Technical Development Principal Scientist

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

We are seeking a motivated and experienced Technical Development Principal Scientist to join the Protein Analytical Chemistry Department at Genentech. The successful candidate will work in a highly collaborative team environment to lead and deliver analytical method development, product variant characterization, and control strategies for late stage (phase III to commercial) protein therapeutic development. Additionally, the successful candidate will serve as an analytical representative on cross-functional project teams collaborating with colleagues in Cell Culture, Purification, Pharm Development, Quality and Regulatory groups.

What You'll Do

• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods to support protein characterization, process development, comparability assessment, method qualification/validation, and other late stage analytical activities.

• Perform physicochemical characterization of protein therapeutics (such as antibody drugs and new protein drug modalities) to determine critical quality attributes.

• Provide technical support of analytical method qualification, validation, and transfer activities.

• Author and review technical development documents and relevant sections of health authority filings.

• Define and perform comparability assessment to support late stage clinical development and commercial launch programs.

• Assist in defining and executing phase appropriate analytical control strategy to enable CMC development timelines.

• Hands-on, technical execution in the laboratory while providing mentorship to junior colleagues.

• Ensure timely analytical support for bioprocess/formulation development and process validation activities.

• Maintain timely and accurate lab records consistent with good documentation practices.

• Serve as a team representative and provide analytical knowledge and expertise to cross-functional teams.

Who You Are

• Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline plus a minimum of 3+ years analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 8+ years of experience.

• Demonstrated track record of successful analytical method development and product characterization for late stage protein therapeutic development.

• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization methods (e.g. HPLC-based methods, capillary electrophoresis, LC/MS peptide mapping, etc.).

• Prior experience with Phase III IND and BLA authoring considered a plus.

• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams.

• Excellent critical thinking, scientific problem-solving, and organizational skills.

• Excellent oral and written communication skills.

• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.

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 $120,800 - $224,300. 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.