Lead, Analytical Development & QC Strategy

Relaytherapeutics; Cambridge (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Relay Therapeutics in Cambridge, MA seeks an experienced analytical development leader to drive method development, validation, and transfer for small molecule programs from discovery through late-stage readiness.

You will own the analytical strategy for drug substances, manage CMOs/CROs, and ensure robust characterization, release, and stability testing across programs while collaborating with CMC, QA, and Regulatory Affairs.

Qualifications

• Ph.D. in Analytical Chemistry, Biotechnology, or related field.
• 8+ years of relevant industry experience in small molecule analytical development.
• Experience leading analytical method development, validation, troubleshooting, and QC programs, including directing work at CMOs/CROs.
• Strong command of regulatory guidelines (cGMP, ICH, FDA, USP) and ability to shape submission strategies.

Responsibilities

• Lead strategy for analytical method development and phase-appropriate validation/transfer activities for small molecule NCEs.
• Own analytical strategy for drug substance programs at CMOs/CROs, directing method development, validation, and troubleshooting.
• Lead evaluation and adoption of modern analytical technologies in development workflows.
• Review and approve validation protocols and data reports ensuring regulatory readiness.
• Oversee QC testing and vendor performance across labs and DS manufacturing sites.
• Direct the review and QC of raw data from third parties supporting batch release and stability; lead data trending and risk mitigation.
• Manage a portfolio of concurrent projects, prioritizing resources and timelines across programs in a fast-paced environment.
• Represent Analytical Development in cross-functional forums with CMC, QA, and Regulatory Affairs.

Skills

Analytical method leadership

Cross-functional leadership

Regulatory readiness

IND/CTA filings

Data trend analysis

Education

Ph.D. in Analytical Chemistry or related field

8+ years in small molecule analytical development

Tools

HPLC

GC

XRPD

ICP-MS

KF titration

UV

Job description

Relay Therapeutics in Cambridge, MA seeks an experienced analytical development leader to drive method development, validation, and transfer for small molecule programs from discovery through late-stage readiness.

You will own the analytical strategy for drug substances, manage CMOs/CROs, and ensure robust characterization, release, and stability testing across programs while collaborating with CMC, QA, and Regulatory Affairs.