ANALYTICAL TEAM LEAD(Job Number: 1304669)
Provide leadership to Analytical Project Teams within and across functional areas that coordinates analytical activities to support a world-class Biologics Analytical Development & Testing (ADT) organization. Help to establish project specific CMC timelines based on sound business and scientific strategies through effective communication with multiple CMC groups within BMS and CMO/CRO organizations. Ensure timely delivery of project specific analytical packages supporting CMC activities. The candidate will be required to interface ADT with multiple organizations across CMC organizations within BMS, as well as CMO/CRO organizations.
This position is accountable for ensuring all project analytical activities are well aligned with the respective Integrated Development Team (IDT) in executing the IDT strategies. This position would require effective communication with IDT members and Analytical Department Leadership in establishing sound analytical strategies and execution plans that meet business needs, are phase appropriate, and delivered by the required timeline. The position requires constant monitoring of all project specific analytical development and testing activities. This position also requires a breadth and depth of knowledge of current analytical techniques and methodologies in biologics to help select and monitor phase appropriate analytical methods. The Analytical Team Leader will lead a matrix team of analysts, managing programs from preclinical development through global registrational filings. This role requires close collaboration within ADT groups and external departments, including teams in Process Sciences, Drug Product Science and Technology, Manufacturing Sciences and Technology, Clinical Supply Organization, Drug Safety Evaluation, and CMC-Regulatory. The ATL position reports to the Associate Director of Analytical Team Leaders in ADT Office, within the Biologics Development organization of BMS’ Global Manufacturing and Supply (GMS) division.
- MS or PhD in biology, biochemistry, analytical chemistry or equivalent discipline.
- Minimum of 4-10 years extensive method development experience in Biologics development.
- Strong knowledge of Biochemical principles, Chromatography, Electrophoresis, Protein chemistry
- Understanding of ICH and Health Authority guidelines.
- Proven leader with experience managing highly technical matrix teams and projects.
- Strong interpersonal and communication skills.
- Extensive 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.
- Must have excellent trouble-shooting capabilities.
- Must have experience resolving technical issues.
Job Function: Process Development
Primary Location: NA-US-NJ-Hopewell
: GMS - Biologics Hopewell
Bristol-Myers Squibb - 9 months ago
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