Senior Manager of Contract Manufacturing

About the Position: This position is responsible for leading the oversight of Obsidian's network of contract development and manufacturing organizations (CDMOs) inclusive of cell therapy drug substance / drug product and viral vector drug substance production for both clinical phase and commercial phase products.

The ideal candidate will have a strong background in cGMP operations, with experience in cell and gene therapy. They should possess excellent analytical and strategic problem-solving skills, with the ability to drive timely and fact-based decision making in complex scenarios.

Your Key Responsibilities:

• Define and lead overall governance system for CDMOs from strategic to daily management oversight ensuring processes and practices are compliant with global current good manufacturing practices.
• Partner with technical teams and program management to facilitate technical transfer of processes to new CDMOs including development and revision of batch records and procedures, management of change controls, and establishing comprehensive process and equipment training programs.
• Review and/or author technical and project protocols and plans and reports in support of technical studies, stage gate reviews, and global regulatory filings.
• Acting as virtual Plant Manager and value stream team leader, partner with MS&T, QC/QA, and Supply Chain to oversee external production of clinical and commercial cell therapy products and ensure timely disposition of product.
• Develop and build a high-performing manufacturing team to execute department responsibilities and achieve corporate and department objectives.