Director, CMC (Chemistry, Manufacturing & Controls)
Location: UK
Stage: Early-stage biotech (preclinical → IND)
Modality: Antibody-Drug Conjugates (ADCs) in oncology
Company Overview
Hartmann Young are partnered with an early-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for oncology, with a primary focus on colorectal cancer. Their lead programme targets LGR5, a biologically validated but historically challenging target, where they have developed a differentiated approach to unlock selective tumour targeting.
Role Overview
They are seeking a Director of CMC to lead all aspects of Chemistry, Manufacturing & Controls strategy and execution, supporting their lead ADC programme through IND-enabling activities and into early clinical development.
This is a high-impact, hands-on leadership role in a lean organisation, requiring both strategic oversight and operational delivery across biologics and conjugated drug product development.
Key Responsibilities
- CMC Strategy & Leadership
- Define and execute the CMC development strategy for ADC programmes from preclinical through IND and early clinical stages
- Serve as the CMC lead on cross-functional programme teams, contributing to overall asset strategy
- Process Development & Manufacturing
- Oversee development and scale-up of antibody, linker-payload, and conjugation processes
- Manage external CDMOs across drug substance and drug product manufacturing
- Ensure robust process characterisation and comparability strategies
- Analytical & Quality
- Guide development of analytical methods for ADC characterisation (e.g. DAR, potency, impurities)
- Ensure appropriate quality control and release testing strategies
- Partner closely with QA to ensure GMP compliance
- Regulatory Support
- Lead preparation of CMC sections for regulatory submissions (IND/CTA)
- Act as the primary CMC interface with regulatory authorities
- Vendor & Project Management
- Select, manage, and oversee CDMOs, CROs, and supply partners
- Drive timelines, budgets, and risk mitigation strategies
- Supply Chain
- Ensure clinical supply readiness, including drug substance, drug product, and packaging/labeling
Candidate Profile
- Advanced degree (PhD preferred) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- Significant CMC experience in biologics; direct ADC experience strongly preferred
- Proven track record supporting IND/CTA filings and early clinical development
- Deep understanding of antibody production, linker-payload chemistry, and conjugation processes
- Experience managing CDMOs in a virtual/outsourced model
- Strong working knowledge of GMP and regulatory expectations for CMC
Key Attributes
- Hands-on, execution-focused leader comfortable in a lean startup environment
- Strong scientific depth combined with pragmatic decision-making
- Ability to operate with high ownership and accountability
- Excellent cross-functional collaboration and communication skills
Opportunity
- Lead CMC for a differentiated ADC platform targeting a high-value, biologically validated target
- Shape development strategy at an early stage with meaningful scientific ownership
- Join a focused, high-calibre team working at the cutting edge of tumour-targeted therapies
…