Senior Manager, Drug Product

Responsibilities

• Manage formulation and process development (R&D) activities to support clinical development pipeline programs
• Design and develop robust drug product formulation and manufacturing processes
• Oversee technical activities at drug product CMOs, including technology transfer and CTM production
• Assess and select appropriate packaging and container closure systems
• Design and develop R&D and GMP stability studies in collaboration with internal and third-party teams
• Author and review drug product sections of regulatory submission documents (IND, IMPD, NDA)
• Coordinate with analytical, quality, and supply chain teams to ensure timely manufacture and release of batches
• Provide person-in-plant support for drug product manufacturing activities at third parties

Requirements

• Master’s or advanced degree in Pharmaceutical Sciences, Chemistry, or related fields
• 6+ years of experience in formulation, product/process development, and scale-up
• Expertise in immediate release oral solid dosage forms (capsules, tablets)
• Experience with CMC/quality submissions including IND and IMPD
• Knowledge of current Good Manufacturing Practices (GMP)
• Knowledge of CMC quality guidelines (US, EU, JP, and ICH)
• Experience with DoE, CPPs, and design space identification

Preferred Qualifications

• Experience authoring CMC Modules 2 & 3 sections for NDAs/MAAs
• Experience in injectable product development

About the Company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion, the company aims to effectively drug protein targets that have previously been intractable.