Lead the development of innovative medicines from concept to commercialisation.
Allerton Bishop is proud to be partnering with an innovative specialty pharmaceutical company as they appoint a Head of CMC to provide strategic and technical leadership across late stage portfolio of small molecule products.
Based in England, this hybrid leadership role offers the opportunity to influence the Chemistry, Manufacturing & Controls (CMC) strategy for a critical asset, working closely with global development, regulatory, quality and manufacturing teams.
This is an outstanding opportunity for an experienced CMC leader who enjoys combining scientific expertise with programme leadership, driving products through development while ensuring robust manufacturing and regulatory strategies.
Responsibilities
As Head of CMC, you will:
- Define and lead the global CMC strategy across a portfolio of small molecule products..
- Provide strategic oversight from early development through to commercial manufacture and lifecycle management.
- Lead cross-functional CMC teams spanning Pharmaceutical Development, Analytical Development, Process Development, Manufacturing, Quality and Regulatory Affairs.
- Drive technical development activities, ensuring programmes remain aligned to key development milestones.
- Oversee NDA submissions with the FDA
- Provide scientific leadership throughout technology transfer, process validation, scale-up and commercial manufacturing.
- Collaborate with external CDMOs and manufacturing partners to ensure successful product development and supply.
- Identify technical and regulatory risks while implementing robust mitigation strategies.
- Support due diligence, portfolio expansion and business development opportunities from a CMC perspective.
- Represent CMC within senior governance meetings, providing strategic direction to executive leadership.
Candidate Profile
We are seeking an experienced pharmaceutical development leader with strong technical knowledge across Chemistry, Manufacturing & Controls.
You will demonstrate:
- Significant experience within CMC leadership in the pharmaceutical, biotechnology or specialty pharmaceutical industry.
- Strong knowledge of both small molecule product development.
- Experience leading multidisciplinary development programmes through clinical development and commercialisation.
- Strong understanding of pharmaceutical development, process development, analytical development and manufacturing sciences.
- Prior experience taking a molecule from PhIII through regulatory approval with the FDA
- Demonstrated success managing external CDMOs and strategic manufacturing partnerships.
- Excellent programme leadership and cross-functional stakeholder management skills.
- Strong understanding of GMP, ICH guidelines and pharmaceutical regulatory requirements.
- Degree in Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Sciences or a related scientific discipline. A PhD is advantageous.
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