CMC Consultant - Small Biotech

Senior CMC Consultant / Fractional Head of CMC

Location: Remote – UK or Europe

Employment Type: Contract / Part-Time

Contract Duration: Initial 12 Months (Potential Extension)

Commitment: Approximately 2–2.5 Days Per Week (Flexible)

Compensation: Competitive Hourly/Daily Rate – Open Depending on Experience

Start Date: ASAP

About the Opportunity

APX Life Sciences is partnering with an innovative, clinical-stage biotechnology company focused on developing novel therapies.

We are seeking a highly experienced Senior CMC Consultant / Fractional Head of CMC to provide strategic leadership and technical oversight across the company's ongoing clinical development programmes.

This is a senior-level consulting opportunity within a lean biotechnology environment, working closely with executive leadership to oversee CMC strategy, outsourced manufacturing, regulatory activities and future clinical development milestones.

The successful candidate will take ownership of the CMC function, managing external manufacturing partners and technical consultants while ensuring the company's drug development activities remain aligned with regulatory requirements and clinical timelines.

Key Responsibilities

• Lead and oversee the overall Chemistry, Manufacturing and Controls (CMC) strategy across clinical development programmes.
• Manage relationships with external Contract Development and Manufacturing Organisations (CDMOs) across the US and Europe.
• Provide technical oversight of drug substance (API) and drug product development, manufacturing and clinical supply activities.
• Oversee small-molecule formulation development, including oral liquid and capsule dosage forms.
• Provide strategic guidance on manufacturing processes, analytical development, stability, comparability and technical challenges.
• Lead and review regulatory CMC documentation, supporting IND, IMPD and future FDA/EMA submissions.
• Oversee external/ internal CMC specialists and technical consultants, ensuring quality and timely delivery of key programme milestones.
• Support GMP compliance, quality oversight and regulatory readiness across outsourced manufacturing activities.
• Identify and mitigate CMC-related risks, providing technical and strategic recommendations to senior leadership.
• Support the progression of clinical programmes from early-phase development towards later-stage clinical trials.

Candidate Requirements

• Extensive experience within Chemistry, Manufacturing and Controls (CMC), ideally operating at Senior Director, VP, Head of CMC or equivalent consulting level.
• Strong background in small-molecule pharmaceutical development, including drug substance and drug product manufacturing.
• Proven experience working within small or emerging clinical-stage biotechnology companies.
• Demonstrated ability to independently lead CMC activities within lean, outsourced operating models.
• Significant experience managing external CDMOs, manufacturing vendors and technical consultants.
• Strong understanding of FDA and EMA regulatory requirements, including CMC documentation for clinical trial applications and regulatory submissions.
• Experience supporting early-phase clinical development (Phase I/II), ideally with exposure to Phase IIb/III development.
• Knowledge of formulation development, process development, analytical methods, stability programmes and GMP manufacturing.
• Ability to provide both strategic CMC leadership and hands-on technical oversight.
• Excellent stakeholder management, communication and problem-solving skills.

Desirable Experience

• Previous experience operating as an independent CMC Consultant, Interim Head of CMC or Fractional CMC Leader.
• Experience with oral small-molecule formulations, including liquid and capsule dosage forms.
• Experience supporting manufacturing process changes, comparability assessments and bridging strategies.
• Experience supporting both US and European clinical development programmes.

Contract Details

This is an initial 12-month consulting engagement, with the potential for extension depending on programme requirements.

The anticipated commitment is approximately 2–2.5 days per week, although this may fluctuate depending on manufacturing activities, regulatory milestones and clinical development needs.

The position is fully remote, in the UK or Europe.

Hourly or daily rates are open and negotiable, depending on the successful candidate's experience and expertise.

How to Apply

Please apply directly through LinkedIn with an up-to-date CV, or contact jack@apxls.com for a confidential discussion.