BHASKAR PATEL

**** ***** ******

Croydon PA *****

(C) 732-***-****

adczks@r.postjobfree.com

Objective:

Looking for a suitable position in Pharmaceutical Quality Control, QC Technical Services, Product Development, Research and development or Quality Assurance Department where my extensive leadership and technical skills will enable me to make the same valuable contributions as I have for my previous employers.

Summary:

Extensive records of success to manage product, process and people for Amneal Pharmaceuticals Inc., Norwich Pharmaceutical Inc. and URL Pharma. Excel at managing and training technical personnel, including Managers, supervisors, analysts, scientists, technicians and QA personnel. Experienced in cGMP compliance review, quality audit review as well as API, Excipient and drug product analysis. Extensive theoretical knowledge of Analytical, Pharmaceutical, Polymer, Heterocyclic, Organic, Unit Process, Unit Operation and General Chemistry as well as strong background of DMF review, FDA, USP, EP, cGMP and ICH guidelines. I also have comprehensive expertise in the validation, analysis and qualification of pharmaceutical drug substance and drug product, excipients and reference standards. Professional Experience:

Amneal Pharmaceutical Inc. Brookhaven, NY

Associate Director (QC Tech. Service) March 2019 –Today Sr. Manager (QC Tech. Service) August 2015- February 2019

Direct, coordinate and prioritize routine activities of group projects; assign staff to ensure project timeline are met.

Work in compliance with cGMP/cGLP regulations. Ensure all work within project group is in accordance with cGMP, SOPs, FDA, DEA regulations, ICH guidelines, OSHA and safety procedures.

Work with CMO and contract laboratories.

Conduct, manage investigations, OOS, OOT, OOAL and draw conclusion as well as CAPA.

Represent the group in meetings with scientific, technical, regulatory, research and development, product development.

Analytical method development and validation for Assay, Related compounds, Particle Size analysis, Residual solvents, Dissolution and other test for API, Excipients and Drug product.

Participate in the setting of product specifications.

Participate in CMC deficiencies responses to support project approval.

Reviewed technical documentation in support of regulatory filings and participate in ANDA, NDA submissions and internal quality audit.

Reviewed proposed USP monographs to determine suitability for use and potential impact on internal test procedures. Assisted QA/QC in monograph method qualifications.

Provide technical assistance to other departments like Formulation Development, Regulatory Affairs, Production, Supply Chain and QA to support timely new product development/submission of new ANDAs, NDA, PAS and CB30.

Review and approve process validation and cleaning validation protocols, reports and batch records.

Present analytical data and communicate issues related to projects to lab management for review and discussion.

Troubleshooting and improve existing analytical methods when necessary.

Present and discuss strategies to subordinates.

Oversee training program of Lab staff. Mentor direct reports in areas where improvement is in need and faster growth.

Participate in selection, evaluation and development of new personnel. Selected Accomplishments:

Facilitated more than $1800M in new revenues by enabling the on-time launch of 37 new products.

Submitted and approved 140+CBE 30, PAS and CBE 0.

Improved efficiency and prevented LIRs by providing critical recommendations for updating analytical methods to consolidate all tests into one method.

Developed effective training modules for new hires. Amneal Pharmaceutical Inc. Brookhaven, NY

Manager (QC Tech. Service) January 2014-August 2015

Designed protocols, prepared reports for cGMP studies and reviewed reports, protocols and test methods.

Directed method validation for assays, related compound-degradation product, Dissolution, Residual Solvent and cleaning sample. Determined necessary tests, including linearity, precision, specificity, accuracy and recovery, limit of quantitation, limit of detection, stability of standard and sample solution.

Authored reports, protocols for validation studies, analytical methods and method transfer protocols and reports.

Provided vital support for R&D, Manufacturing and QA/QC departments on method-related issues relating to market stability monitoring and release testing.

Review proposed USP monographs to determine suitability for use and potential impact on, internal test procedures. Assisted QA/QC in monograph method qualifications.

Conducted cGMP peer reviews, performed reference standard qualifications, and carried out troubleshooting of validation studies.

Lead high-level problem solving and root cause analyses. Determined Corrective and Preventive Action (CAPA).

Improved efficiency and prevented LIRs by providing critical recommendations for updating analytical methods to consolidate all tests into one method.

Managed laboratory maintenance and cleanliness, removal of expired reagents, reagent and supply ordering and HPLC/UPLC/GC columns, impurities and reference standards Norwich Pharmaceutical, Norwich, NY

Research Scientist: Product Development & Tech. Services, June 2013-January 2014.

Oversaw experimental design and managed the execution of pilot batches, validation batches, bio-batches, and FDA submission batches for $100M contract manufacturing firm.

Served as an auditor for analytical method, method transfer, finished product, API, and excipient data.

Directed method validation for assays, related compound, degradation product, cleaning methods, stability samples, and other processes. Determined necessary tests, including linearity, precision, specificity, accuracy and recovery, limit of quantitation, limit of detection, stability of standard and sample solution and others.

Lead high-level problem solving and root cause analyses. Determined Corrective and Preventive Action (CAPA).

Prepared protocols and reports for method validation studies as well as review batch protocols and reports.

Provided manufacturing process development and validation support, identified in-control and out-of-control processes, formulated quality and production improvement plans, and assisted with GMP and cGMP activities.

Managed laboratory maintenance and cleanliness, removal of expired reagents, reagent and supply ordering, and HPLC/GC/UPLC columns, Impurities and Reference Standards. Also assisted with laboratory room design and equipment selection.

Trained and supervised staff of 5-8 chemists, analysts, and technicians. Selected Accomplishments:

Improved efficiency and prevented LIRs by providing critical recommendations for updating analytical methods to consolidate all tests into one method.

Saved 1000’s of dollar amount by qualifying in-house standards during phase I of projects.

Increased analyst output 10% by introducing Empower 3 techniques into the analytical data acquisition process.

Enhanced productivity by developing effective training modules for new hires. URL Pharma, Philadelphia, PA

Scientist – Chemistry & Manufacturing Services Dept. (2010- June 2013) Analytical Chemist – Quality Engineering & Technical Services (2006-2010) Analytical Chemist – AR&D (July 2004-2006)

Managed projects for ANDA, NDA, and FDA deficiency submissions at manufacturing and marketing of generic and brand product.

Designed experiments and protocols, prepared reports for cGMP studies, and reviewed reports, protocols, and test methods. Actively involved in pilot batch, validation batch, bio-batch, and submission batch activities.

Authored protocols and reports on process, method, and cleaning validation, and method transfer.

Conducted cGMP peer reviews, performed reference standard qualifications, and carried out troubleshooting of validation studies. Also participated in OOS investigations.

Calculated maximum allowable carryover (MAC) residue limits for active ingredients and detergents.

Performed investigations, CAPAs, root cause identification, and reporting on analytical methods and protocols for API/excipient, cleaning sample, drug products and batch data.

Provided vital support for R&D, Manufacturing, and QA/QC departments on method-related issues relating to market stability monitoring and release testing.

Reviewed proposed USP monographs to determine suitability for, and potential impact on, internal test procedures. Assisted QA/QC in monograph method qualifications.

Member of company-wide Compliance Department Auditing Team. Selected Accomplishments:

Promoted rapidly through increasingly responsible positions to laboratory leadership role.

Played key role in updating analytical methods to improve efficiency and eliminate LIRs.

Facilitated $800M in new revenues by enabling the on-time launch of three new products.

Saved more than $100,000 by qualifying in-house standards during Phase I-Phase III of projects.

Enabled $20,000 in savings by negotiating pricing for outsourcing of API and excipient testing. Education:

Ph.D. Organic chemistry, S.P. University, India

MS Organic Chemistry, S.P. University, India

BS Industrial Chemistry, S.P. University, India

Equipment:

HPLC, UPLC, GC, Dissolution, IR, UV/VIS. DSC, TGA, TLC, AAS, ICP-MS, ICP-OES, pH meter, Autotitrator, Balances and Wet chemistry.

Technical Skills:

Computers: MS Office, Agilent software, Millennium software, Empower 1/2/3, Compliance Wire, Pharma Ready, SAP and Qumas software

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