Director, Analytical Development - BioPhase Solutions
16000 Temple Ave
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BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Director, Analytical Development to work for a leading Greater Los Angeles areabiopharmaceutical company. Responsibilities:
Lead Product and Vector Characterization and Analytical activities in support of engineered T cell products, including oversight of cross-functional teams
Design, develop, execute and document analytical methods to study and characterize processes for production of T cell therapies
Lead analytical laboratory staff in the selection, design and implementation of novel analytical methods, including FACS
Ensure standard operating procedures, analytical test methods, analytical sampling plans and batch records meet the highest industry standard
Review and approve technical documents
Work with a cross-functional development team to advance T cell therapy programs
Introduce analytical methods for cell therapy products including process improvements and efficiencies
Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
Ensure a collaborative work environment with key client groups in Research, Quality and Manufacturing
Ph.D. inlife sciences
Previous experience with cell therapy products is a plus
Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, analytical method development, technology transfer, methodqualification/validationand process development