What are the responsibilities and job description for the Head of Chemistry, Manufacturing, and Controls (CMC) position at VCLS?
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.
Key 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
Technical Oversight:
- 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
Regulatory Leadership:
- Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation
- Represent CMC in health authority interactions
Vendor Management:
- Manage external partners, including external auditing and consulting partners
- Drive performance and issue resolution
People Leadership:
- Lead and develop a team of 5–10 staff
- Build a high-performing and collaborative culture
Cross-functional Collaboration:
- Partner with Regulatory, non-clinical, clinical, and business development teams to bring phase-appropriate solutions to VCLS clients and build the VCLS business
- 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