Job Description - Associate Director, Chemical Characterization Lab
Degree in Analytical Chemistry, Chemical Engineering, Materials Science, or a related technical discipline. Minimum of 12 years of related work experience with a Bachelors degree or minimum of 10 years with a Masters degree or minimum of 8 years with a Ph.D. Significant experience in analytical chemistry or chemical characterization within the medical device industry or related regulated industry. Demonstrated leadership experience in an ISO 17025-accredited laboratory or equivalent regulated environment. Deep technical expertise in chemical characterization methods relevant to ISO 10993-18 (e.g., GCMS, LCMS, ICP-MS, NVR). Strong understanding of FDA and global regulatory expectations for chemical characterization and biological evaluation, Preferred Qualifications: Advanced degree preferred Analytical service lab management within a medical device company. Proven experience leading and developing highly technical teams of at least 15 members. Proven experience managing an operating budget of at least 3.5M Hands-on execution of analytical test methods (e.g., GCMS, LCMS, ICP-MS) Direct experience supporting global regulatory submissions. Experience overseeing external contract laboratories or vendor networks. Participation in industry standards development or regulatory working groups. Demonstrated ability to translate complex analytical data into clear regulatory and business decisions. Strong cross-functional collaboration skills and the ability to influence without authority
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