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Astellas Pharma Senior Manager of CMC Documentation in Seattle, Washington

Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.

Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.

Universal Cells is announcing an Senior Manager, Analytics opportunity at their facility in Seattle, WA.

Purpose:

The primary purpose of the Senior Manager of Analytics is to manage and coordinate the optimization, qualification, execution, and documentation of analytical methods to enable in-process and characterization testing.

Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.

Essential Job Responsibilities:

  • Leads analytics for in house activities, including management of in-process and characterization testing of gene edited pluripotent stem cells, plasmids, and recombinant Adeno-Associated Virus.
  • Leads and participates in various aspects of the execution of analytical methods, sample transfers, characterization, investigations, assay set-up/running/analysis while collaborating with QA, QC, and Operations teams.
  • Works closely with QA teams to author/review/revise analytical method and sample transfer Standard Operating Procedures (SOPs).
  • Works closely with project managers to coordinate sample transfer, running of assays and results transmittal.
  • Participates in execution of method qualifications and transfers within and outside of Universal Cells.
  • Interacts with contract test laboratories (CTLs) to support sample testing, data analysis and investigations as required.
  • Performs other duties as assigned or special projects as needed

Qualifications:

Required

  • PhD, MS or BS in Molecular Biology, Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent
  • D. with 5+ years laboratory experience; MS with 8+ years or BS with 12+ years
  • Strong organizational, time management, and problem solving skills with attention to detail
  • Ability to work independently and ability to effectively collaborate with other teams
  • Excellent communication and interpersonal skills
  • Experience with analytical method qualification
  • Familiarity with PCR, qPCR assays, and flow cytometry

Preferred

  • Extensive experience with Good Documentation Practices and working within quality system
  • Experience with stem cell biology
  • Experience with gene-editing and cell engineering
  • Experience in the biotech and/or pharmaceutical industry
  • Working knowledge of Southern blotting and Next Generation Sequence analysis

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Research and Development

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