Drug Substance Development Lead

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

Job summary

Relay Therapeutics is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations with CROs and CDMOs in support of IND filing and clinical programs.

You will design scalable synthetic routes for small-molecule APIs, oversee process development, and ensure regulatory compliance while delivering robust, high-quality drug substance manufacturing at partnered facilities worldwide.

Qualifications

• Ph.D. or equivalent with 5+ years of process development, tech transfer, or manufacturing experience in pharma or CMOs.
• Strong background in synthetic organic chemistry with experience designing and optimizing routes for small molecule APIs.
• Experience with regulatory guidelines (cGMP, ICH, FDA/EMA) and writing regulatory documents.
• Proven ability to collaborate with CROs/CDMOs and internal teams to advance programs.

Responsibilities

• Lead or co-lead drug substance development programs, including process development, scale-up, and manufacturing activities at global CRO/CDMO partners.
• Design scalable, innovative synthetic routes for complex APIs and oversee transfer to vendor sites.
• Lead technical discussions with CDMOs, troubleshoot manufacturing challenges, and implement data-driven improvements.
• Prepare and review specifications, batches, development and manufacturing reports, and CTD sections.
• Collaborate with Discovery and regulatory teams and support IND filings and regulatory submissions.

Skills

Process development

Tech transfer

Synthetic organic chemistry

Analytical techniques

Regulatory compliance

Scientific writing

Project management

Education

Ph.D. or equivalent

Tools

HPLC

NMR

MS

TLC

IR

Job description

Relay Therapeutics is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations with CROs and CDMOs in support of IND filing and clinical programs.

You will design scalable synthetic routes for small-molecule APIs, oversee process development, and ensure regulatory compliance while delivering robust, high-quality drug substance manufacturing at partnered facilities worldwide.