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
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
