Senior Manager, Drug Substance

Relay Therapeutics • Cambridge, MA

9d • $122,000 - $174,000

About The Position

This role is for a seasoned process chemist who enjoys working on drug substance projects and collaborating with pharmaceutical development teams and external collaborators to facilitate drug substance scale-up and manufacturing efforts. The Senior Manager, Drug Substance will be responsible for managing the chemical development and external manufacturing activities of drug substance, working across various programs in the pipeline from late research through clinical trials and beyond.

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 all 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.
• Proficiency in creating high-quality written reports and common technical documents (CTD) sections for use in regulatory submissions.
• Excellent communication skills, able to collaborate effectively with contract laboratories, manufacturing facilities, and internal staff.
• Excellent planning and organizational skills, with the ability to multi-task and 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.

Nice To Haves

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

Responsibilities

• Support drug substance development efforts toward IND filing and continue to support the journey from clinical trials to commercialization of small molecule drug candidates.
• 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 in the implementation of 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 other pharmaceutical development colleagues and external collaborators at CDMOs to advance the project.
• 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 the vendor’s site, when necessary.

Benefits

• Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree