CMC Director

Small Molecule | Late-Stage Development | Commercialisation | United States

Allerton Bishop is supporting a global biotech to appoint an CMC Director. This is a senior technical position responsible for Drug Product activities across late-stage clinical development, regulatory submission, validation and commercial readiness
.

The successful candidate will combine strong small molecule Drug Product expertise with the ability to provide strategic CMC leadership, manage external manufacturing partners and support global regulatory submissions.

• Lead the Drug Product CMC strategy through late-stage development and commercialisation.
• Provide technical leadership across formulation, manufacturing, packaging, stability and product supply.
• Manage and provide technical oversight of external CDMOs and manufacturing partners
  .
• Lead manufacturing troubleshooting, technical investigations and process improvements.
• Oversee process characterisation, PPQ, validation and technology transfer activities.
• Ensure manufacturing processes and control strategies are suitable for regulatory approval and commercial supply.
• Support Drug Product forecasting, manufacturing campaigns and supply continuity.
• Provide Drug Product CMC input into IMPD/IND and NDA/MAA submissions
  .
• Contribute to the preparation and review of Module 3 regulatory documentation and responses to Health Authority questions.
• Work closely with Regulatory CMC, Quality, Supply Chain, Analytical Development, Drug Substance and Clinical teams.
• Manage Drug Product budgets, timelines and external partner performance.
• Support ongoing lifecycle management and continuous improvement activities.

• Significant pharmaceutical or biotechnology industry experience.
• Strong small molecule Drug Product development expertise.
• Experience with oral solid dose products.
• Experience taking products through late-stage clinical development, validation and regulatory submission
  .
• Hands-on experience supporting or authoring NDA and/or MAA CMC documentation
  , ideally including Module 3.
• Demonstrable experience managing CDMOs/CMOs and outsourced manufacturing activities
  .
• Experience taking a product through commercial launch.

CMC Director | Director CMC | Director Drug Product | Director of Drug Product | Drug Product Director | Senior Director Drug Product | Senior Director CMC | Head of Drug Product | Head of CMC | Director Pharmaceutical Development | Director Formulation Development | CMC Lead | Drug Product Lead | Drug Product | CMC | Small Molecule | Oral Solid Dose | OSD | Tablets | Capsules | Formulation | Pharmaceutical Development | Phase III | Late-Stage Development | NDA | MAA | IMPD | IND | Module 3 | Regulatory CMC | Commercialisation | PPQ | Process Validation | Technology Transfer | CDMO | CMO | External Manufacturing | GMP | Pharmaceutical Manufacturing | Biotech