• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

Position:Safety Scientist

JobPurpose:

The Safety Scientist is responsible for carryingout pharmacovigilance activities on a product or group of products, includingsingle case processing, aggregate reporting, signal detection and evaluation ofPV database. The Safety Scientist supports the Safety Science Leader andis responsible for a particular aspect(s) or segments of the overallprogram. He/She contributes to the benefit risk evaluation and tosafety risk management.

PrimaryResponsibilities and Accountabilities:

Carry out pharmacovigilance and risk managementactivities for specific product or products:

·      Contribute to Pharmacovigilance and RiskManagement planning for designated products by preparation of safetysurveillance strategy and highlighting and tracking potential issues

·      Prepare and review periodic safety reports(PSUR, EU Annual Safety Reports) in accordance with regulatory requirements andPDMS standard operating procedures

·      Coordinate safety activities between PDS andinternal and external partners

Carry out signal detection activities andevaluation:

·      Conduct/support signal detection and evaluationaccording to SOPs and guidelines

·      Carry out medical review of spontaneous casereports and Serious Adverse Event reports from clinical trials, according toSOPs and guidelines

·      Prepare Drug Safety reports, as necessary, forpotential signals

·      Respond to queries relevant to the safety ofRoche products from the affiliates and other internal functions

Contribute drug safety input to activities to defineand implement the Clinical Development strategy for a product or group ofproducts:

·      Provide review of clinical protocols and studyreports to ensure alignment with CDP and safety adequately addressed, andcontributes to the safety section of the Investigators Brochure (IB)

• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

The DMPK group is dedicated to enabling the discovery,development and commercialization of safe and effective medicines by elucidatingthe absorption, distribution, metabolism, excretion and pharmacokineticproperties of small molecule drug candidates. We accomplish this through theapplication of state of the art technologies and sciences of bioanalysis, drugmetabolism, drug transport and pharmacokinetics. The DMPK group works in closepartnership with disciplines such as medicinal chemistry, pharmacology,toxicology, pharmaceutical sciences, clinical pharmacology and regulatory tooptimize leads, select clinical candidates, conduct preclinical developmentstudies, support clinical evaluation and contribute to IND and NDA filings.

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.

Product Manager or Sr. Product Manager - Launch Strategy - Bio-Oncology 

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Each Senior Product Manager has the opportunity to work on molecules at various stages of development.

Key activities for this role include:

• Representation of Managed Care Marketing in product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  Works with cross-functional groups to ensure a seamless and well- integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives. US and Global cross-functional partners include health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Associate Calculations Manager

Associate Calculations Managers support the calculation of complex government pricing calculations to determine government pricing in accordance with strict accuracy targets, timelines, laws, regulations and Government Pricing & Reporting’s (GP) methodology. Associate Calculations Managers also support the peer review process and are responsible for supporting government contracting.

• Acts as a subject matter expert on government contracting, pricing, pricing calculations and reporting
• Participates in the development, education, communication, implementation and ongoing maintenance of Government Calculations Standard Operating Procedures (SOPs), systems, processes, data, reporting templates and the like. Supports development and maintenance of effective GP systems; including suggesting business requirements, potential enhancements and, when applicable, supporting testing processes for new or updated systems
• Creates and implements standard reports
• Supports development and implementation of Government Calculations-specific training; including conducting training for other staff members
• Responsible for ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards  Develops and cultivates professional relationships internally and externally
•  Ensures proactive and regular communication with internal and external partners/stakeholders
• Administers federal government contracting; including IFF, VMI and FSS
• Performs assigned government calculations to ensure timely and accurate completion; including monthly and quarterly AMP, BP, ASP, NFAMP/FCP, PHS and state reporting
• As assigned, supports BP restatement processes
• Validates accuracy of calculations for appropriate government pricing
• Enters relevant data and information into respective departmental/company systems and databases
• Ensures pricing calculations are routed through to appropriate stakeholders and partners for further review, approval and processing  
• Collaborates with Finance and others to reconcile monthly direct sales following prescribed guidelines and timelines; ensuring that any data integrity issues are resolved prior to beginning government pricing calculations
• Prepares and delivers monthly/quarterly data submissions to various internal and external parties, such as government agencies, to meet all compliance and reporting requirements
• Prepares, obtains approval for and ultimately publishes various departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Responds to questions/inquiries regarding assigned government programs and payers
• Reviews the work of less experienced staff members and coaches them on how to administer government contracts, perform and validate government calculations; including explaining SOPs and other requirements
• Supports internal and external audits
• May train and educate others outside of the department in departmental systems, processes, data, reports and the like
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

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...

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in microbiological challenge studies (i.e. disinfectant efficacy testing, antimicrobial effectiveness), sterility testing method and isolator validation, as well as deviation assessment/management.

Main Purpose of the Position:   
• Develop solutions to complex Quality Control testing activities and issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Perform Quality Control testing for product release and stability samples.
• Support quality investigations for testing and test method discrepancies.
• Perform equipment validation for laboratory instruments used in cGMP testing activities.
• Provide input into the generation of stability study protocols.
• Collaborate with departments to ensure product release and stability testing requirements are completed.
• Communicate testing or scheduling issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation and testing activities.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

EXAMPLE DUTIES AND RESPONSIBILITIES:

Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups

Stays abreast of therapeutic area product development and other related business strategies and plans 

Serves as the primary PDR representative on one or more regional projects at any one point in time

Analyzes data, the regulatory environment and business objectives to recommend priorities

Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche

Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development

Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment

Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project

Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management

Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams

Provides internal teams with direction on regulatory authority interactions

Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources

Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made

Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 

Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions ...

Product Manager / Sr. Product Manager – Managed Markets Launch Strategy, Growth Disorders

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch.

PM/SPMs in the Managed Markets Launch Strategy group are generally responsible for multiple molecules at various stages of development. This opening would be primarily focused on leading launch preparations for a compound treating a growth disorder, which could represent a significant advance for patients.

Key activities for this role include:

• Execution of Managed Care Marketing deliverables for product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  Works with cross-functional groups to ensure a seamless and well- integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc.
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives. US and Global cross-functional partners include brand marketing, health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

CORA is part of the broader PDR organization that interprets the needs of worldwide

 health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. CORA Program Directors chair moderate to higher complexity Promotional Review Committees (PRCs), for different products and product development phases, as business needs dictate. CORA Program Directors are responsible for leading and managing the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion for Roche pharmaceutical products and devices. Associate Program Directors are expected to perform their responsibilities with increased independence. 

Intact & Cross-Functional Teams:

• Participates in site, regional and/or global CORA departmental meetings 
• Leads assigned PRCs
• As appropriate, participates as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products. Represents CORA and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution

Commercial Regulatory Affairs:

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and products. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics 
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices 
• Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues.  Communicates significant changes or other relevant matters to internal partners and stakeholders 
• Facilitates the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from health authorities and Roche policies 
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary Roche liaison with relevant personnel in marketing, advertising and communication offices within health authorities 
• Chairs PRC meetings and effectively collaborates with cross-functional internal groups and external advertising agencies 
• Participates in commercial meetings to provide a regulatory perspective on marketing strategies, implementation and promotion objectives 
• Develops and implements effective strategies for health authority marketing, advertising and communications submissions 

Position description and responsibilities:

A position is available in the Protein Analytical Chemistry department for a Scientist with appropriate analytical skills and biopharmaceutical industry experience. The candidate must have strong understanding and hands-on experience in analytical characterization of recombinant therapeutic proteins, development of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, CE and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes for each product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

The Department of Safety Assessment at Genentech providesscientific leadership and plays an active role in the process of drugdevelopment from late-stage discovery through marketed products. We are seeking an Associate Scientist/Scientist in the Department of Safety Assessment to supportdrug discovery and development.   This role will involve working in acollaborative team environment as part of the comprehensive safety assessmentof Genentech therapeutics by providing discovery and investigative toxicologysupport to early stage small molecule research programs.  

Responsibilities

Proactive risk assessment ofpotential toxicity issues related to undesired or exaggerated pharmacology,investigation or characterization of potential toxicity issues to enable smallmolecule lead optimization and candidate nomination.

In this role, the toxicologist willprovide representation to discovery project teams, which will include safetytarget assessments, strategic planning and designing, implementing andsupervising  toxicology studies in support of compound lead optimization(e.g. in vitro toxicity screening, counter-assay development) and mechanisticinvestigations (development of hypothesis-driven research plans, in vitro or invivo model development and qualification, and scientific projectmanagement).  This position will include staff supervision as needed andcontributing to the continued refinement of lead optimization andinvestigational strategies and identification of new technologies.  Thediscovery toxicologist will interact closely with research scientists andSafety Assessment development toxicologists and pathologists to ensure thatdiscovery teams consider all of the appropriate strategic needs for candidateidentification with regard to toxicology issues, thus providing bettercandidate selection and characterization of toxicology issues at the time oftransition to early development.

Description Main Purpose of the Position:

• Direct Quality support staff and operations in accordance with cGMP regulations and Roche standards.
• Provide leadership and guidance to immediate staff hosting inspections or performing Quality Systems functions as assigned.
• Provide the Director, GQIM, with expertise in device and/or combination product inspection issues and risks.

Job Duties/Responsibilities:

• Optimize resources with the PTQS department.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget.
• Monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Roche Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical

Duties/Responsibilities:

• Develop and oversee implementation of the Inspection Risk and Readiness systems to ensure on-going inspection readiness.
• Collaborate with Pharma Technical Operations and Quality areas as needed to identify inspection risks and mitigation plans.
• Serve as a GQIM primary point of contact and liaison for assigned sites
• Manage and oversee the inspection readiness program across sites to ensure proper deployment and reporting of inspection risks
• Lead or support regulatory inspections as appropriate.
• Collaborate with sites to develop and communicate inspection strategy, approach and goals.
• Communicate potential inspection risks and current state of inspection readiness to Senior Management.
• Provide input into the design and presentation of inspection readiness performance metrics
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy.
• Attend and participate in external regulatory and/or compliance organizations, and applicable industry conferences to exchange information regarding current regulatory inspections and to stay current on inspection trends.

Job Duties/Responsibilities:

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

Technical Duties/Responsibilities

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies.