Senior Principal Research Scientist and Analytical Development Leader

6 days ago


San Francisco, California, United States Genentech Full time

About the Role
The Genentech team is seeking a highly skilled Senior Principal Scientist to join the Analytical Development department in South San Francisco. As a key member of the Pharma Technical Cell & Gene Therapy (PTC) organization, you will be responsible for developing cell-based potency and characterization assays to drive process/product understanding through molecular and cellular approaches.

Key Responsibilities
You will lead analytical method development and optimization for regenerative medicine cell therapy programs in ophthalmology. This includes establishing specifications of drug product, cell banks, and in-process controls based on historical datasets and analytical method performance. You will also contribute to authoring and reviewing CMC sections in regulatory filings and spearhead analytical testing to enable process understanding, support pharmaceutical development studies, and comparability exercises.

Requirements
To succeed in this role, you should have a Ph.D. with 6+ years of relevant analytical development experience, particularly focused on cell and gene therapies. You should possess a working knowledge of control strategy development, including Critical Quality Attribute identification, and a fundamental understanding of ICH, FDA, and USP guidelines for analytical development and CGT products.

What We Offer
This is an excellent opportunity to make a significant impact at Genentech as we strive to be an industry leader in cell therapy development. The expected salary range for this position is $143,500 - $253,900 per year, depending on qualifications and experience. Relocation funding is available for this role. Additionally, you will receive benefits such as health insurance, retirement plans, and paid time off. At Genentech, we are committed to diversity, equity, and inclusion and prohibit unlawful discrimination based on various protected characteristics.



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