Technical Development Senior Principal Scientist, Analytical Development & Quality Control

Posted 17 Days Ago
Be an Early Applicant
South San Francisco, CA
143K-266K Annually
Senior level
Healthtech • Biotech
The Role
Lead a team of scientists in analytical method development for biologics, collaborate on CMC deliverables, and manage regulatory submissions.
Summary Generated by Built In

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.

Top Skills

Analytical Method Development
Cgmp
Validation
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The Company
HQ: South San Francisco, CA
20,069 Employees
On-site Workplace
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

Making a difference in the lives of millions starts when you make a change in yours.

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