.jpg "Ken (Zhengkun) Yu, MS photo")
Supervisor, Analytical Development
Thermo Fisher Scientific, Canada
Ken (Zhengkun) Yu, MS, Supervisor (June 2018-present), Analytical Operation, TRO, Thermo Fisher Scientific
• Supervised activities of an Analytical Development Group of 7 scientists. In the past 5 years, all activities of my group have been in accordance with Thermo Fisher SOP, current GMP, ALCOA, corporate quality, project timelines and client expectations. Those activities include analytical method development, evaluation, validation and routine release and stability sample testing in support of about 15 projects. Of 15 products, 2 were approved by FDA, 1 is accepted by FDA for NDA filing review, and 2 are in process of NDA filing.
• Managed monthly revenue to meet departmental revenue target.
• Conducted daily team huddles to facilitate problem solving and communication and ensuring that the lab is well organized and presentable.
• Applied standard procedures and schedule tools to ensure consistent results generation and efficiency improvement.
• Demonstrated good relationships and strong communication skills with internal and external clients, receiving analytical team performance ratings of 10 from 4 clients’ General Performance Survey.
• Stability indicating analytical procedures development and validation for drug substances and drug products with different formulations, such as tablets, capsules, suspension, solution and powder etc.
• Discriminating dissolution method development and validation, including experiment design and data analysis to demonstrate the discriminating ability of the method.
• Method development for cleaning validation and GC methods for residual solvent determination.
• Gap analysis for analytical procedures.
• ICH stability protocol design, including regular stability, photostability, shipment study, open dish and in-use study protocol designs.
• Specification generation and acceptance criteria set up for different phase’s products, including early phase, late phase, registration and commercial products.
• Data interpretation of routine release and stability testing.
• NDA analytical files review.
• Extensive knowledge of GMP regulations, FDA and ICH guidelines.