Key deliverables were included management/development of new FDA approved methods for cleaning validations in medical device processing operations.
Worked at various companies such as Boston Scientific St. Jude Medical and Abbott Laboratories. Also spent 18 years at Cargill and another agricultural company specializing in plant startups.
Developed methods for the determination of Drug Release Profiles, Content Uniformity and Assay, and Degradant profiles.
Trained and supervised multiple Chemists in method development/validation.
Determine the required testing for product development.
Resource workload internally and externally as needed.
Lead the highly technical areas in method development to ensure success.
Developed novel HPLC, GC and ICP methods for determination of impurities at the ppb level in polymers and drug products.
Develop novel polymer analysis techniques that enable quantification of polymer impurities down to ppm/ppb levels.