Your Role:
- You will lead and drive strategy for analytical method development and phase-appropriate method validation/transfer activities supporting full characterization of small molecule NCEs, from early development through late-stage/commercial readiness.
- Own the analytical strategy for drug substance programs at CDMOs, directing method development, validation, and troubleshooting to enable characterization, release, and stability testing of Relay clinical candidates.
- Provide senior-level review and approval of method transfer/validation protocols, data sets, and reports, ensuring scientific rigor and regulatory readiness.
- Hold accountability for QC testing oversight across analytical testing labs and DS manufacturing sites, including vendor performance and quality of deliverables.
- Review and approve method qualification protocols and reports at external laboratories, serving as the final scientific authority on method suitability.
- Direct the review and QC of raw data from third parties supporting batch release and stability; lead data trending efforts, proactively flag risks to the team, and drive resolution of issues.
- Manage a portfolio of concurrent projects, prioritizing resources and timelines across programs in a fast-paced, evolving environment.
- Serve as a cross-functional leader, partnering with CMC, Quality Assurance, and Regulatory Affairs to shape regulatory and development strategy, and representing Analytical Development in cross-functional and external-facing forums.
Your Background:
- Ph.D. in Analytical Chemistry, Biotechnology, or a related discipline with a minimum of 4+ years of relevant industry experience (or MS with 6+ years, or BS with 8+ years) in small molecule pharmaceutical analytical development.
- Demonstrated expertise leading analytical method development, validation, troubleshooting, and quality control programs, including experience directing work performed at external CMOs/CROs.
- Deep, hands-on analytical knowledge and technical authority in small molecule analytical methods for drug substance and solid-state characterization.
- Strong working expertise across analytical instrumentation including HPLC, GC, KF titration, XRPD, ICP-MS, UV, and solid-state characterization techniques, with the judgment to guide method selection and troubleshooting strategy.
- A confident, articulate communicator and cross-functional influencer, capable of representing Analytical Development with contract laboratories, manufacturing partners, and internal leadership.
- Proven ability to lead through ambiguity and shifting priorities in a fast-paced environment, balancing multiple high-visibility programs against firm timelines.
- Previous experience filing or working on IND and/or CTA filings is a plus.
- Strong command of regulatory and analytical guidelines, including cGMPs, ICH, FDA, USP, and other global regulatory requirements, with experience applying this knowledge to shape submission strategy.
Estimated Salary Range: [$121,000 - $172,000].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.
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About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
Relay Therapeutics Cambridge, Massachusetts, USA Office
399 Binney Street, 2nd Floor, Cambridge, MA, United States, 02139
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