Michelle Wichert
About Michelle Wichert
Michelle Wichert is the QC Stability Supervisor at Alkermes in Wilmington, Ohio, with extensive experience in pharmaceutical stability programs and quality control compliance.
Company
Michelle Wichert is currently employed at Alkermes as a QC Stability Supervisor. Alkermes is headquartered in Wilmington, Ohio, and Michelle's work arrangement is hybrid.
Title
Michelle Wichert holds the title of QC Stability Supervisor. In this role, she manages pharmaceutical commercial stability programs, oversees site change controls for stability impact, and handles stability-related communications across various project teams.
Education and Expertise
Michelle Wichert studied at Miami University, where she earned a Bachelor of Science degree in Chemistry. She also studied Sociology during her time at the university, spanning from 1993 to 1998. Michelle has developed extensive expertise in quality systems documentation, regulatory compliance, and the management of stability testing laboratories.
Professional Background
Michelle Wichert has a robust professional background in the pharmaceutical and chemical industries. She started her career at Aerotek Scientific as an Analytical Chemist (1996-1998), moved on to Procter & Gamble as a Senior Analytical Chemist (1998-2009), and worked at Kelly Services, Patheon Pharmaceuticals as a Chemist (2011-2012). Michelle spent six years at Forest Pharmaceuticals as a Quality Control Compliance Specialist - Stability (2012-2018) before joining Alkermes.
Achievements
Michelle Wichert has significant experience managing stability programs, adhering to cGMP requirements, and ensuring compliance with USP and FDA guidance. She has successfully handled quality systems documentation, such as change controls, CAPAs, non-conformances, and lab investigations. Michelle is adept at recognizing and managing out-of-specification or out-of-trend data, and she oversees contract laboratories performing ongoing stability testing.