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.
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
- 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
- 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development