Technical Development Senior Principal Scientist, Analytical Development & Quality Control

The Opportunity

A Technical Development Senior Principal Scientist position is available in Genentech's Analytical Development and Quality Control (ADQC) department for US Biologics in the Pharma Technical Development (PTD) organization. The individual will lead a multidisciplinary team of analytical, biological, and quality control scientists in support of the CMC deliverables for protein-based clinical development candidates. Additionally, they will represent Analytical Development and Quality Control on cross-functional project teams, where they will collaborate with leads from other functions on all aspects of CMC project deliverables. Key collaborators and interfaces include Quality, Genentech Research, Regulatory, other technical development functions, and Technical Development Teams.

What You’ll Do

• Lead a team of analytical, biological, and quality control scientists in the development of the strategy and methods required for control system testing and characterization of biological therapeutics

• Support and collaborate with technical development team members on early and/or late stage CMC deliverables.

• Author regulatory submissions and support Health authority information requests

• Strive for molecule CQA understanding  through analytical characterization and collaborations with research,  non-clinical and clinical organization personnel.  

• Build and maintain collaborations with key partners, (e.g.,, Research, quality, regulatory, and other technical development functions and teams)

Who you are

• PhD in chemistry, biochemistry, biology, or related field with at least 8 years' experience; or B.S./M.S. with a minimum of 11 years' experience in the pharmaceutical/biopharmaceutical industry.

• In-depth scientific and technical knowledge and experience in the analytical method development/validation  of biologics covering a wide array of analytical techniques and cGMP

• Demonstrated ability to author, regulatory submissions and support Q&A from health authorities. 

• Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams 

• Strong written and verbal communication skills are required

Preferred:

• PhD or Master’s degree

Relocation funding is available for this role.

The expected salary range for this position based on the primary location of South San Francisco, CA is $143,300 - $266,100. 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.