Yongmei Wang
About
Yongmei Wang is from Greater Boston. Yongmei works in the following industries: "Biotechnology Research". Yongmei is currently Associate Director, CMC Quality and Compliance (mRNA platform) at RVAC Medicines, located in United States. In Yongmei's previous role as a Molecule Steward, Principal (CMC Development) at Sanofi Genzyme, Yongmei worked in Framingham, MA until Nov 2021. Prior to joining Sanofi Genzyme, Yongmei was a CLO Quality Oversight at Bioverativ, a Sanofi company and held the position of CLO Quality Oversight at Waltham, Massachusetts. Prior to that, Yongmei was a Manager, QC Validation at Sanofi Genzyme, based in Greater Boston Area from Oct 2013 to Jun 2018. Yongmei started working as Analytical Development Scientist at Lonza in Nov 2011. From Feb 2005 to Oct 2011, Yongmei was Associate Scientist - Analytical Development at Stryker Biotech.
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Yongmei Wang's current jobs
Yongmei Wang's past jobs
Played key role in development of analytical control strategy and process control strategy; led specification development; authored and reviewed CTD module 3 sections for major post-marketing process changes resulted in FDA and EMA approvals. Collaborated with cross-functional team including supply chain, development, technology transfer, process validation and commercial manufacturing to ensure a holistic control of product quality. Responsible for product knowledge management through product lifecycle.
Established business contracts and quality agreements with multiple Contract Laboratory Organizations (CLO) within a relative short time to enable a successful business transition. Managed CLO relationship and oversaw CLO activities including method development, method transfers, shipping of materials and retention sample storage. Participated in CLO selection, budgeting and audit.
Performed and supervised analytical method validation and transfer activities; responsible for the analytical lifecycle management; authored regulatory submission and response; supported specification development; conducted investigation/root cause analysis for deviation/OOS.
Method transfer; Comparability evaluation and qualification of analytical methods; Support upstream and downstream process development and protein characterization; deviation investigation, root cause analysis and impact assessment
Developed and qualified analytical methods including HPLC, ELISA, CE and Weston Blot; performed comprehensive characterization of human recombinant protein products to support process comparability and IND filing; worked closely with the purification process and formulation process; wrote technical reports in support of regulatory submission.