Workforce Genetics is looking for a Director, CMC based in Rockville, MD.

Position Summary

The Director, CMC will oversee and manage Contract Manufacturing Organizations (CMOs) specializing in sterile fill/finish operations, ensuring the delivery of robust, scalable, and cost-effective drug products that meet or exceed clinical and regulatory standards. This role is critical for process transfer, regulatory compliance, and technical oversight of drug substance (DS) and drug product (DP) manufacturing.

Key Responsibilities

• Direct the day-to-day management of CMOs, ensuring efficient sterile fill/finish operations.

• Lead DS/DP process transfer from laboratory to clinical-scale manufacturing.

• Coordinate technical, operational, supply chain, quality, and business aspects to ensure successful clinical trial material (CTM) delivery.

• Establish and review batch manufacturing records, specifications, CoAs, deviations, and change controls.

• Ensure alignment with cGMP (MHRA, FDA, EMA) regulatory requirements for biologics and pharmaceuticals.

• Oversee ICH stability studies and shelf-life specifications in collaboration with subject matter experts.

• Act as internal CMC lead, projecting API and DP needs for preclinical and clinical programs.

• Develop and negotiate MSAs, SOWs, contracts, and purchase orders in collaboration with Procurement, Legal, and Finance teams.

• Play a key role in Module 3 CTD authoring for regulatory submissions.

• Proactively identify efficiencies, corrective actions, and process improvements.

• Monitor emerging regulatory trends and industry best practices to advise internal teams.

Qualifications & Experience

• BSc, MSc, or PhD in Life Sciences, Biopharmaceuticals, or related field.

• 10+ years in CMC activities, including clinical candidate transfer from laboratory to manufacturing.

• Proven expertise in ICH stability study management, vaccine drug product development, and cGMP regulations (MHRA, FDA, EMA).

• Experience in RNA vaccine development, including formulation, characterization, and regulatory submissions.

• Strong understanding of CMC development, CDMO management, and GMP-compliant manufacturing for RNA-based products. 

• Strong knowledge of biopharmaceutical drug development and manufacturing processes.

Skills

• Strategic decision-making and problem-solving abilities.

• Strong cross-functional collaboration skills.

• Commitment to process optimization and continuous improvement.

• Effective communication and leadership abilities.