Director/Snr Director CMC & External Manufacturing
Salary undisclosed
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Director/Snr Director CMC & External Manufacturing
I am currently partnered with for an exciting and well funded biopharmaceutical company. They have a diverse pipeline of small and large molecules, with this role primarily focused on leading their Phase 2/3 small molecule program, while also contributing to early-phase projects.
Reporting to the VP of Manufacturing, this role oversees CDMO programs, particularly on the API manufacturing and supply cahin side.
Responsibilities
- Develop and implement a comprehensive manufacturing strategy for a diverse pipeline, including both small and large molecules in late-stage development (Phase 2/3).
- Oversee all aspects of process development and manufacturing, from early-stage clinical development through to commercialization.
- Identify, evaluate, and manage external Contract Development & Manufacturing Organizations (CDMOs) to optimize processes, ensure cGMP production of critical materials, and support clinical and commercial supply in accordance with global regulatory standards (cGMP, ICH, FDA).
- Proactively assess technical challenges and risks, collaborating with internal teams to develop strategic mitigation plans.
- Lead and mentor a team of scientists and engineers to drive operational excellence.
- Guide the development and validation of analytical methodologies to support process optimization and characterization.
- Shape regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) to ensure a streamlined and phase-appropriate approach to process development.
- Act as a technical subject matter expert in discussions with regulatory agencies, providing insight into precursor and API development.
Qualifications
- Advanced degree in relevant field with 8+ years experience in Manufacutring/CMC/API Manufacturing
- Hands-on experience in cGMP manufacturing of small molecules or peptides is required; familiarity with biologics is a strong plus.
- Proven ability to manage global CDMOs for the production of cGMP materials, ensuring compliance and efficiency under tight timelines.
- Experience in API manufacturing required.
- Strong leadership and communication skills, with the ability to collaborate cross-functionally and influence strategic decisions in a high-growth environment.
- Experience in regulatory submissions and interactions, with a solid understanding of CMC requirements for late-stage clinical programs.
- Highly organized, self-motivated, and adaptable to a fast-paced startup or biotech setting.
Director/Snr Director CMC & External Manufacturing
I am currently partnered with for an exciting and well funded biopharmaceutical company. They have a diverse pipeline of small and large molecules, with this role primarily focused on leading their Phase 2/3 small molecule program, while also contributing to early-phase projects.
Reporting to the VP of Manufacturing, this role oversees CDMO programs, particularly on the API manufacturing and supply cahin side.
Responsibilities
- Develop and implement a comprehensive manufacturing strategy for a diverse pipeline, including both small and large molecules in late-stage development (Phase 2/3).
- Oversee all aspects of process development and manufacturing, from early-stage clinical development through to commercialization.
- Identify, evaluate, and manage external Contract Development & Manufacturing Organizations (CDMOs) to optimize processes, ensure cGMP production of critical materials, and support clinical and commercial supply in accordance with global regulatory standards (cGMP, ICH, FDA).
- Proactively assess technical challenges and risks, collaborating with internal teams to develop strategic mitigation plans.
- Lead and mentor a team of scientists and engineers to drive operational excellence.
- Guide the development and validation of analytical methodologies to support process optimization and characterization.
- Shape regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) to ensure a streamlined and phase-appropriate approach to process development.
- Act as a technical subject matter expert in discussions with regulatory agencies, providing insight into precursor and API development.
Qualifications
- Advanced degree in relevant field with 8+ years experience in Manufacutring/CMC/API Manufacturing
- Hands-on experience in cGMP manufacturing of small molecules or peptides is required; familiarity with biologics is a strong plus.
- Proven ability to manage global CDMOs for the production of cGMP materials, ensuring compliance and efficiency under tight timelines.
- Experience in API manufacturing required.
- Strong leadership and communication skills, with the ability to collaborate cross-functionally and influence strategic decisions in a high-growth environment.
- Experience in regulatory submissions and interactions, with a solid understanding of CMC requirements for late-stage clinical programs.
- Highly organized, self-motivated, and adaptable to a fast-paced startup or biotech setting.