In Pharma Technical Development (PTD), we actively collaborate and develop creative technical solutions to efficiently transform scientific ideas into products. Our mission is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication and mutual respect, and contributes every single day, continuously improving what it does.
Global Analytical Development and Quality Control (ADQC) organization is a leader in developing, validating, and executing physico-chemical, immunochemical, and biological methods for our biologics pipeline. This function provides integrated analytical control strategies and systems that enable CMC development of biologic therapeutics, process development, product characterization, and drug delivery for biologic products from research (molecular assessment) through post product launch.
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)
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 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 $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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Top Skills
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.
.png)
