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Senior Technical Manager - Analytical Development

Genentech · South San Francisco · On-site

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About Genentech

Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.

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. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • 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
  • Excellent interpersonal, verbal, and written communication skills including experience authoring CMC regulatory documents
  • Proven hands-on expertise with multicolor flow cytometry, cell-based assays, or complementary platforms (e.g., qPCR, ddPCR, ELISA, NGS)
More about this role

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!

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.

The successful candidate will be responsible for establishing analytical methods and implementing best practices in support of cell therapy process and product development including the development and implementation of best-in-class analytical testing strategies to control and characterize products. Operating in a cross-functional and dynamic environment, the individual will partner with Process Development, Quality Control, Manufacturing Sciences and Technology, Product Development, Regulatory Affairs, and Manufacturing teams.

The ideal candidates should have experience managing daily operations of a team and implementing analytical testing methods that are compliant with regulatory requirements. This role leads...

Read the full posting on Genentech's site ↗

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