Head of CMC Small Molecule

Life - Science Talent Matchmaker | Drug Discovery, CMC & MSAT Global Staffing Expert | Senior Consultant at BioTalent

Head of CMC - Small Molecule

Location :

Must be based in the UK, Switzerland, the Netherlands, or Germany .

If based near Cambridge (UK) , this role involves around 2 days per week in the office .

If based elsewhere in the UK or EU (Switzerland, the Netherlands, or Germany) , travel to Cambridge will be required approximately every 6 weeks .

Type : Full-time, hybrid

Includes : Private Medical Insurance, Pension Scheme, Life Assurance, Cycle to Work Scheme, and 25 Days Holiday (plus bank holidays)

About the Company

This fast-growing, venture-backed biotech is entering one of the most exciting phases of its journey. Operating in stealth mode and finalising a major Series A with leading international investors, the company is building a new class of therapies aimed at transforming the treatment of complex inflammatory and immunological diseases.

Led by a proven scientific and operational team, they've already advanced their lead programme to Phase 2 and are now investing in the internal structure needed to take their pipeline confidently through development and into commercialisation.

The company's culture is deliberately small, close-knit, and highly collaborative. Decisions are made quickly, and egos are left at the door. Every person here has a real voice and a visible impact on the company's success. For anyone tired of the bureaucracy of big pharma, this is a chance to join early, shape the foundations of a serious biotech, and help steer its technical future.

The Opportunity

This is a senior, hands‐on leadership role for an experienced CMC professional who can combine strategic vision with practical execution. You'll have end‐to‐end ownership of CMC activities for Small Molecules , covering Drug Substance (DS), Drug Product (DP), analytical development, GMP manufacturing, and clinical supply.

You'll be the company's internal CMC authority, responsible for building the function from the ground up, selecting and managing CDMOs, and ensuring all regulatory deliverables are met to support IND / IMPD submissions and ongoing clinical development. It's a rare greenfield position with real autonomy, reporting directly to the COO and working closely with the VP of Preclinical Development.

Key Responsibilities

Define and deliver the company's overall CMC strategy from late pre‐clinical through commercial stages.

Build and manage CMC capability, combining internal oversight with expert external partners.

Lead DS / DP development, analytical validation, and stability studies.

Oversee GMP manufacturing, tech transfer, and process scale‐up through CDMOs.

Lead preparation and authorship of CMC sections for IND / IMPD / CTA filings.

Drive Module 3 readiness for validation and registration batches.

Manage packaging, labelling, and clinical trial supply logistics.

Select and negotiate with CDMOs / CROs (including current partners).

Maintain oversight of budgets, timelines, and compliance.

Present strategy and progress at senior leadership and board level.

What You'll Bring

PhD or MSc / BSc in Chemistry, Biochemistry, or related discipline.

10+ years of experience in CMC or Pharmaceutical Development.

Proven leadership of DS / DP development, scale‐up, and GMP manufacturing.

Strong experience managing multiple CDMOs and external suppliers.

Direct authoring or oversight of IND / IMPD submissions (Module 3).

Solid technical grounding in analytical validation and stability studies.

Demonstrated success leading validation and registration batches.

Collaborative, pragmatic, low‐ego leadership style suited to lean environments.

Based in the UK, Switzerland, the Netherlands, or Germany, with flexibility to travel to Cambridge every 6 weeks.

Why Apply

This is a career‐defining role for a senior CMC leader who wants more than a corporate title. You'll join an ambitious, well‐funded biotech early enough to make your mark, but established enough to move fast and deliver.

If you're motivated by the idea of building something from scratch, working closely with world‐class scientists, and having your expertise directly shape a company's trajectory, this is the opportunity to do it.

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