Director, Analytical Development and Quality Control

The Opportunity 

We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. 

You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. 

This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline. 

 

Your Role 

• You will be responsible for setting and executing the analytical development and quality control strategy across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development. 

• You will lead analytical method development, validation, and lifecycle management activities required for the full characterization of small molecule NCEs. 

• You will provide scientific and strategic oversight of external laboratories, CMOs, and CROs conducting analytical development, method validation, release testing, and stability testing in support of Relay clinical candidates. 

• You will review and approve analytical development strategies, method transfer and validation protocols, datasets, and final reports. 

• You will oversee QC testing performed at external analytical laboratories and DS/DP manufacturing sites to ensure compliance with cGMP standards. 

• You will provide quality oversight and approval of cGMP QC documentation, including change controls, deviations, CAPAs, analytical procedures, and validation protocols. 

• You will review analytical data packages and raw data from third-party laboratories to support batch disposition and release. 

• You will oversee the Reference Standard program, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories. 

• You will lead activities related to critical quality attributes (CQAs), specifications, stability strategies, data trending, shelf life determinations, and expiry dating for drug substance and drug product. 

• You will define and implement phase-appropriate analytical and stability strategies across all clinical development programs. 

• You will author and review QC and analytical sections of regulatory filings, including INDs and NDAs, and provide technical leadership for responses to Health Authority questions. 

• You will represent the analytical function in cross-functional program teams and contribute to overall CMC strategy and regulatory planning. 

• You will build strong partnerships across Regulatory Affairs, CMC, Quality Assurance, and external partners to ensure alignment on development and regulatory strategies. 

• As the analytical function grows, you may mentor and lead internal scientists or matrix teams, while establishing scalable processes and best practices. 

 

Your Background 

• You have earned an MS or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or a related discipline, with 10+ years of industry experience, including significant experience leading analytical development activities in a pharmaceutical or biotechnology environment. 

• You have deep expertise in analytical development, method validation, technology transfer, troubleshooting, and quality control for small molecule drug development.<