Senior Director/Executive Director CMC
AL Solutions
Boston, massachusetts
- Build and lead CMC teams dedicated to the development and optimization of protein biologics processes.
- Utilize your CMC expertise to steer the nomination of Development Candidates.
- Select and collaborate with CDMOs; craft contracts in partnership with Executive Leadership and Finance.
- Oversee the transfer and management of manufacturing processes with CDMOs, ranging from candidate nomination to process and analytical development, and advancing to early phase clinical manufacturing.
- Facilitate the transfer and support of analytical methods at external CROs/CDMOs.
- Direct analytical and stability programs at CROs to ensure the highest quality.
- Prepare and review technical documents and reports essential for regulatory submissions.
- Define and manage objectives, operating plans, production milestones, and overall goals for CDMO/CRO contracts.
- Spot opportunities to expedite manufacturing processes to ensure...