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Salary: USD 122,000 - 174,000 / annual
Relay Therapeutics seeks a Senior Manager, Drug Substance to lead chemical development and external manufacturing activities for small-molecule drug candidates across the pipeline, from late research through clinical trials and commercialization.
You will manage drug substance development efforts toward IND filing and beyond, collaborating with Discovery teams and overseeing process development, scale-up, and manufacturing at global CRO and CDMO partners. Key responsibilities include leading technical discussions with CDMOs, troubleshooting manufacturing challenges, implementing data-driven process improvements, and designing scalable synthetic routes for complex APIs.
You will define phase-appropriate control strategies for raw materials and drug substance manufacturing, ensuring robust processes and regulatory alignment. As the key technical transfer resource, you will implement optimized processes at vendor sites, author and review specifications, batch records, development reports, and regulatory submissions. You will also provide regulatory compliance oversight during manufacturing campaigns and travel domestically/internationally as needed.
Required qualifications: Ph.D. or equivalent with 5+ years of process development, tech transfer, and/or manufacturing experience in pharmaceutical companies or CMOs. Strong background in synthetic organic chemistry with expertise in designing and optimizing synthetic routes for small-molecule APIs. First-hand experience in process research, synthetic methodology development, impurity studies, and pilot-plant scale-up.
You must be proficient in modern analytical techniques (NMR, IR, mass spectrometry, ReactIR, UV/Vis, HPLC, GC, TLC, chiral separations, solid-state characterization). Expert knowledge of cGMP, ICH, US FDA, and EMA quality guidelines required. Strong scientific writing skills for regulatory submissions and CTD sections. Excellent communication, planning, and organizational skills with ability to work independently in dynamic environments. Prior CRO/CDMO management experience and innovative technology experience (flow chemistry, biocatalysis, continuous manufacturing, PAT) are highly desirable.
