Discover International
Director / Associate Director – Analytical Development (Biologics, LC-MS, HPLC)
Discover International, Raleigh, North Carolina, United States
Director / Associate Director – Analytical Development (Biologics, LC‑MS, HPLC)
We're supporting a leading biologics CDMO in the Research Triangle area that’s expanding its Analytical Development organization. About the Role The Director (or Associate Director) of Analytical Development will lead cross‑functional laboratory teams focused on biologics characterization and method development. This role requires a balance of scientific depth, operational leadership, and client engagement. Key Responsibilities Lead and mentor teams across HPLC/UPLC, LC‑MS, CE, and Bioassay platforms. Oversee method development, qualification, transfer, and validation in support of GMP testing. Partner with internal groups and clients on analytical strategies, timelines, and troubleshooting. Serve as subject‑matter expert (SME) in LC‑MS and HPLC‑based bioseparation techniques. Ensure compliance with ICH / GMP / FDA requirements and company quality systems. Drive lab efficiency, innovation, and scientific excellence. Represent analytical development in regulatory discussions, client audits, and project meetings. Required Background M.S. or Ph.D. in Chemistry, Biochemistry, or related field. 8–15 years of analytical development experience within biologics or gene‑therapy programs. Proven expertise with LC‑MS, HPLC/UPLC, and bioseparation methods (SEC, IEX, RP‑HPLC, CE‑SDS, etc.). Prior leadership of analytical teams in a CDMO / biotech/pharma setting. Strong understanding of GMP expectations, method lifecycle, and CMC deliverables. Excellent communication and client‑facing skills. Why Join Fast‑growing biologics site investing heavily in analytical innovation. Direct influence on strategy, operations, and client success. Competitive package + relocation support (if needed).
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We're supporting a leading biologics CDMO in the Research Triangle area that’s expanding its Analytical Development organization. About the Role The Director (or Associate Director) of Analytical Development will lead cross‑functional laboratory teams focused on biologics characterization and method development. This role requires a balance of scientific depth, operational leadership, and client engagement. Key Responsibilities Lead and mentor teams across HPLC/UPLC, LC‑MS, CE, and Bioassay platforms. Oversee method development, qualification, transfer, and validation in support of GMP testing. Partner with internal groups and clients on analytical strategies, timelines, and troubleshooting. Serve as subject‑matter expert (SME) in LC‑MS and HPLC‑based bioseparation techniques. Ensure compliance with ICH / GMP / FDA requirements and company quality systems. Drive lab efficiency, innovation, and scientific excellence. Represent analytical development in regulatory discussions, client audits, and project meetings. Required Background M.S. or Ph.D. in Chemistry, Biochemistry, or related field. 8–15 years of analytical development experience within biologics or gene‑therapy programs. Proven expertise with LC‑MS, HPLC/UPLC, and bioseparation methods (SEC, IEX, RP‑HPLC, CE‑SDS, etc.). Prior leadership of analytical teams in a CDMO / biotech/pharma setting. Strong understanding of GMP expectations, method lifecycle, and CMC deliverables. Excellent communication and client‑facing skills. Why Join Fast‑growing biologics site investing heavily in analytical innovation. Direct influence on strategy, operations, and client success. Competitive package + relocation support (if needed).
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