Head of Chemistry, Manufacturing, and Controls (CMC)

VCLS • Boston, MA

3d

About The Position

We are seeking an experienced and strategic Head of Chemistry, Manufacturing, and Controls (CMC) to lead the development and execution of global CMC strategy across a diverse therapeutic portfolio. This individual will provide technical and organizational leadership for biologics, combination products, oligonucleotides, and cell and gene therapy programs, spanning early development through late-stage development and commercialization readiness. The successful candidate will combine deep drug development expertise, strong cross-functional leadership, and proven experience building, managing, and developing teams. Consulting experience is a plus.

Requirements

• Degree in a relevant scientific discipline
• Significant industry experience in CMC and drug development
• Expertise across biologics, oligonucleotides, combination products, and cell & gene therapies
• Experience managing mid to large teams
• Strong regulatory submission experience (US and/or UK/EU)
• Knowledge of GMP and global regulatory requirements
• Experience with CDMOs

Nice To Haves

• Consulting experience is a plus.

Responsibilities

• Define and lead phase-appropriate global CMC strategies across modalities for a diverse range of global clients
• Provide thought leadership to raise the VCLS profile, including speaking at conferences, presenting webinars, and meeting VCLS clients
• Enable our clients’ development of biologics, oligonucleotides, combination products, and cell & gene therapies
• Guide scalable manufacturing and analytical strategies
• Write and review technical documentation, and provide input and support for CMC team members
• Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation
• Represent CMC in health authority interactions
• Manage external partners, including external auditing and consulting partners
• Drive performance and issue resolution
• Lead and develop a team of 5–10 staff
• Build a high-performing and collaborative culture
• Partner with Regulatory, non-clinical, clinical, and business development teams to bring phase-appropriate solutions to VCLS clients and build the VCLS business

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed