Senior Manager, Drug Substance

About the role

Are you a seasoned process chemist who enjoys working on drug substance projects? In this role, you will manage the chemical development and external manufacturing activities of our drug substance, working across programs in our pipeline spanning from late research through clinical trials and beyond. You will support drug substance development efforts toward IND filing and continue to support the journey from clinical trials to commercialization of our small molecule drug candidates.

Responsibilities

• Collaborate with the Discovery team and support the manufacturing of drug substances for DRF batches.
• Leverage technical expertise to lead or co-lead drug substance development programs, overseeing process development, scale-up, and manufacturing activities at global CRO and CDMO partners.
• Lead technical discussions with CDMOs, troubleshoot manufacturing challenges, and implement data-driven process improvements.
• Design and develop innovative, scalable, and commercially viable synthetic routes for complex small-molecule APIs.
• Provide regulatory compliance oversight at vendor sites during manufacturing campaigns.
• Define and implement phase-appropriate control strategies for raw materials and drug substance manufacturing, ensuring robust processes, consistent product quality, and alignment with regulatory expectations.
• Act as the key technical transfer resource, implementing optimized drug substance processes at vendors.
• Troubleshoot and solve synthetic, scale-up, and manufacturing issues.
• Author and review/approve specifications, batch records, development reports, manufacturing reports, and other critical technical documents.
• Collaborate with pharmaceutical development colleagues and external collaborators at CDMOs to advance projects.
• Author and review drug substance sections of regulatory submissions and technical documents, ensuring scientific accuracy and regulatory compliance.
• Travel domestically and/or internationally to accomplish critical objectives at vendor sites when necessary.

Requirements

• Ph.D. or equivalent with 5+ years of relevant process development, tech transfer, and/or manufacturing experience in pharmaceutical companies or contract manufacturing organizations (CMOs).
• Strong background in synthetic organic chemistry with demonstrated expertise in designing, developing, and optimizing synthetic routes for small molecule APIs.
• First-hand experience in process research, synthetic methodology development, impurity studies, and scale-up on pilot plant.
• Analytical skills including modern spectroscopic techniques (NMR, IR, mass spectroscopy, ReactIR, UV/Vis), separation techniques (HPLC, GC, TLC, flash chromatography, chiral separations), solid state characterizations, gravimetric analysis, and titration.
• Expertise in cGMP and strong knowledge of ICH, US FDA, and EMA quality guidelines.
• Ability to create high-quality written reports and common technical documents (CTD) sections for regulatory submissions.
• Excellent communication skills to collaborate effectively with contract laboratories, manufacturing facilities, and internal staff.
• Strong planning, organizational, and multitasking skills to prioritize in a highly dynamic environment.
• Demonstrated ability to work independently, prioritize tasks, and make scientifically sound decisions in a fast-paced pharmaceutical/biotechnology environment.

Preferred Qualifications

• Prior experience in managing CRO/CDMO (highly desirable but not mandatory).
• Experience in developing and applying innovative technologies, such as flow chemistry, biocatalysis, continuous manufacturing, and process analytical technologies (PAT) (highly desirable but not mandatory).

Pay

Estimated salary range: $122,000 – $174,000. The range provided is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on factors including education, experience, skills, and location.

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 and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets.