Head of Drug Product Development & CMC

Relay Therapeutics; Cambridge (MA); On-site; USD 143,000 - 203,000; Full time

Job summary

Relay Therapeutics is seeking a senior drug product leader to drive pediatric and general formulation development and scalable manufacturing processes. You will manage outsourcing to global CRO/CMO partners, ensure robust CMC documentation, and support IND/NDA submissions in collaboration with AD/QC, QA and regulatory teams.

You will draft specifications, approve batch records, and contribute to technology transfer strategies while working across cross-functional program teams to meet project

Qualifications

• Advanced degree with 8–10 years in oral solid formulations and manufacturing process development.
• Experience with pediatric formulation concepts, excipients, and packaging configurations.
• Experience with palatability assessment, taste masking, and in-use stability/food compatibility.

Responsibilities

• Lead design, development and optimization of pediatric and general drug product formulations and manufacturing processes.
• Oversee outsourcing to global CRO/CMO sites, aligning with program goals.
• Draft and review specifications, batch records, and GMP documents; support regulatory submissions (IND/NDA).
• Collaborate with cross-functional teams to ensure successful tech transfer to manufacturing sites.

Skills

Formulation development

Drug product development

CMC knowledge

DoE / QbD

Regulatory submissions

Education

PhD in Pharmaceutics / Pharmaceutical Sciences

Job description

Relay Therapeutics is seeking a senior drug product leader to drive pediatric and general formulation development and scalable manufacturing processes. You will manage outsourcing to global CRO/CMO partners, ensure robust CMC documentation, and support IND/NDA submissions in collaboration with AD/QC, QA and regulatory teams.

You will draft specifications, approve batch records, and contribute to technology transfer strategies while working across cross-functional program teams to meet project