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.
• 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.
• 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..
• 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.
• Commercial Activity Management- Commercial reference standard management, reference standard qualification, re-qualification, ensure the consistent and continuous supply of reference standards - Coordinate response to.

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.
• 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.
• 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.
• 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