its implications to current and future managed care marketing strategies, plans and objectives
• Continuously refines knowledge of internal and external business drivers of the managed care landscape and their implications for Genentech
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall results
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

For pipeline molecules

• Leads managed care strategic planning to contribute to Phase III drug development investment decisions, trial design, and overall value proposition
• Builds, implements and manages the managed care marketing plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (as relevant)

For in-line products

• Acts as a key liaison to managed care customer-facing teams and to relevant brand teams
• Works with various MCCO account management teams to effectively and efficiently apply branded and non-branded promotional resources or other relevant resources to accounts, as appropriate 
• Provides strategic consultation to account management-led account planning
• Reviews and assesses cross-functional business strategies, plans and tactics; recommends managed care marketing strategies, plans and activities that support optimal positioning and reimbursement of and access to Genentech medicines
• Creates and manages 3-year and 1-year managed care marketing strategies, plans, and tactics for specific managed care segments
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives.

Position Summary:

The Commercial Control System Lifecycle Management function of MMTech at Genentech has an open position for a QC Scientist/Senior QC Scientist to support lifecycle management of commercial biologics control systems.  This position is part of a function responsible for developing and implementing strategies to systematically evaluate and update control systems for the Genentech/Roche product portfolio.   

MMTech is part of the Genentech/Roche commercial quality organization and is responsible for method validation, control systems and specifications, reference standards, assay transfers, and providing scientific/technical support for the global QC Network across the commercial biotechnology product portfolio.

Job Description:

The individual will support the development, implementation, and maintenance of strategies to systematically assess and update commercial product control systems.  He/she will manage product, process, and external knowledge to ensure that control systems reflect current product and process understanding, analytical technologies, and Health Authority expectations.  The individual will be responsible for contributing to reports that document information supporting control system assessments and revisions.

As part of the control system evaluation and revision, this individual will:

• Oversee comprehensive control system assessments based on: identification of critical quality attributes, method and process capabilities, current industry practices, and contemporary Health Authority expectations
• Lead cross functional technical teams that perform detailed physicochemical characterization, method development/validation, and sample testing so that control system revisions are effectively managed and aligned with present-day requirements
• Provide scientific input and technical oversight to support control system changes
• Partner with subject matter experts to identify and complete key activities required for control system updates
• Collect and analyze results from product release and stability testing for use in evaluating and updating specification acceptance criteria
• Provide technical review and approval of analytical control system cGMP documents
• Support and coordinate quality assurance activities/reviews in Quality systems (e.g. Change Control, Discrepancy Management, etc.) to ensure compliance to procedures, current GMPs, and regulatory requirements
• Support regulatory submissions and inspections through authorship of relevant CMC sections, written responses to agency requests, and direct interactions with Health Authorities

Applicants should be comfortable working both independently and collaboratively as part of a team. The position offers opportunities for professional and scientific growth in a dynamic work environment.

E2/E3 position depending on experience of candidate.

Perform microbiological testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.  Review data and assess against established acceptance criteria.  Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.  Participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.  Support nonroutine microbiological projects and studies.  Prepare and maintain standards, controls and stock cultures per established protocols.  Support the maintenance and compliance of operational areas.  Assure strict adherence to cGMPs throughout operation.  Ensure training qualifications are up to date.  Identify and support resolution of technical problems.  Actively participate in group projects and process improvements.  Perform routine maintenance duties to ensure inspection ready state.  Draft protocols and reports under supervision.  Work with internal and external groups to develop methods for clinical products for in process and final products testing.

Responsibilities: This position is for a Validation Engineer I/Manufacturing Technical Specialist I - Validation reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise.

·         Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies

·         Lead product complaint investigations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 

·         Ensure appropriate application & integration of cGMPs in the product complaints management system.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines and manage competing priorities/

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Develop, train, and mentor personnel and internal customers on relevant business processes.

·         Collaborate and author department policies and procedures.

·         Make decisions that impact the goals and objectives of the department.

·         Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes.

·         Review and approve product complaint investigation reports and supporting documentation. 

·         Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.

·         Educate departments on the best practices for conducting investigations and root cause analysis.

·         Lead project teams to resolve deficiencies identified through the root cause analysis process.

·         Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

·         Present product complaint records and/or reports during periodic audits and regulatory inspections.

·         Perform any other tasks as requested by Management to support Quality oversight activities

This is a 2 year TERM position:

The primary responsibility of this position will be to report to the
operations Sr. Manager in charge of a global group that executes
testing (cell based and PCR based platforms) for adventitious agents,
i.e., virus, mycoplasma in CHO-derived products following established
procedures and in compliance with cGMP’s.  The position will require
work in the laboratory executing the test methods for both routine lot
release and validation of the methods on a product specific bases.
The analyst in this position will be expected to execute other QC
laboratory related activities with other team members like sampling
handling, equipment maintenance and review of QC batch test records
and certificates of analysis.  The position will also be expected to
author study reports and draft protocols for approval on validation
and/or investigational studies, review and/or author discrepancy
protocols and assessments.  Opportunities for participation as a
trainer on various topics related the detection methods utilized in
the lab, regulations that govern the use of those methods and topics
about Quality and compliance will also be available.

The Genentech Research and Early Development (gRED) Clinical Trial Manager (CTM) provides support and/or leadership to one or more global Study Teams within an early development program(s). The CTM is accountable for activities ensuring high quality deliverables are within budget and timelines.  

Primary Accountabilities and Responsibilities:

• Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL

• Responsible for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget

• Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor

• Provide input to the study budget and is responsible for managing assigned vendor budget(s)

• Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management)

• Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate

• Partner with CPL to develop and/or present at project teams and management review bodies

• Conduct protocol and site feasibility assessments

• Provide support, mentoring, and study-specific training to Clinical Operations staff

• Network and share best practices with colleagues to ensure optimal efficiency and consistency in Clinical Operations

• Participate in initiatives and/or activities as assigned

Responsibilities and Accountabilities When Leading a Study:

Depending on skill level and study design, CTM may lead Study Team, including obtaining agreement on project timelines, study objectives and goals.

• Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines

• Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets

• Provide input to the program budget and is accountable for managing overall study budget

• Delegate and oversee study activities assigned to Clinical Operations Study Team as applicable

• Provide drug supply assumptions to clinical planning team

These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.