Associate Director, Drug Product
Relay Therapeutics
August 19, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Lead and be an integral part of Relay’s drug product development team supporting development programs.
- Design, develop, and optimize patient-centric (e.g., pediatric) drug product formulation and clinical/commercially viable manufacturing processes, including selection of appropriate packaging (container closure systems).
- Lead and manage outsourcing (formulation/product development and manufacturing) at global CRO/CMO sites aligned with program goals.
- Manage prototype development/feasibility assessment and clinical manufacturing activities.
- Support formulation/drug product R&D and GMP stability studies with internal AD/QC, QA, and third parties.
- Serve as key drug product SME for technology transfer to manufacturing site(s), providing technical input to CMOs.
- Draft, review, and approve specifications, batch records, and other critical development/GMP documents.
- Author/review drug product sections of CMC regulatory submissions (IND, IMPD, NDA, PIP, iPSP, briefing packages), regulatory responses, and supporting documentation.
- Collaborate cross-functionally to meet program/project objectives and OKRs.
- Evaluate and implement new sustainable drug product technologies for pipeline products and lifecycle management.
Qualifications:
- Advanced degree (PhD/doctoral or post-doctoral) in Pharmaceutics/Pharmaceutical Sciences or related field; 8–10+ years industry experience.
- Proven experience in oral solids (granules, minitablets, powders for reconstitution, capsules) and liquid suspension formulations; manufacturing process development/optimization and scale-up.
- Pediatric product development fundamentals (excipients, dosage form, packaging configuration).
- Palatability assessment/taste masking and in-use stability/food compatibility (desirable).
- Strong understanding of phase-appropriate IR oral formulations and pharmaceutical product development.
- Experience identifying CPPs, design space, DoE, and statistical programs.
- cGMP knowledge; development of new chemical entities under cGMP.
- CMC quality guidelines knowledge (US/EU/JP/ICH).
- Ability to author/review technical reports for IND/NDA, regulatory compliance, and IP.
- Strong organization, multitasking/prioritization, problem-solving, and ability to work under pressure.
- Strategic thinking, communication, leadership, planning, and collaboration.
- Exceptional attention to detail and ability to work with internal and third-party teams.
Estimated salary range: $143,000 - $203,000.
- Lead and be an integral part of Relay’s drug product development team supporting development programs.
- Design, develop, and optimize patient-centric (e.g., pediatric) drug product formulation and clinical/commercially viable manufacturing processes, including selection of appropriate packaging (container closure systems).
- Lead and manage outsourcing (formulation/product development and manufacturing) at global CRO/CMO sites aligned with program goals.
- Manage prototype development/feasibility assessment and clinical manufacturing activities.
- Support formulation/drug product R&D and GMP stability studies with internal AD/QC, QA, and third parties.
- Serve as key drug product SME for technology transfer to manufacturing site(s), providing technical input to CMOs.
- Draft, review, and approve specifications, batch records, and other critical development/GMP documents.
- Author/review drug product sections of CMC regulatory submissions (IND, IMPD, NDA, PIP, iPSP, briefing packages), regulatory responses, and supporting documentation.
- Collaborate cross-functionally to meet program/project objectives and OKRs.
- Evaluate and implement new sustainable drug product technologies for pipeline products and lifecycle management.
Qualifications:
- Advanced degree (PhD/doctoral or post-doctoral) in Pharmaceutics/Pharmaceutical Sciences or related field; 8–10+ years industry experience.
- Proven experience in oral solids (granules, minitablets, powders for reconstitution, capsules) and liquid suspension formulations; manufacturing process development/optimization and scale-up.
- Pediatric product development fundamentals (excipients, dosage form, packaging configuration).
- Palatability assessment/taste masking and in-use stability/food compatibility (desirable).
- Strong understanding of phase-appropriate IR oral formulations and pharmaceutical product development.
- Experience identifying CPPs, design space, DoE, and statistical programs.
- cGMP knowledge; development of new chemical entities under cGMP.
- CMC quality guidelines knowledge (US/EU/JP/ICH).
- Ability to author/review technical reports for IND/NDA, regulatory compliance, and IP.
- Strong organization, multitasking/prioritization, problem-solving, and ability to work under pressure.
- Strategic thinking, communication, leadership, planning, and collaboration.
- Exceptional attention to detail and ability to work with internal and third-party teams.
Estimated salary range: $143,000 - $203,000.