Head of Chemistry, Manufacturing, and Controls (CMC)
New
V
VCLSBiotechnology, Pharmaceuticals
Boston, Massachusetts, United States. San Francisco, California, United StatesFull-TimeSenior
Salary not disclosed
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Job Details
Requirements
- Degree in a relevant scientific discipline.
- Significant industry experience in CMC and drug development.
- Deep expertise across biologics, oligonucleotides, combination products, and cell & gene therapies.
- Experience managing mid to large teams.
- Proven experience building and developing high-performing teams.
- Strong regulatory submission experience in the US and/or UK/EU.
- Knowledge of GMP and global regulatory requirements.
- Experience working with CDMOs.
- Consulting experience is a plus.
Responsibilities
- Define and lead phase-appropriate global CMC strategies across diverse therapeutic modalities.
- Oversee the preparation and submission of CMC documentation for IND, CTA, BLA, NDA, MAA, and IMPD filings.
- Represent the CMC function during health authority interactions.
- Provide technical guidance on scalable manufacturing and analytical strategies.
- Manage and resolve issues with external partners and CDMOs.
- Lead, develop, and mentor a team of 5–10 staff members.
- Collaborate cross-functionally with regulatory, non-clinical, clinical, and business development teams.
- Provide thought leadership for the company by speaking at conferences and presenting webinars.
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