Quality Control manager/ director

SOMANATH DEV PH.D.

Buffalo Grove, IL *****,

Cell: 847-***-****, E-mail: *********@*****.***

https://www.linkedin.com/in/somanath-dev-ph-d-a453489/

OBJECTIVE

Looking for a challenging Quality Control Management position in an organization that fosters intellectual growth and provides an opportunity for career advancement based on performance

SUMMARY OF QUALIFICATIONS

Proven track record directing the Quality Control Laboratory, Analytical R&D Laboratory, raw material, stability, and microbiology testing (USP <85>, Endotoxin, USP <71>, Sterility testing, Total Microbial count USP <61>, <62>, and Environmental Monitoring. Also led 503B Compounding pharmacy laboratory dealing with varieties of Sterile injectable controlled drugs of schedule II to V. Extensive experience in CDMO and CMO.

Worked on drug substances (API), varieties of raw materials, drug products like Solid (Tablet, Capsule, and Soft Gel), Dietary Supplement, Semi-solid (Ointment and Cream), liquid, suspension, Nasal Spray, and different types of parenteral sterile Injectable dosage products and biological products, like Protein, Cholesterol, Amino acid, and peptides.

Extensive experience in cGMP, cGLP, cGDP, OSHA, EPA, and DEA regulations, 503A & 503B Compounding pharmacy regulations including Aseptic Testing, USP <795>, USP <797> pharmaceutical compounding 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, EP; and IQ, OQ, and PQ of the instruments and the preventive maintenance of the instruments.

Extensive experience in the certification, regulations and compliance of 17025.

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

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

Extensive experience in Interacting with the FDA, Quality Assurance, Regulatory, Quality, customers, and vendors, and responded to FDA 483

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

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

PROFESSIONAL EXPERIENCES

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

03/22-present

Tedor Pharmaceuticals, Providence, Rhode Island

Supervising and managing Quality Control, Stability, Analytical R&D, Micro laboratory, and Development Analytical Laboratories.

Reviewing and approving the specification of finished products and raw materials

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

Investigating the OOS (Out of Specification), OOT (Out of Trend), CAPA and the deviation

Releasing raw materials, API, in-process testing, and finished product testing

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

Reviewing the Microbiology results of both Finished products, USP purified water and the raw materials.

Responsible for APR (Annual Product Review), Trend Analysis of Stability Studies, Raw Materials, OOS and OOT.

Laboratory Director (Chemistry and Microbiology) 4/2020-03/2022

Wells Pharma of Houston, Houston, Texas

Supervising and managing Quality Control, Stability, Microbiology, Research, and Development Analytical Laboratories.

Responsible for Method Optimization, Method Improvement, and Method Transfer

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

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

Write the Study plan protocol for the new analytical method transfer.

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

Write the Study plan protocol for the new analytical method transfer.

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

Site Head of the Quality Control Laboratory 01/2018 – 12/2019

PharMEDium LLC (a division of AmerisourceBergen),Cleveland, Mississippi

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 for evaluating and interpreting the test results.

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

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.

Head of Quality Control Laboratory & Microbiology Laboratory

10/2017- 9/2018

EMD Millipore Corporation, Kankakee, Illinois, Biological products.

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

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

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 for evaluating and interpret the test results.

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

Developed and validated Analytical methods.

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

Responsible for raw materials, in-process products, finished products, and stability studies.

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

Head of Quality Control Laboratory and Microbiology Laboratory

1/2017-10/2017

Pharma-Tech Industries, Saint Louis, Missouri.

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.

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

2/2015-09/20 16

Alkem Laboratories Ltd. Saint Louis, Missouri

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

Led the Method development and Validations, Compendial Method Verification, and 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 projects

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

Experienced 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 varieties 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 an 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.

Earlier Career ( 1999-2013)

•Director-level roles at Narchem Pharmaceuticals, GEA Technology Inc., and Houba Pharmaceutical Laboratories

•Progressive responsibility for QC, Analytical R&D, stability, and raw material testing

•Key accomplishments: Developed controlled substance methods that secured additional investor funding; served as FDA SME across multiple inspection

EDUCATION

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

Postdoctoral Research:

•University of Kentucky, Department of Chemistry

•University of Illinois at Urbana-Champaign, Department of Chemistry

Advanced Post Graduate Studies: Tokyo Institute of Technology, Japan

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

SCHOLARSHIPS & Fellowships

•U.S. Department of Energy Fellowship (awarded twice)

•German Government DAAD Scholarship

•UNESCO Advanced Post-Graduate Research Fellowship

•Japanese Government Monbusho Scholarship (Ph.D. program)

PUBLICATIONS

1) S. Dev, E. Ramli, T.B. Rauchfuss and S.R. Wilson, J. Am. Chem. Soc. 112, 112, 1990, 6385.

2) S. Dev and J.P. Selegue, J. of Organometallic Chemistry, 409, 1994, 107-110.

3) S. Dev, K. Imagawa, Y. Mizobe, G. Cheng, and M. Hidai, Organomettalics, 1989, 8, 1232-1237.

4) S. Dev, E. Ramli, T.B. Rauchfuss and S.R. Wilson, Inorg. Chem., 30, 1991, 2514-2516.

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

References for Publications are available upon request.

PRESENTATION

Presented a few papers in national and international conferences, USA and Japan

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