Senior Drug Substance Development Lead

Relay Therapeutics; Cambridge (MA); On-site; USD 122,000 - 174,000; Full time

Job summary

Relay Therapeutics in Cambridge, MA is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations across programs from late research through clinical trials.

You will manage tech transfer to global CRO/CDMOs, design scalable routes, ensure cGMP compliance, and contribute to regulatory submissions with high-quality documentation.

Qualifications

• Ph.D. or equivalent with 5+ years in process development, tech transfer, and/or manufacturing.
• Strong background in synthetic organic chemistry for small-molecule APIs.
• Experience in process research, impurity studies, and pilot-scale up.
• Analytical skills with NMR, IR, MS, UV/Vis and chromatography.
• Expert in cGMP with knowledge of ICH, US FDA and EMA guidelines.
• Excellent scientific writing for regulatory submissions (CTD).
• Collaborates with contract labs and internal teams effectively.
• Excellent planning and multi-tasking in dynamic pharma setting.

Responsibilities

• Lead drug substance development toward IND filing.
• Collaborate with Discovery and manufacture DRF drug substances.
• Oversee process development, scale-up, and vendor manufacturing.
• Lead technical discussions with CDMOs and troubleshoot issues.
• Design innovative, scalable, and commercially viable syntheses.
• Ensure regulatory compliance at vendor sites during campaigns.
• Define control strategies for materials and drug substance manufacturing.
• Act as key technical transfer resource at vendor sites.
• Troubleshoot synthetic, scale-up, and manufacturing problems.
• Prepare specifications, batch records, and development reports.

Skills

Synthetic organic chemistry

Process development

Tech transfer

Scale-up

Regulatory knowledge (cGMP, ICH, FDA,/

Analytical techniques (NMR, IR, MS)

Technical writing (CTD)

CRO/CDMO collaboration

Planning & organization

Independent decision making

Education

Ph.D. in a relevant field

Tools

Flow chemistry

Biocatalysis

Continuous manufacturing

PAT

Job description

Relay Therapeutics in Cambridge, MA is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations across programs from late research through clinical trials.

You will manage tech transfer to global CRO/CDMOs, design scalable routes, ensure cGMP compliance, and contribute to regulatory submissions with high-quality documentation.