SOMANATH DEV PH.D. US CITIZEN

Buffalo Grove, IL *0089,

Tel no. 847-***-**** (Cell), E-mail: adbxi1@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Twenty-two years’ experience in managing Quality Control Laboratory, Analytical R&D Laboratory, raw material, stability and microbiology testing (USP <85>, Endotoxin, USP <71>, Sterility testing, Microbial count USP <61>), and Environmental Monitoring.

Worked on drug substance (API), drug products like Solid (Tablet, Capsule and Soft Gel), Semisolid (Ointment and Cream), liquid, suspension, Nasal Spray and different types of parenteral sterile Injectable dosage products including the Controlled drugs (Schedule II to V) and Biological products, like Protein, Cholesterol, Amino acid, and peptide.

Experienced in analytical method development and validation of the drugs substances, API (Active Pharmaceutical Ingredients), prescription (solid, semisolid, liquid, and suspension), OTC, and controlled drugs, validation of stability indicating method, solution stability studies and also cleaning validation of the drug residue and the detergents.

Skilled in writing the validation and method transfer protocols, reviewing the test results, validation report, OOS, OOT, Root Cause Analysis, Change Control. LIR investigation reports. Trend Analysis of all the Analytical Data and the Annual Product Report.

Extensive experienced in cGMP/c, GLP, cGDP, OSHA, EPA and DEA regulations, 503B Compounding pharmacy regulations, USP/NF methods of analyses, FDA and ICH guidelines and broad understanding of quality control principles. Also experienced in analytical methodologies of USP; JP, BP, and EP; and IQ, OQ and PQ of the instruments and the preventive maintenance of the instruments.

Experienced in overseeing the laboratory operations including OOS, OOT investigations, NCR, LIR, CAPA, deviations, method development, validation, method transfer and troubleshooting, reviewing the SOP, and CMC submissions. Also experienced in handling of multiple projects simultaneously.

Interacted with the FDA, Quality Assurance, Regulatory, Quality, and responded to FDA 483 Warning letters and FDA deficiency letters to get approval of ANDA submission.

Worked with Regulatory, Quality, Quality Assurance and the Production groups.

Experienced in operation and troubleshooting of HPLC, UPLC, GC, UV-vis, Dissolution Instrument, Flame Photometer, FT-IR, Karl Fischer, Near-IR, TGA, PXRD, GC-MS and LC-MS.

Skilled in computer, like Lotus, Microsoft Outlook, Minitab, Microsoft word, Excel, Oracle, Track wise and Power point.

Proven records of initiative and achievement-numerous methods and published several papers in the international journals resulted from research works.

Experienced in conducting performance appraisals, recommendation of salary increase, coaching employees, and team building. Supervised BS, MS, and Ph.D. level chemists.

PROFESSIONAL EXPERIENCES

PharMEDium LLC (a division of AmerisourceBergen), Cleveland, MS (11/ 2018 – current), Manufacturer of Sterile Injection products of Controller drugs and non-Controlled drugs. Site Head of Quality Control Laboratory

Due to lacking of room for expansion and business decision, this site will be closing within a few months.

Oversee daily activities of the three shifts to support the sterile manufacture of Controlled drugs and non-controlled drugs.

Investigate the OOS (Out of Specification), OOT (Out of Trend), CAPA,

(Corrective action and Preventive Action), NCR, Method Deviation, and Change Control.

Review and approve the Analytical data. Also responsible to evaluate and interpret the test results.

Extensive experience in cGMP, cGLP, cGDP, FDA regulations, ICH guide lines, and USP/NF, BP, EP and JP methods of analyses.

Evaluate the Analytical development and validation report.

Write the Study plan protocol for the new analytical method transfer

Review and approve the specification of finished products and raw materials.

EMD Millipore Corporation, Kankakee, Illinois, Biological products manufacturer

Head of Quality Control Laboratory and Microbiology Laboratory 10/2017-9/2018

Due to down size of the company revenue for first, second and third quarter, 2018, several positions were eliminated.

Managed the Quality Control, Stability, Microbiology, and Analytical R&D Laboratories.

Oversaw the daily activities to support the manufacture of regulated and non regulated

Products.

Investigated the OOS (Out of Specification), OOT (Out of Trend), Root Cause Analysis and the CAPA (Corrective action and Preventive Action).

Reviewed and approved the Analytical data. Also responsible to evaluate and interpret the test results.

Extensive experience in cGMP, cGLP, cGDP, FDA regulations, ICH guide lines, and USP/NF methods of analysis.

Developed and validated Analytical methods.

Hands on experience in handling and troubleshooting of HPLC, GC, Karl Fisher, UV vis. etc.

Responsible for raw material, in-process product, finished product, and stability studies.

Responsible for the specification of finished products, in process and raw materials.

Pharma-Tech Industries, Union, Missouri

Head of Quality Control Laboratory and Microbiology Laboratory 1/2017-10/2017

Resigned due to very high Health Insurance cost.

Supervised and managed Quality Control, Stability, Microbiology, Research, and Development Analytical Laboratories.

Responsible for method development and validation of drug substances and Drug products

Responsible for Method Optimization, Method Improvement, and Method Transfer

Responsible for raw material, in-process product, finished product, stability study, SOP writing,

Responsible for the investigations of OOS (out of specifications) results, LIR, Root cause analysis

Responsible for the specification of raw materials, in process and finished products.

Contract position 2/2015-09/2016

Director of Quality Control Laboratory, Analytical R&D and Microbiology

Alkem Laboratories Ltd, and Apiscent Laboratory

Manufacturer of Tablet, Capsule, semisolid, liquid, suspension products and different types of Drug substances (API).

Managed the operations of Finished product, Raw materials, Stability and Microbiology

Led the Method development and Validations, Method Verification, Method transfer of drug substances and drug products.

Released raw materials, in-process testing, and finished product testing

Experienced in communicating with the customers for the progress of the project

Skilled in troubleshooting of the Analytical instruments, like HPLC, GC, GC-MS, UV-vis, FT-IR, Karl Fischer, etc

Experienced in interacting with the FDA, responding to the FDA 483 and FDA deficiency letters to get approval for ANDA submission.

Worked together with Regulatory, Quality Assurance, Quality and Production group

Experienced in collaborations with big pharma companies and organizations

Organized meetings for verities of projects for both domestic and international customers.

Established and allocated the Budget for the Laboratory

Skilled in Flavor Chemical analysis and Stability Testing

Experienced in cGMP, cGLP and cGDP regulations, ICH, USP, BP, EP and JP methods of analyses

Worked as SME (Subject Matter Expert) when FDA inspected the Laboratory

Audited the outside vendors and the Laboratory

Led several OOS investigations, LIR, CAPA, Root Cause Analysis and Method Deviation

Worked in collaborations with big pharma companies and organizations, like Pfizer, Abbott, some international companies and Argonne National Laboratories.

GEA Technology Inc. German based company, Romeoville, IL

Manager, Quality Control and Analytical R&D Laboratory 8/2013-12/2014

Resigned and decided not to go to German permanently

Reviewed and approved the batch of the FDA products of veterinary products, like, different types of Teat Dips, non-Iodine Teat Dips, CIP detergents, monitoring the stability data, in-process testing, raw materials, determination of the specifications of the products and the raw materials.

Skilled in Analytical Method Development and Validations of all new formulation products of veterinary Products.

Interacted with the FDA when FDA audited the company.

Worked together with Regulatory and Quality Assurance groups

Responsible for IQ, OQ and PQ of the instruments, the PM (preventive Maintenance of the instrument) and the calibration of the instruments.

Contacted with the outside laboratory service and buying the new equipment and chemicals.

Narchem Pharmaceuticals, a contract pharmaceutical manufacturing company,

Chicago, Illinois 8/2003- 8/ 2013

Senior Manager, Quality Control and Analytical R&D, got a better opportunity

Reviewed and approved all the analytical results of the stability, raw-materials, in- process and finished products, API (Active Pharmaceutical Ingredients).

Developed and validated several 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.

Contacted outside laboratories for outside laboratory tests and vendors for buying equipment, chemicals, and supplies.

Worked as SME (Subject Matter Expert) when FDA inspected the Laboratory, responded to FDA 483 and FDA deficiency letter.

led the investigations of OOS (Out of Specification) results and wrote the investigation reports of OOS.

Worked in collaborations with big pharma companies and organizations, like Pfizer, Abbott, some international companies and Argonne National Laboratories.

Houba Pharmaceutical Laboratories, Inc. (A subsidiary of Halsey Drug, NY), Indiana 4/1999-8/2003

Director, Quality Control and Analytical Research and Development Laboratories,

closed in 2003 permanently

Managed the operations of QC laboratory dealing with the release testing of commercial API production batches, tablets and capsules, stability and raw material testing.

Reviewed and approved the production batch records of the finished product, In- process testing, raw releasing and, intermediate products of API.

Experienced in writing the Out of Specification (OOS) report and led several OOS investigations

Interacted with the FDA, responded to the FDA 483 and FDA deficiency letter

Worked together with Regulatory, Quality Assurance, Quality and the Production groups

Worked as a SME (Subject Matter Expert) when FDA inspected the Laboratory.

Managed the operations of Analytical R&D Laboratory and handled several projects of controlled drug substances, like Butalbital, Codeine, Codeinone, Hydrocodone and Morphine.

Led the Development and Validation of Analytical methods for the new product testing and new methods. Experienced in validation of Stability indicating Method. Developed a new method for the analysis of several Controlled drug substances, which resulted in additional funding from an investor.

Established specifications for the API of the controlled substances, Qualification of impurity standard by characterizing the impurities by LC-MS, APCI mass, NMR, IR, and HPLC.

Experienced in determining the specifications for the Impurity standard, test procedures and other Laboratory controls required by cGMP and cGLP. Wrote the Test Methods and SOPs.

Responsible for providing analytical support to Research and Development Laboratory and production unit. Routine analysis of in-process and finished products, and stability study.

Alra Pharmaceutical Laboratories, Inc. Gurnee, Illinois, 2/1997-8/1999

Manager, Quality Control Laboratory and Research and Development Analytical

Laboratory. Resigned, got a better opportunity

• Supervised and managed Quality Control, Stability, Microbiology, Analytical R and D Laboratories. Upgraded company’s SOPs.

• Developed and validated 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 validated analytical cleaning procedure for the drug substances and the detergents.

• 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.

Worked as SME (Subject Matter Expert) when FDA inspected the Laboratory,

Responded to the FDA 483 and FDA deficiency letter

Worked together with Regulatory, Quality Assurance, Regulatory and the Production.

EDUCATION

University of Kentucky, Lexington, Kentucky,

Post Doctoral Research Scholar, Department of Chemistry

University of Illinois, Urbana-Champaign, Illinois

Postdoctoral Research Fellow, Department of Chemistry

Ph.D., Chemistry, University of Tokyo, Tokyo, Japan,

Advanced Post Graduate Course, Chemistry, Tokyo Institute of Technology, Japan,

TRAINING

Attended training on Test Method validation, Validation process, Quality System, Root Cause Analysis, conducting performance appraisals, Out of Specification Results, cGMP/GLP organized by FDA in Indiana, HPLC troubleshooting training organized by Water and Hewlett Packard.

HONORS C. Chem. MRSC (Chartered Chemist, Member, Royal Society of Chemistry), U.K.

SCHOLARSHIPS

1. German Govt. DAAD Scholarship and Japan Govt. Education Scholarship

2.UNESCO Advanced Post-Graduate Research Fellowship

3.US Govt. DOE (Department of Energy) fellowships two times

PUBLICATION

Published a few papers in USA, German, UK, Japan and France.

References of Publications available upon request.

PRESENTATION

Presented a few papers in national and international conferences of American Chemical Society in USA and the International Conference of Japan Chemical Society, Tokyo, Japan.

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