CMC Director

Allerton Bishop Search; Massachusetts; On-site; USD 240,000 - 360,000; Full time

Job summary

Allerton Bishop is seeking a senior CMC Director to lead Drug Product CMC strategy across late-stage development and commercialisation in the United States. The role requires strategic leadership, oversight of external CDMOs/CMOs, and collaboration with Regulatory CMC, Quality and Clinical teams.

The successful candidate will drive regulatory submissions (NDA/MAA), manage budgets, and ensure robust processes for commercial supply, process validation and technology transfer.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Small molecule Drug Product

Oral solid dose

Late-stage development

Regulatory submissions

NDA/MAA CMC documentation

CDMOs/CMOs management

Commercial launch

CMC leadership

Job description

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.

Key Responsibilities:

• 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.

Requirements:

• 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