Jun Zhang

Background

About Jun Zhang

Analytical Manager supporting drug and consumer health new products development and commercialization. Overall experience and responsibilities are summarized below: • Extensive leadership in Analytical R&D supporting new drug and consumer health products development and commercialization. CMC module 3 documentation preparation and review for NDA submission. APR (Authorization for Product Release) documentation review and approval for consumer health product launches. • Managed analytical method development, validation, transfer to manufacturing facilities. Managed analytical support for formulation development, GLP/GMP products release, stability testing, product specifications, laboratory investigations, audits and inspections, change control, and marketed product investigations. • Played a key role in the development of Lastacaft Ophthalmic Solution resulting in the successful IND and NDA filing and approval. Led J&J Consumer Health major Corrective and Preventive Actions (CAPA) projects for the implementation of impurities testing and USP Topical and Transdermal Product Quality Tests for 250+ marketed OTC drug products. • Broad Knowledge of GLP, cGMP, USP/EP, ICH, and FDA regulatory guidelines. Reviewer of newly proposed industrial standards such as ICH guidance and USP general chapters and monographs. Owner and Subject Matter Expert (SME) of various J&J Consumer Health key Standard Operating Procedures (SOPs). • Extensive experience in working with a wide variety of dosage forms, including solid, semi-solids, liquids, suspensions, etc. In-depth knowledge and experience in various analytical techniques including HPLC/UPLC, GC, UV-Vis, FT-IR, GC-MS, ICP-MS, Raman, dissolution, viscosity, and wet chemistry, etc. Strong chemistry foundation, method development and trouble shooting skills. • Extensive collaboration and communication with cross functional teams. Leadership in global analytical initiatives driving procedure simplification and harmonization. Responsible for development plans, goals, objectives and performance reviews of direct reports.