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Head Of Cmc Jobs (NOW HIRING)

Neion Bio

Head of Biologics

Manhattan, NY · On-site

$170K - $230K/yr

We are looking for an exceptional Head of Biologics Development & CMC to lead the development of therapeutic proteins produced using Neion Bio's egg-based biomanufacturing platform. This person will ...

Takeda

Head, AIRx Biologics Discovery

Boston, MA · On-site

Purpose As the Head of AIRx Biologics Discovery, you will lead the end-to-end biologics discovery ... Strong understanding of biologic CMC considerations: expression systems (CHO, HEK), purification ...

Kivo, Inc

Head of Partnerships

We are hiring a Head of Partnerships to build and own that ecosystem. About the Role The Head of ... CMC. • Familiarity with eCTD, ICH guidelines (E6, M11, etc.), 21 CFR Part 11, EU Annex 11, or ...

Kivo

Head of Partnerships

Boston, MA · On-site

We are hiring a Head of Partnerships to build and own that ecosystem. About the Role The Head of ... CMC. • \tFamiliarity with eCTD, ICH guidelines (E6, M11, etc.), 21 CFR Part 11, EU Annex 11, or ...

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Head Of Cmc information

What are some typical challenges a Head of CMC faces when overseeing cross-functional development teams in pharmaceutical manufacturing?

As the Head of CMC (Chemistry, Manufacturing, and Controls), one common challenge is coordinating efforts between R&D, regulatory, quality assurance, and manufacturing teams to ensure alignment on timelines and compliance standards. Balancing innovative process development with strict regulatory requirements and managing resource constraints are also frequent hurdles. Effective communication and proactive project management are essential to navigate shifting priorities, address technical issues quickly, and keep all teams focused on delivering high-quality products within set deadlines.

What is the difference between Head Of Cmc vs Cmc Manager?

AspectHead Of CmcCmc Manager
ResponsibilitiesOversees entire CMC development, strategy, and regulatory compliance at a senior levelManages day-to-day CMC activities, ensuring project milestones and quality standards are met
Required CredentialsAdvanced degree in life sciences, extensive industry experience, leadership skillsBachelor's or Master's in related field, relevant industry experience
Work EnvironmentStrategic planning, cross-department collaboration, senior management meetingsOperational tasks, project management, team supervision

The Head Of Cmc typically holds a senior leadership role, focusing on strategic oversight and regulatory compliance, while the Cmc Manager handles daily operational activities. Both roles require relevant industry experience, but the Head Of Cmc's responsibilities are broader and more strategic.

What are the roles and responsibilities of a Head of CMC?

A Head of CMC (Chemistry, Manufacturing, and Controls) oversees all aspects of the drug development process related to manufacturing and quality. They are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled according to regulatory standards. This role involves leading cross-functional teams, managing relationships with external partners, and ensuring timely submission of regulatory documents. The Head of CMC also plays a key role in problem-solving, process optimization, and maintaining compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a Head of CMC, and why are they important?

To thrive as a Head of CMC (Chemistry, Manufacturing, and Controls), you need deep expertise in pharmaceutical development, regulatory requirements, and process optimization, typically supported by an advanced degree in chemistry, pharmacy, or a related field. Experience with quality management systems, regulatory submissions (e.g., IND, NDA, BLA), and industry-standard software such as LIMS or ERP platforms is essential. Strong leadership, strategic thinking, and cross-functional communication skills distinguish top performers in this role. These capabilities are critical for ensuring product quality, regulatory compliance, and the successful advancement of drug candidates through the development pipeline.
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Head Of Cmc jobs near you
Infographic showing various Head Of Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 16% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Head of Chemistry, Manufacturing, and Controls (CMC)

VCLS

Boston, MA • Remote

Full-time

Re-posted 7 days ago

Job 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