Jason Qian

Direct a team in the development, optimization, and validation of analytical methods for starting materials, intermediates, and APIs. Host and manage FDA, NMPA, and client audits, ensuring compliance with cGMP standards. Review and approve GMP documentation, including SOPs, method validation reports, and CAPA investigations. Oversee method transfers, writing protocols and reports to ensure smooth transitions between labs. Train scientific staff, guiding them in critical decision-making and aligning their efforts with departmental goals. Contribute to company management by driving strategic scientific initiatives and fostering a transparent, quality-focused work environment.

Review and edit submissions for Journal MOJ Bioequivalence & Bioavailability

Project Leader: Develop and validate analytical test methods for Oligonucleotide products (Targeted RNAi Molecules). Coordinate analytical tests related to in-process control, GLP and GMP batch release and stability program. Represent Analytical development group to report project progress to manufacturing, client and upper management team. Conduct trend analysis and out of specification investigations.

Method development and validation

Leading analyst for contract manufacturing project. In charge of raw material release, in process control, intermediate release and API testing

Validated analytical method development- monosaccharides/oligosaccharides, vitamins, minerals, organic acids, Fatty acids, mono-, di-, tri-glycerides, lactates, polyphenols, impurities/odd flavors by GC/MS headspace, solid-phase-micro-extraction(SPME) Instrumental analysis- HPLC(RP, Ion-exchanging, size-exclusion; VWD, PDA, EC, CAD), GC (FID, MS, Headspace, SPME), UV-vis, FTIR, water activity, rancidity, viscosity, falling number, and any miscellaneous bench top chemical/physical measurements. Responsibility covers installation, qualification, application, maintenance and troubleshooting. Standard Operation Procedure composition for all analytical service methods. Technical support for internal(raw material procurement, product development and innovation) and external customers, as well as company’s manufacturing issues. Training junior scientists/technologists.

Analytical method development and validation: nutritional ingredients; Outsourcing analysis management; Documentation: SOPs, production protocols, test methods and specifications; Formulation: new nutritional ingredients and products; Management: QA/QC lab with 8 reports, inventories of reagents, supplies, samples and instruments. Regulatory inspections: Training and FDA onsite;