About the Position:

Our client, a leading company in the pharmaceutical and biotech industry, is seeking a Senior Manager of Manufacturing Sciences and Technology (MSAT) to lead a multi-functional team in support of innovative cell/gene modified autologous and allogeneic cell therapy manufacturing processes. The successful candidate will have extensive experience with cell/gene therapy processes, deep expertise in the underlying science and technology, and a thorough understanding of CMC requirements for IND/NDA filings. This position offers the opportunity to grow within an innovative organization and contribute to the development of cutting-edge cell therapy products.

Qualifications:

• Ph.D. in a scientific or bioengineering discipline with 6-8 years of experience, or M.S. with 8-10 years of experience in MSAT or manufacturing of cell and gene therapies, vaccines, or biologics
• At least 5 years of experience managing a technically sound, scientific multi-functional team
• Minimum of 5 years of experience in FDA-regulated industry with experience in evaluating process materials and components in the cell therapy biotechnology industry
• Direct experience with cell and gene therapy process execution, IND filing, and supporting clinical products is required
• Fully competent and experienced working with cGMP Quality systems and demonstrated capabilities of conducting manufacturing deviation investigations, determining root cause using RCA tools and techniques

Requirements:

• Extensive knowledge of GMP requirements for cell therapy processes
• Experience in cell processing
• Experience in new equipment evaluation and optimization of processes
• Experience with documentation (e.g. creating SOPs, Batch records, using electronic lab notebooks)
• Experience with Tech transfer
• Experience with change controls and CAPAs
• Collaboration with other departments such as QA, Analytics, QC, and manufacturing

Benefits:

• Base Salary: USD $150,000 to $165,000
• Full-time position
• Location: Arcadia, California, United States
• Office space available at location listed
• 100% onsite

QHvuGyP9cT