Chapter Lead, Senior Director, Analytical Development and Quality Control

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech, a member of the Roche Group.

The Opportunity

A Chapter Lead position, a Senior Director-level role, 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 to provide 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. Key collaborators and interfaces include Quality, Genentech Research, PTD-Europe, Regulatory, other technical development functions, and Technical Development Teams.

The responsibilities will include: 

• Lead and mentor a team of 8-10 leaders, wherein, each leader is further responsible for biologics analytical development and control strategy for multiple projects from preclinical to commercial 

• 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.

• Foster people development and growth through coaching and mentoring

Who you are

• PhD in chemistry, biochemistry, biology, or related field with at least 12 years' experience; or B.S./M.S. with a minimum of 15 years' experience 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

• 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.

• 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. 

Preferred:

• PhD or Master’s degree 

• Large team leadership experience in a complex cross-functional environment

• Background and experience in product development and commercialization

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $202,100 to $375,300.  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.

Benefits

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.