CMC Director
Paris, France | Hybrid Working | Specialty Pharmaceutical Company
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 CMC Director to provide strategic and technical leadership across a diverse portfolio of small and large molecule products .
Based in Paris, France , this hybrid leadership role offers the opportunity to influence the Chemistry, Manufacturing & Controls (CMC) strategy across multiple development programmes, 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 CMC Director, you will:
- Define and lead the global CMC strategy across a portfolio of small and large molecule development programmes.
- 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 CMC sections for global regulatory submissions, including INDs, IMPDs, CTAs, BLAs, NDAs and Marketing Authorisation Applications.
- 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 and biologic product development .
- Experience leading multidisciplinary development programmes through clinical development and commercialisation.
- Strong understanding of pharmaceutical development, process development, analytical development and manufacturing sciences.
- Experience working with global regulatory authorities and preparing CMC documentation for international submissions.
- 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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