Head, Analytical Validation

An Analytical Validation Head position is available within the Protein Analytical Chemistry Department, Analytical Development and Quality Control (ADQC, PTDU). The person will be responsible for providing leadership to a team that supports the method validation lifecycle from clinical to commercial including commercial validation.
The responsibilities will include:

• Drive clinical method validation/qualification/transfer strategy and execution with a focus on efficiency while maintaining compliance.
• Lead commercial method validation strategy and execution for clinical and commercial projects.
• Support regulatory submissions, health agency inspections and Q&As.
• Define analytical method system suitability strategies for clinical products and aligning to commercial requirements for IMA enabling validations.
• Develop analytical transfer and training strategies for clinical and commercial stages.
• Lead the implementation of new technologies and methods for clinical and commercial control systems. Act as Genentech/Roche's validation expert for physio-chemistry methods through licensure.
• Attend conferences and track literature to drive and implement industry leading validation strategies.
• Incorporate corporate electronic systems into validation and transfer activities, into electronic systems.
• Represent the company effectively at industry forums, inspections/audits and internal negotiations.
• Build and maintain collaborations with key stakeholders, e.g., PTDU/E, commercial Analytical Sciences, gASAT, IMP Quality, Commercial QC Sites.
• Be a coach and be responsible for people growth and development

Job Requirements

• PhD in chemistry, biochemistry, biology, or related discipline with at least 7 years' experience; or B.S./M.S. with a minimum of 10 years' experience in the pharmaceutical/biopharmaceutical industry. 3+ years of managerial experience.
• In-depth scientific knowledge and experience in the development and validation of analytical methods, covering a wide array of analytical techniques, such as HPLC, UHPLC, CE, Mass Spec, wet-chemistry, etc. Experience with LC/MS-MS is highly desirable.
• The person 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.
• Ability to lead cross-functional Analytical tech transfer team (ATTT), which is responsible for overall planning, coordination, communication of analytical deliverables for a product launch (including method co-validation with the commercial QC sites; method transfer of In-Process, Release and Stability test methods from PTD to commercial QC sites, regulatory filing preparation including authoring pertinent BLA/MAA sections).
• Ability to act as a key player in Roche/Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for OC testing, Extensive in-depth experience with global regulatory filings tor clinical, launch, and commercially approved products across a broad range of products; e.g. therapeutic proteins. recombinant monoclonal antibodies, antibody drug conjugates. Strong experience in the assessment of technical data and scientific information is required.
• Ability to author, review or approve documents (e.g. method validation protocols/ reports, master plan/reports), regulatory submissions and support Q&A from health authorities.
• Working knowledge and experience in analytical method development/validation, and cGMP. Background and experience in product development and commercialization is a plus.
• Highly motivated and self-driven. Good communication skills, organizational skills, detail orientation. Ability to work effectively in a fast paced, multi-disciplinary environment with various projects and timelines.

Please note:

• The expected salary range for this position based on the primary location of South San Francisco, CA is $176,500 to $327,700. Annual Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

• Relocation benefits are available for this job posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.