Genentech
Senior Technical Manager - Analytical Development
South San Francisco, USA · Senior
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About the role
- We are seeking a highly-motivated individual with a breadth of analytical development expertise to provide scientific and technical leadership to the flow cytometry analytical development team.
Responsibilities
- Lead and execute studies for the selection and development of robust, state-of-the art multicolor flow cytometry methods and cell-based assays to monitor final product quality attributes and process performance.
- Manage method and analytical technology transfer to the GMP QC team and external partners
- Enable a collaborative work environment with key groups to support analytical method development as well as the characterization of cell therapy products
- Provide training, mentorship, and support to other teams developing flow cytometry methods, as a technical expert
- Maintain knowledge of industry trends and critically evaluate analytical technology platforms, single cell analysis technologies and scientific literature in order to contribute maximally to cell therapy analytical development efforts.
- Draft technical reports, standard operating procedures, and test protocols in support of analytical development.
- Excellent interpersonal, verbal, and written communication skills including experience authoring CMC regulatory documents
Requirements
- Ph.D. in Biological Sciences or other related field with 3+ years of relevant experience in the biotech and/or pharmaceutical industry preferably in cell therapy.
- MS/BS considered with 9+ years of relevant experience.
- Proven supervision and mentoring of analytical development teams, preferably for cell therapy products
- Strong background applying QbD principles along with practical knowledge of relevant cGMPs, ICH, and FDA regulatory framework expectations.
- Proficiency in relevant statistical methods including application of design of experiment (DOE) for development and lifecycle management of analytical methods
- Proven hands-on expertise with multicolor flow cytometry, cell-based assays, or complementary platforms (e.g., qPCR, ddPCR, ELISA, NGS)
Nice to have
- Expertise in stem cell biology, immunology and/or cancer biology is strongly preferred
Compensation
- The expected salary range for this position based on the primary location of South San Francisco, CA is $146,500 - $272,100.
Company info
- The Opportunity We are seeking a highly-motivated individual with a breadth of analytical development expertise to provide scientific and technical leadership to the flow cytometry analytical development team.
Equal opportunity
- equal opportunity employer.
- If you have a disability and need an accommodation in relation to the online
This listing is sourced directly from Genentech's careers page and normalized into a canonical job model.