Role OverviewA key member of the leadership team, the Senior Vice President, Chemistry, Manufacturing and Controls (SVP, CMC) will oversee the company's entire out-sourced manufacturing effort, providing vision, leadership, strategy, and management skills to expand manufacturing from preclinical to commercial stages. The SVP, CMC will have oversight over global pharmaceutical manufacturing, fill/finish, packaging, supply chain, logistics, and quality control.
What You Will Do
The SVP, CMC will lead assessments and analyses, provide technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions. They will also lead the development and implementation of integrated CMC regulatory strategies for First Tracks Bio's pipeline projects.
Why It Might Be a Fit
The ideal candidate will be a seasoned pharma/biotech executive with an outstanding record of accomplishment in R&D manufacturing of biologics, quality, supply chain management, and logistics. They will have experience in the global submission and maintenance of CMC sections of regulatory (BLA) filings and have previously worked on biologics CMC development programs that have been filed and approved for registration with the FDA and other global regulatory bodies.
Requirements
- B.S is required, PhD preferred
- Minimum of fifteen years' experience in a senior management level role in CMC
- Strong record of accomplishments and successful leadership experience in biologics drug development and commercial drug product manufacturing
- Proven track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies
Benefits
- Reliable preclinical, clinical, and future supply of safe, high-quality drug products
- Opportunity to serve as a driving force in building and expanding First Tracks Bio's pharmaceutical development and manufacturing organizations
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