Chen Ren Email & Phone Number

Lawrence Township, Nj, Us

- Managed and supervised the development and validation of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines.- Reviewed and approved manufacturing batch records, SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, COAs, stability and method validation protocols and reports.- Oversaw all analytical chemistry aspects of manufacturing in CMOs including development and justification of specifications, analysis of release and stability data, OOS & OOT investigation, onsite technical guidance and troubleshooting, CAPAs and Change Controls.- Provided critical, detailed review of external CROs/CMOs test methods, verifications and validations across preclinical and clinical stage programs.- Supported analytical activities associated with the company’s global programs and working closely with internal analytical, CMC, QA, Regulatory, Project Management and Consultants as well as external CROs/CMOs collaborators.- Authored and reviewed Pre-IND/IND, IMPD and annual reports.

- Managed development and implementation of analytical methods at CMOs for release and stability testing for drug substance and drug product.- Oversaw selection of third-party testing laboratories, phase-appropriate method validation, method transfer, testing plans and data interpretation.- Managed global CMOs for manufacturing drug substances and drug products (IV Injectable & Soft Gel Capsules), stability, labeling and packaging activities.- Coordinated filing activities, compiled information and authored the CMC sections for regulatory submission of Pre-IND/IND, IMPD, and Annual Reports.- Monitored and trended in-process, release and stability data for both drug substances and drug products, applying statistical methods of analysis, and guiding project team activities based on stability outcomes.- Established phase-appropriate specifications, proposing shelf life, writing change controls, deviations, review and approval of stability and validation protocols, method of analysis, batch records and reports.- Provided guidance, trouble-shooting problems, investigating OOS and OOT test results and identified key issues that of critical importance for drug development, manufacture and preclinical research.- Oversaw GLP bioanalysis for all the clinical study samples in contract research organizations.- Analyzed data, interpreted results, prepared manuscripts and made presentations internally and at national/international conference.- Played a critical role in the successful technology transfer when changing cGMP manufacturer under aggressive timelines.

- Monitored mass balance and metabolite profiling and identification in healthy human volunteers dosed with radioactively labeled drug product. - Identified the potential metabolites of drug candidates after incubation with liver microsomes by use of HPLC and mass spectrometry. - Successfully managed clinical and nonclinical bioanalysis in various CROs.- Studied the photostability of drug products following ICH (Q1B) guidance and identified the potential degradation products.- Provided review and approval for protocols and reports.- Trouble shooting challenging problems from manufacturing site and improved drug product stability and shelf life significantly.- Worked closely with QA to investigate failed ISR and any other issues in bioanalysis.- Actively involved in CMC activities for analytical method validation, drug substance and drug product stability.

- Set up the bioanalytical laboratory for qualitative and quantitative bioanalysis.- Method development, validation and DMPK analysis of drug candidates using HPLC and LC-MS/MS.- Drug formulation, stability and protein binding studies.- Conducted in vitro metabolism and pharmacokinetic studies for drug discovery and preclinical development of cancer therapeutics.

Columbus, Ohio, Us

Ph.D., Analytical Chemistry

B.S., Applied Chemistry