Jocelyn X. McQueen

Placeholder Person Graphic
Amgen
Regulatory Affairs Leader Specializing in CMC Strategies
Jocelyn X. McQueen, MS, is a regulatory affairs leader specializing in CMC strategies and submissions within the biopharmaceutical industry, with 15 years of experience spanning drugs, biologics, biosimilars, and combination products. Jocelyn focuses on biological Module 3 strategies and content for global clinical trial applications, marketing applications, and postapproval variations. She has successfully led postapproval variation strategies for drug substance and drug product technology transfers, formulation changes, and analytical method optimizations requiring analytical comparability assessments for monoclonal antibodies and an oncolytic virus, achieving health authority approvals. Jocelyn temporarily focused on site regulatory affairs and supported health authority inspections while working at the Amgen manufacturing site in Singapore. Previously, Jocelyn worked at Supernus Pharmaceuticals as an analytical chemist. Jocelyn holds an MS in bioscience regulatory affairs from Johns Hopkins University.

Related Articles

Considerations for a Decentralized Manufacturing Paradigm
Features
Considerations for a Decentralized Manufacturing Paradigm

The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the...