Experience

Celcuity

• United States
• Biotechnology
• 1 - 100 Employee

• Executive Director of Pharmaceutical Development

  • Nov 2021 - Present



G1 Therapeutics, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director of Pharmaceutical Development

  • Jul 2018 - Present

  • Lead an intravenous injectable drug product manufacturing by working with a CMO to support late phase clinical trials and registration batches’ stability study. • Lyophilization cycle critical parameters robustness study. • Design and lead various studies of the drug product at CROs to support potential NDA submission including XRPD determinations, in-use stability and compatibility study, in-use microbial challenging study, stopper extractable and leachable study and etc. • Prepare for commercial launch by leading drug product manufacturing, packaging and labeling. • Work with internal regulatory affair in writing submission documents for IND, IMPD, and potential NDA and MAA. • Monitor project timeline and budgets. Show less



Cempra Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Chemist, Director, Senior Director, Executive Director of Drug Product Development

  • Dec 2010 - Jul 2018

  ● Manage CROs and CMOs in drug product development, analytical development, tech transfer, manufacturing and testing to meet the company’s fast timeline for phase I to phase III clinical trials, NDA submission and potential commercial launch (preparation for process validation, commercial product labeling and packaging). ● Write regulatory submission documents for US, Canada and EU submissions including IND, IMPD, NDA and MAA. ● Involved in budget planning for product development, tech transfer, manufacturing and testing. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Principal Scientist

  • Jun 2009 - Sep 2010

  Functioned as a group leader for the drug product process development, its adjuvant product formulation and manufacturing process development of an Alzheimer’s disease vaccine at phase II/III stage. ● Developed the manufacturing process of the vaccine drug product and its adjuvant product at phase III/commercial scale. Participated in the drug product and adjuvant product clinical supply manufacturing. ● Participated in project meetings including representatives of drug substance, drug product, analytical and regulatory team members. ● Developed a phase III formulation of the adjuvant product to improve the stability and therefore to extend the shelf life. ● Participated in the phase III/commercial manufacturing site selection and the technical transfer of the manufacturing process to the manufacturing site. . Show less



Eisai US

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist I and II

  • Jan 2002 - May 2009

  Functioned as a group leader in developing injectable drug products’ formulation and manufacturing process of two anticancer compounds. Transferred drug product manufacturing process to the clinical supply manufacturing facilities. Licensed enabling technology to improve drug developabilities. ● With the highly potent cytotoxic compound, performed pH–solubility and stability studies with very limited amount of drug substance. Developed a buffered aqueous formulation and a back-up freeze-dried formulation. Followed the project from IND filing until NDA filing. Took major responsibilities in writing drug product sections of IND, IMPD, NDA and MAA. ● With the compound of low water solubility and poor chemical stability, performed a comprehensive evaluation on various solubilization approaches to achieve sufficient solubility for preclinical studies. Took leadership in licensing in Captisol (SBE-7-Cyclodextrin) technology to develop a phase I/II freeze-dried formulation to overcome the solubility issue. Took the leadership in writing the CMC sections for IND filing. ● Performed compatibility studies between drug products and injection/infusion devices to support clinical trials. Performed compatibility studies between drug products and manufacturing equipment to support CTM manufacturing. Reviewed CTM manufacturing batch record and participated in CTM manufacturing. Show less



Quintiles Corp

• Kasas City, MO

• Senior Associate Scientist

  • Sep 2000 - Dec 2001

  • Performed physical chemical characterizations of drug substances, including pH-solubility, pH-stability, intrinsic dissolution and drug excipient compatibility study. Instrumentation of HPLC, UV-Vis absorption, differential scanning calorimetry (DSC) and micro-watt calorimetry were used. • Developed and validated a DSC method for measuring the content of a polymorphic form of API in the bulk API material. • Performed physical chemical characterizations of drug substances, including pH-solubility, pH-stability, intrinsic dissolution and drug excipient compatibility study. Instrumentation of HPLC, UV-Vis absorption, differential scanning calorimetry (DSC) and micro-watt calorimetry were used. • Developed and validated a DSC method for measuring the content of a polymorphic form of API in the bulk API material.



Oread Inc

• Lawrence, KS

• Scientist III

  • Oct 1998 - Aug 2000

  • Performed salt screening and polymorphism screening projects to select a suitable API salt form for solid dosage development. The various salt and polymorphic forms were characterized by cross-polarized microscopy, DSC, TGA, PXRD, DVS and NMR. • Performed physical characterizations of the pre-lyophilization solutions and the lyophilized products using DSC. • Performed salt screening and polymorphism screening projects to select a suitable API salt form for solid dosage development. The various salt and polymorphic forms were characterized by cross-polarized microscopy, DSC, TGA, PXRD, DVS and NMR. • Performed physical characterizations of the pre-lyophilization solutions and the lyophilized products using DSC.



The University of Kansas

• United States
• Higher Education
• 700 & Above Employee

• Postdoctoral Research Fellow, Department of Pharmaceutical Chemistry

  • Aug 1997 - Sep 1998

  • Developed injectable formulations of various anticancer drugs to support preclinical studies. The type of drug candidates included peptide boronic acid derivatives, phenylurea thiocarbamate and camptothecin analogs. • Determined degradation pathways and mechanisms using HPLC, NMR and Mass Spectroscopy. • Developed HPLC methods for the anticancer compounds. • Developed injectable formulations of various anticancer drugs to support preclinical studies. The type of drug candidates included peptide boronic acid derivatives, phenylurea thiocarbamate and camptothecin analogs. • Determined degradation pathways and mechanisms using HPLC, NMR and Mass Spectroscopy. • Developed HPLC methods for the anticancer compounds.