Yuming Chen Email & Phone Number

Lawrence Township, Nj, Us

• Chair of Commercial Specification Committee (Small Molecules)- Provide guidance to multi-functional group for Commercial Specification change proposal and justifications- Lead Commercial Specification Committee for endorsement of commercial specification (PPQ and after) establishment and updates- Justification of Specification review and approval- Specification related Initiatives • Strategic Analytical Lead of Small Molecule Commercial Products- Highly matrixed working environments, project driven through coordinating work among analytical development, regulatory CMC, multiple QA functions, different manufacturing and QC sites, country specific teams - Oversight analytical strategies for over 20 late stage and commercial small molecule products: commercial project analytical strategy, project management, risk assessment -Support life cycle regulatory filings: support rest of world filings, prior approval submissions, follow-up measures, post-approval commitments and post approval changes• Organizational Integration- Lead and participate integration of multiple functions into new organization structure- Establish and maintain stakeholder relationships

Summit, New Jersey, Us

• Manger of Analytical Support for Commercial Projects- Cooperate with VQM, internal and external QA and analytical team, to provide analytical support for 9 commercial products, including both API and drug products. - Oversight method transfer/validation, OOS/OOT/OOE investigation in CSPs (contract service provider); remote trouble shooting; direct and approve investigation protocols and reports; ensure timely closure of deviations- Support HA inspections; support regulatory CMC for global filing, responded to Health authority questions worldwide, such as Russian, China, Uruguay, etc. • Analytical Lead of Late Stage Project with NDA Filing- Communicate and coordinate analytical activities among different sites, including manufacturing drug substance sites, drug product sites, stability testing sites, and research sites- Identify analytical gap with filing risk and inspection risk; develop remedy strategies and implement them - Develope specifications for starting material, intermediates, API based on process capability, historical data; develope control strategy for API- Mock PAI support for drug substance and drug product sites - NDA review, strategy suggestions, generate reports to support filing claims• Commercial Activity Management- Commercial reference standard management, reference standard qualification, re-qualification, ensure the consistent and continuous supply of reference standards - Coordinate response to U.S. and European Pharmacopoeia requests on monograph generation and information collection with legal directions; oversight Pharmacopeia update evaluation and review - Complaint samples and counterfeit samples

North Chicago, Illinois, Us

• Analytical Function Lead for multiple projects in cross-functional teams to ensure API development and delivery• Control strategy development, acceptance criteria development, GTI assessment, reviewing document including IND documents, Request for Purchasing, SOPs, reports, direction sets, etc. • Providing analytical expertise and support by developing analytical methods to track impurities and determine metals, residual solvents, moisture, loss on drying, salt content, potency, purity and ID of starting materials, intermediates and the active pharmaceutical ingredient (API) • Waters LC/MS Core Team Leader, promoting usage of Waters instruments, providing LC/MS consultant and training to department membrane, evaluating LC/MS technologies, planning and suggesting future LC/MS purchasing

• Analytical laboratory set up : start analytical R&D laboratories for DPI product by providing key input on laboratory design and planning, utility requirements; purchasing of all types of analytical instruments, chemicals, and consumables for continuous operation. • Directed R&D analytical group and project related analytical activities to support formulation development of DPI products, including new employee training, method development and validation, analytical support for formulation, setting final product specifications, informal stability study design, drafting/reviewing/approving of SOPs, and implementation of LIMS system.• Built a high efficiency of analytical team from selectively screening of candidates to directing career development of team members.

Us

• As mass spectrometry specialist to provide analytical support for drug development across the analytical department; expertise on mass spectrometer systems from ABSciex, Thermal, Waters, and Agilent • Quantitative LC/MSn and GC/MS method development, validation, and transfer for trace amount of impurities; GMP sample analysis using LC/MS/MS and GC/MS • Unknown impurities structure elucidation by mass spectrometry; impurity profiling by forced degradation study• New instruments evaluation and purchasing• Evaluation and oversaw contract lab for method development, transfer, validation, and GMP sample analysis

Fridley, Minnesota, Us

• Method development, validation, transfer for drug substance and drug product analysis by HPLC and UPLC• NIR test for blend uniformity and content uniformity• Evaluated, introduced, and purchased new instruments to meet the emerging analytical challenge• Prepared and reviewed reports/SOPs• Four weeks of full time intensive training on Six-sigma for Black Belt for pharmaceutical development• Technical presentations on conferences, to R&D personnel

Post Doctor

Ph.D, Analytical Chemistry

Education record

Education record