Senior Manager, Analytical Development & QC

Job Description:

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.
• Lead the evaluation and introduction of modern analytical technologies, setting direction for how new techniques are incorporated into method development workflows across programs.
• 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 8+ years of relevant industry experience (or MS with 10+ years, or BS with 12+ 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: [$140,000-$200,000].

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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