OBJECTIVE:

Seeking a challenging senior analytical chemistry position in an organization that fosters intellectual growth and provides an opportunity for career advancement based on performance.

SUMMARY:

• Experienced in managing analytical research and development, and quality control laboratories that include stability, finished products (API, Solid, Semisolid, liquid, and suspension dosages), raw material, and microbiology testing laboratories.
• Experienced in analytical method development and validation of the drugs, API (Active Pharmaceutical Ingredients), prescription (solid, semisolid, liquid, and suspension), OTC, and controlled drugs, validation of stability indicating method, solution stability studies. Experienced in cleaning validation of the drug residue and the detergents.
• Extensive experience in cGMP/GLP and DEA regulations, USP/NF methods of analyses, FDA and ICH guidelines and broad understanding of quality control principles. Also experienced in analytical methodologies of JP, BP, and EP; and IQ, OQ and PQ of the instruments.
• Experienced in overseeing the laboratory operations including investigations, deviations, method development, validation, method transfer and troubleshooting, reviewing the SOP, and CMC submissions. Also experienced in handling of several projects.
• Experienced in interaction with the FDA and responding to the FDA 483 citation and FDA deficiency letter for the product.
• Experienced in operation and maintenance of HPLC, GC, UV - vis, Dissolution Instrument, Flame Photometer, FT-IR, Karl Fischer, Near-IR, TGA, PXRD, GC-MS and LC-MS.
• Experienced in computer, like Lotus, Microsoft word, Excel and Power point.
• Proven records of initiative and achievement-numerous methods and published several papers in the international journals resulted from research works.

PROFESSIONAL EXPERIENCE:

Confidential, Saint Louis, MS

Director

• Managing the operations of Finished product, Raw materials, Stability and Microbiology
• Responsible for Method development and Validations, Method Verification, Method transfer of Drug substances and drug products.
• Responsible for releasing raw materials, in-process testing, finished product testing
• Responsible to communicate with customers for the progress of the project
• Responsible to do the troubleshooting of the Analytical instruments, like HPLC, GC, GC-MS, UV-vis, FT-IR, Karl Fischer, etc
• Experienced in collaborations with big pharma companies and organizations
• Responsible to organize meetings for verities of projects for both domestic and international customers,

Confidential, Wisconsin

Director of Confidential and Analytical R&D

• Managed the operations of Confidential and Analytical R&D.
• Responsible for Process Development, Method development and Validations, Method transfer of API products
• Responsible for releasing raw materials, in-process testing, finished product testing
• Experienced in Flavor Chemical analysis and Stability Testing
• Experienced in cGMP regulations, ICH, USP, BP, EP and JP guidelines
• Experienced in interacting with the CMO, FDA, outside auditors of both domestic and internationally
• Experienced in auditing the outside vendors and the Laboratory
• Experienced in OOS investigations
• Experienced in Handling of GC, GC-MS, HPLC, LC-MS, KF, FT-IR, UV vis etc
• Experienced in collaborations with big pharma companies and organizations, like Pfizer, Abbott, some international companies and Argonne National Laboratories.
• Experienced in writing the protocol and the report

Confidential, Romeoville, IL

Manager

• Responsible for reviewing and approving the batch of the FDA products of Cow Hygiene products, like, different types of Teat Dips, non-Iodine Teat Dips, Udderwash, CIP detergents, monitoring the stability data, in-process testing, raw materials, determination of the specifications of the products and the raw materials.
• Responsible for Analytical Method Development and Validations of all new formulation products of Cow Hygiene Products.  
• Interacted with FDA when FDA audited the company.
• Responsible for IQ, OQ and PQ of the instruments, the PM (preventive Maintenance of the instrument) and the calibrations of the instruments.
• Responsible to contact with the outside laboratory service and buying the new equipment and chemicals.

Confidential, Chicago, Illinois   

Senior Manager

• Responsible for reviewing and approving all the analytical results of the stability raw materials, in process and finished products, API( Active Pharmaceutical Ingredients).
• Responsible for the development and validation of new methods for the analyses of pharmaceutical products including the determination of the impurities by HPLC, GC and GC-MS.
• Responsible for the calibrations, PM (preventive maintenance), PVP (Performance Verification procedure) and IQ/OQ/PQ of the laboratory instruments.
• Responsible to contact outside laboratories for outside laboratory tests and vendors for buying equipment, chemicals, and supplies.
• Responsible to lead the investigations of OOS (Out of Specification) results and write the investigation reports of OOS.

Director

Confidential

• Managed the operations of the QC laboratory dealing with the release testing of commercial API production batches, tablets and capsules, stability and raw material testing. Supervised several basic and advanced chemists. Responsible for reviewing and approving production batch records.
• Approved and released several raw materials and intermediate products for the production of API and the formulation products, like tablets and capsules.
• Developed, validated, and transferred HPLC methods for API, Intermediate Products and cleaning validation. Experienced in process validation.
• Experienced in writing the Out of Specification (OOS) report and led several investigations of OOS.

Confidential, Gurnee, Illinois

Manager

• Supervised and managed Quality Control, Stability Department, Microbiology, Research, and Development Analytical Laboratories. Upgraded company s SOPs.
• Responsible for method development and validation of new methods for the analyses of new
• drugs, in - process product, finished product, stability study, SOP writing, calibration of
• Dissolution instruments, reviewing and approving the production batch records.
• Succeeded in the investigations of several OOS (out of specifications) results.
• Developed and wrote analytical cleaning procedure for pharmaceutical manufacturing equipment.
• Succeeded in failure investigation of Dissolution Procedure for the analyses of Digoxin, and developed an improved method for Digoxin analysis, and presented the improved method results to FDA.
• Interacted with the FDA and addressed all of the FDA s questions during inspection.