Sr. Group Leader- Analytical Services- Pharma

The role of Senior Group Leader- Analytical Services provides daily operational support for our scientists focused on Stability, ARD and QC work for pharmaceutical and biopharma clients. This includes management and direction of laboratory staff and overseeing lab activities, quality measures, project timelines and execution, and overall compliance in a cGXP/cGMP lab environment. Support for consults, customer and regulatory audits and a focus on process and operational improvements to optimize service and quality is required. Experience with analytical chemistry method development and validation following USP/EP/JP and related compendia is required. A strong working knowledge of analytical method development best practices is also needed, along with an understanding of analytical equipment validation and maintenance activities. Leadership and technical competency are required in this role for method development and validation of small molecule API and drug products including phase-appropriate method development and validation or method transfer to support early-phase clinical development to commercialization. Development of effective and efficient lab processes, including test procedures and lab reports in support of regulatory submissions for marketing approval of pharma products in the US, EU and globally is required for success in this role.

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