Director - Section Lead, Portfolio, ADQC, US
About The Position
A Section Lead position, a Director-level role, Analytical Development is available within the Analytical Development & Quality Control (ADQC) department for US Biologics in the Pharma Technical Development (PTD) organization. The person will be primarily responsible for providing leadership to a team that supports analytical strategies and deliverables for all biologics pipeline from preclinical to commercial and beyond. This team comprises leaders who drive the overall analytical development, control system strategy, and regulatory filings of multiple projects, molecule analytics leads, and scientists with varying experiences. Key collaborators and interfaces include Quality, Genentech Research, PTD-Europe, Regulatory, other technical development functions, and Technical Development Teams.
Requirements
- PhD in chemistry, biochemistry, biology, or related field with at least 7+ years' experience; or M.S./B.S. with a minimum of 8-12+ years' experience (respectively) in the pharmaceutical/biopharmaceutical industry.
- 5+ years of managerial experience.
- In-depth scientific and technical knowledge and experience in the analytical development of biologics covering a wide array of analytical techniques, CQA knowledge, and comparability strategy
- Demonstrated ability to author, review or approve documents regulatory submissions and support Q&A from health authorities.
- Working knowledge and experience in analytical method development/validation, and cGMP.
- End-to-End CMC and lifecycle understanding
- Demonstrated ability to influence cross-functional at senior level
- Highly motivated and self-driven.
- Good communication skills, organizational skills, detail orientation.
Nice To Haves
- PhD or Master’s degree
- Large team leadership experience in a complex cross-functional environment
- Background and experience in product development and commercialization
Responsibilities
- Lead, coach, mentor and develop a team of about 20 composed of managers, analytical leads, scientists, and associates within the Analytics Development department responsible for biologics analytical development and control strategy for multiple projects from preclinical to commercial, fostering a high-performance environment and people development.
- Provide high-level guidance on analytical strategies for a broad portfolio of molecules (e.g., mAbs, ADCs, bispecifics, bio-conjugates, etc.).
- Ensure all analytical milestones—from candidate selection to BLA—are met across all sub-teams.
- Oversee planning, prioritization, and execution of section deliverables to meet timelines and business needs.
- Manage section capacity, resource allocation, and workload balancing across programs and priorities.
- Drive decisions on control system design and implementation including comparability strategy
- Work closely with the functional leadership team within ADQC to help drive analytical strategies and deliverables, including CQA assessments.
- Support regulatory submissions and Q&As and provides mentorship to authoring
- Represent the company at industry/regulatory forums and external conferences
- Build and maintain collaborations with key partners, e.g., PTD (US & Europe), Research organizations, quality, regulatory, and technical development functions and teams.
- Collaborate on policies & procedures, interact with and influence cross-functional organizations, external partners, and Health Authorities.
Benefits
- Relocation benefits are available for this job posting.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
