We’re hiring a Technical CMC Director with deep expertise in small molecule API commercial manufacturing and prior experience working with CDMOs. This role provides technical leadership and oversight for GMP operations, ensuring quality, compliance, and regulatory readiness.
This role is highly hands-on, focused on writing, reviewing, and approving GMP batch documentation, managing Quality System activities (CAPAs, deviations, change controls), and contributing technical and regulatory input for small molecule CMC submissions.
The successful candidate will bring a deep understanding of GMP operations, API production processes, and regulatory expectations, combined with strong technical writing skills and attention to detail.
Key Responsibilities
GMP Documentation
* Write, review, and approve GMP production documentation, including master batch records, protocols, and reports.
* Ensure all documentation is accurate, compliant with cGMP standards, and easily executable by manufacturing operators.
* Harmonize documentation and processes across multiple CDMOs to ensure consistency and standardization.
* Act as the technical subject matter expert for production documentation reviews and approvals.
Quality Systems & Compliance
* Lead or support CAPA, deviation, and change control activities related to small molecule API manufacturing.
* Conduct and document thorough root cause analyses and implement effective corrective and preventive actions.
* Collaborate closely with Quality Assurance and CMO teams to maintain regulatory and quality compliance across all manufacturing sites.
Regulatory & CMC Support
* Provide technical input into the CMC (Module 3) sections of regulatory submissions for small molecule APIs.
* Support new product introductions (NPIs) and new submission filings for global regulatory agencies (FDA, EMA, and other regional authorities).
* Help explain and rationalize manufacturing process differences across CDMOs during regulatory review and inspections.
* Contribute to the preparation of responses to Health Authority questions.
Technical Leadership & Collaboration
* Serve as a key technical contact with external CDMOs, ensuring process understanding and compliance.
* Work cross-functionally with internal Quality, Regulatory, and Supply Chain teams to ensure product readiness and supply continuity.
* Translate technical manufacturing information into compliant, clear, and user-friendly GMP documentation.
* Mentor and guide team members as needed, promoting best practices in GMP operations and documentation.
Required Qualifications & Experience
Education:
* PhD in Chemistry preferred; MSc or BSc in Chemistry, Pharmaceutical Sciences, or related scientific discipline will also be considered.
Experience:
* Minimum 10 years’ experience in GMP small molecule API manufacturing.
* Proven, hands-on experience writing, reviewing, and approving GMP batch records and production documentation (not just oversight).
* Practical involvement in Quality Systems: CAPAs, deviations, and change controls, including leading investigations.
* Experience supporting CMC submissions and contributing to regulatory filings (Module 3).
* Prior experience working within or closely with CDMOs, with solid understanding of manufacturing workflows and batch record structures.
* Familiarity with FDA and EMA regulatory requirements; additional exposure to LATAM or JAPAC markets is an advantage.
Interested? Apply now for immediate consideration or contact Lloyd Broomes on +44 203 928 8386 – LBroomes@planet-pharma.co.uk
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.