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  3. Head of Chemistry, Manufacturing, and Controls (CMC)

Head of Chemistry, Manufacturing, and Controls (CMC)

VCLS
Posted 3 months ago, valid for 8 days
Location

San Francisco, CA 94102, US

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • We are looking for a Head of Chemistry, Manufacturing, and Controls (CMC) with significant industry experience in drug development and a strong background in biologics, oligonucleotides, combination products, and cell & gene therapies.
  • The role requires a minimum of 10 years of relevant experience, including leadership in CMC strategy and team management, with a focus on building a collaborative culture.
  • Key responsibilities include defining global CMC strategies, overseeing regulatory documentation, and managing external partners to ensure project success.
  • The candidate will also provide thought leadership and represent the CMC function in health authority interactions while leading a team of 5-10 staff.
  • Salary for this position is competitive and commensurate with experience, reflecting the strategic importance of the role.

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 



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