Job Title
Associate Director Analytical Team Lead
Job Profile
Associate Director Analytical Team Lead','1303144',' Lead and direct Analytical Team Leaders (ATL) in coordinating analytical activities to support a world-class Biologics Analytical Development & Testing (ADT) organization. Help to establish and execute CMC timelines based on sound business and scientific analytical strategies through effective communication with multiple CMC groups within BMS and CMO/CRO organizations. Ensure timely delivery of analytical packages supporting all CMC activities for programs at all development stages.
This position is accountable for ensuring all analytical activities are well aligned with respective Integrated Development Teams (IDT) in executing IDT strategies. This would require effective communication with IDT members to establish strategies that are scientifically sound, phase appropriate, and achievable by required timelines. It also demands constant monitoring of all analytical development and testing activities to meet various CMC timelines. This position requires seasoned knowledge of current analytical methodologies to help select phase appropriate analytical methods. This role requires close collaboration with ADT groups and external departments, including teams in Discovery, Process Sciences, Drug Product Development and Manufacturing Sciences and Technology. This position reports to the Director of ADT office, within the Biologics Development organization of BMS’ Global Manufacturing and Supply (GMS) division.
This position will be directly accountable for all ATL related activities at all ADT sites (BLY, HPW, SYR, and Hopkinton) for programs from early through late development stages. This includes coordinating activities such as method development, technical transfer, release testing, extended characterization, comparability studies, reference standard qualification, formulation development, stability studies, regulatory filings, and sample distribution supporting above mentioned activities. This position will lead a team of scientists with both scientific and matrix team management skills. The candidate will strive for operational excellence and foster a continuous learning environment to develop future leaders in Analytical Team management.',' •PhD in biology, biochemistry, analytical chemistry or equivalent disciplines. •Minimum of 10 years experience in Biologics development. Extensive experience as a team leader managing analytical development of biologics including monoclonal antibodies, PEGylated proteins, and fusion proteins from various platforms. •Extensive experience in leading CMC project teams consisting of analytical, manufacturing, process development, quality, regulatory, supply chain etc. Experience in establishing development timelines, budgets and effective strategies to meet the clinical supply demands and supply chain resolution. •Extensive experience in analytical method development, validation, trouble shooting of biologics in various stages of development. Extensive experience in method transfer both nationally and internationally. Experience in due diligence activitiesto assess capacity and capability for global manufacturing (DS/DP) and analytical support. •Experience in oversight of CMOs for drug substance and drug product manufacturing and CROs for method development, characterization, validation and technology transfer in a fully compliant manner (domestic and international). •Experience in biologics process development and in-process analytical support. Experience in process control strategies to ensure process performance and product quality leading to process validation/process performance qualification. •Clear Understanding of ICH and other Health Authority guideline -','Process Development','NA-US-NJ-Hopewell','','Tech Op - Biologics Hopewell','Associate Director Analytical Team Lead
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Location: USA-NJ-Hopewell |
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Posted on
Aug 19,2026 |
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Company info
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