# Head of Chemistry, Manufacturing, and Controls (CMC)

> VCLS · Boston, United States (Remote) · — · Posted 2026-06-29

**Workplace:** remote

**Department:** CMC

## Description

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

## Apply

[Apply at VCLS](https://apply.workable.com/vcls/j/D2AD01E679/apply)

---
Powered by [Workable](https://www.workable.com)