What are the responsibilities and job description for the Head of Manufacturing position at TSP, a Syneos Health company?
Description
About the Role
Late clinical‑stage rare disease company is preparing for NDA submission and commercial readiness and seeking a Head of Manufacturing to lead all aspects of CMC, scale‑up, tech transfer, and commercial supply strategy.
This is a hands‑on leadership role ideal for someone who thrives in small, fast‑moving biopharma environments and has deep experience with solid oral or topical drug products.
Key Responsibilities
Manufacturing & Scale‑Up
Must‑Have
About the Role
Late clinical‑stage rare disease company is preparing for NDA submission and commercial readiness and seeking a Head of Manufacturing to lead all aspects of CMC, scale‑up, tech transfer, and commercial supply strategy.
This is a hands‑on leadership role ideal for someone who thrives in small, fast‑moving biopharma environments and has deep experience with solid oral or topical drug products.
Key Responsibilities
Manufacturing & Scale‑Up
- Lead scale‑up of from clinical to commercial scale via CDMO partnerships.
- Ensure robust process validation and commercial readiness.
- Lead tech transfer to external manufacturing partners.
- Establish and manage CDMO relationships, including quality agreements, timelines, and performance metrics.
- Troubleshoot manufacturing issues and drive continuous improvement.
- Prepare and review regulatory documentation, including process descriptions, control strategies, and validation packages.
- Serve as the primary technical representative in FDA interactions related to manufacturing.
- Ensure GMP compliance across all manufacturing activities.
- Partner with Head of Quality to establish specifications, release criteria, and stability programs.
- Support audits and inspections.
Must‑Have
- 10 years in branded/specialty pharmaceutical manufacturing in a GMP environment with significant experience in solid, semi‑solid, or topical products.
- Demonstrated success scaling products from clinical to commercial manufacturing,
- Strong CMC experience with at least one NDA or BLA submission.
- Hands‑on experience with CDMO oversight and tech transfer.
- Deep understanding of GMP, process validation, and quality systems.
- Experience in rare‑disease drug development or small‑batch commercial supply.
- Experience with accelerated approval or priority review pathways.
- Prior leadership in a small or emerging biotech or pharmaceutical company.