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Click here or scroll down to respond to this candidateCandidate's Name
Phone: PHONE NUMBER AVAILABLEEMAIL AVAILABLEGeneral:Having more than 20 years of experience in pharmaceutical industry in analytical method development, method validation related activity for drug substance and drug products. Supervisory level experience of more than 12 years to guide, mentor and train subordinates in AR&D and Quality Control Department.Skill:Analytical Method Development, Method Validation, Method Transfer, Method Evaluation and Method enhancement using sophisticated instrument, like HPLC, GC, UV-VIS, Dissolution apparatus, Autotitrator etc.Method verification and method equivalency study as per USP monograph changes.Provide supporting documents to Regulatory department for ANDA and NDA submissions.Served as a subject matter expert (SME) during prior approval FDA inspections.Hands on Experience on Empower -2/3, Chemstation, totalchrom, Trackwise, DCM, EDMS, VEEVA, Labware software.Work closely all the time with Quality Assurance and Regulatory Affairs department to executes investigations, deficiency letter response and related action items.Provides leadership, mentor, and evaluate the performance of direct report of analysts.Prepare/ Review of standard operating procedures, method validation protocol, report and analytical methods.Calibration, validation and maintenance of the instrument.Having experience for investigation, repeat analysis, lab event, OOS/OOT during method validation/verification, method transfer, release testing of Raw Materials, Finished Product and Stability Samples using Trackwise software.Review of technical informations from API manufacturers.Review of FDA deficiency letters and planning / execution of corrective actions for deficiency response.Work Experience:Cosette Pharmaceutical, South Plainfield, NJ July 2021 to PresentSenior Manager-Analytical R&DResponsible to manage team of 6 (Scientist/Senior Scientist) in Analytical R&D for method development, method validation /verification, and routine release testing to support formulation department the Drug Substances and Finished Products (Semi Solid dosage forms such as Cream, Gels and Ointment).Scheduling, Work assignment and mentoring analytical scientists to perform the activities such as development and validation of stability indicating analytical methods for Active Ingredients and Finished dosage forms. Plan for the release and testing of R&D /Pilot and their stability testing in support of ANDA/NDA submissions.Attending project meetings for new NDAs/ANDAs as a representative of AR&D team for the purpose of planning and execution of tasks to complete them in a timely manner to file the ANDAs.Handling deviation / Investigation by close co-ordination with QA. The activities include mentoring scientists by designing experiments to find out the route cause, pragmatically writing a deviation report and follow up until the quality approval of deviation.Preparing Technical reports for the activities like Specification Justifications, method comparison and technical justifications.Writing a quality overall summary and other submission module documents for the analytical activities of new ANDAs. Submission of documents to Regulatory for submissions.Review of FDA deficiency letters and planning / execution of corrective actions for deficiency response.Review of Technical Preparation and Review of USP <467> report for the drug products to demonstrate the compliance of the drug product to USP general chapter <467> requirements.Review of Technical information documents from the API manufacturers.Facilitating method transfer between two sites of company and also from Analytical development to Quality Control laboratory within the same site.Preparation / Review/Approval of Method Validation /verification & Method Transfer Protocols and Reports.Having experience with USP general chapter <661> for the plastic CCS, especially for the Extractable and Leachable studies with the help of contract analytical laboratory.Conduct interviews of candidates for open positions and make appropriate staffing recommendations.Evaluate performance via performance appraisals including employees under development plans.Hikma Pharmaceutical, Cherry Hill, NJ Dec 2019 to July 2021Manager-Chemistry Operation (Quality Control)Responsible to manage team of 2 supervisors and about 20 chemists/technician for analysis and release of raw materials, in-process, finished product and stability of injectable dosages form.Preparation/Review/Approve of method validation/verification and method transfer protocols and reports.Ensure that non-compliant situations are thoroughly investigated like OOS and OOT as per FDA guidelines.According to the USP changes, prepare, review and execute the protocol for method verification or method equivalency for each impacted products. Implement any changes as per current USP.Manage Method remediation activity when and as needed for raw material and finished product for injectable.Prepare, review and approval of analytical methods, SOPs, method validation protocols, reports and investigations.Ensure compliance with testing SOPs and specifications.Assure employees are properly trained and audited.Assure that any discrepancies are investigated thoroughly and in a timely manner.Monitoring inventory and control of DEA control substances.Support to customer complains.Direct participation in FDA and customer audit. Providing data APR data to QA and Regulatory department.Coordinate with metrology department for IQ, OQ, PQ and routine maintenance of analytical equipment.Monitoring cleaning validation, data evaluation and provide results to manufacturing department.Field alert reporting in conjunction with QA and RA in case OOS confirmed for commercial stability samples.Places lots on HOLD if Quality issues are detected and notify senior managementIdentify potential risks associated with laboratory operations and lead teams to resolve lab issues.Work with teams of business units and meeting operational goals.Provide directions to team using Quality Laboratory short-term objectives, general policies and management guidance related to lab operation.Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.Amneal Pharmaceutical, Piscataway, NJ October 2018 to Dec 2019Group Leader (Manager) Quality Control DepartmentLead team of the analysts to test and release Raw Material, Finished Product and stability samples using HPLC, GC and other compendial/Non-compendial techniques with following cGMP requirements.Scheduling work assignment and plan for the testing of R&D/Pilot/ Exhibit batches and their stability testing in support of ANDA/NDA Submissions as per FDA, DEA and company quality requirements.Scheduling work assignment and monitoring analysts activities such as development and validation of stability indicating analytical methods for drug substance and drug product.Preparation/Review of method validation/verification, method transfer protocols/reports, SOPs, methods and specifications.Review of FDA deficiency letters and planning/ execution of corrective action for deficiency response.Facilitating method transfer between two sites of company and also from Analytical development department to Quality control department within the same site.Providing all required supporting documents to Regulatory department for ANDA submissions in timely manner.According to the USP changes, prepare, review and execute the protocol for method verification or method equivalency for each impacted products. Implement any changes as per current USP.Ensures that department maintains cGMPs, and follows the SOPs, FDA, ICH and DEA regulations.Provides leadership, mentor, and evaluate the performance of direct report of analysts.Investigate any deviation, repeat analysis, OOS/OOT during method validation/verification, method transfer and Exhibit batch testing using Trackwise software.Sun pharmaceutical, Cranbury, NJ July 2016 to Sep 2018Manager - Analytical R&D DepartmentPreparation/Review of method validation/verification and method transfer protocols and reports.Manage group of analysts for method development, method validation/verification, method equivalency, method transfer of drug substance and drug product using HPLC, GC and other compendial/Non- compendial techniques.Scheduling work assignment and monitoring analysts activities such as development and validation of stability indicating analytical methods for drug substance and drug product in support of ANDA/NDA Submissions.Facilitating method transfer between two sites of company and also from Analytical development department to Quality control department within the same site.According to the USP changes, prepare, review and execute the protocol for method verification or method equivalency for each impacted products. Implement any changes as per current USP.Troubleshooting of the problems for the analysts, if arises during the above mentioned activities.Preparation/Review of justification reports for establishment of specification for drug substance and drug product.Preparation/Review of post validated analytical method for drug substance and drug product for QC department.Preparation/review of the residual solvent report for drug product as per USP general chapter <467>.Providing supporting documents to Regulatory department for NDA/ANDA submissions as per request.Served as a subject matter expert (SME) during prior approval FDA inspections for all GMP related activity including method validation/verification, method equivalency and method transfer.Review of technical informations from API manufacturers.Sun pharmaceutical, Cranbury NJ March 2014 to Jun 2016Supervisor - Quality Control DepartmentSupervise group of 8 analysts with responsibility to assign and troubleshoot any issue during analysis and release of raw material, in-process, finished product and stability of drug products.Review and approve raw material, in-process, finished product and stability sample analysis release reports.Review and approve process validation and cleaning validation protocols and reports.Managing reference standard program, stability program, ANDA documentation and laboratory compliance program.Having in-depth knowledge and experience in Trackwise software for OOS/OOT, CAPA, Lab event, incident and Change control module.Having in-depth knowledge and experience in chromatography (HPLC, GC) with Empower 2/3 data acquisition software including to create the custom field for the auto calculation in Empower 2/3 software.In-depth knowledge and understanding of ICH, USP, EP, GLPs, cGMPs, FDA, DEA regulations and ANDA filing requirements.Served as a subject matter expert (SME) during prior approval FDA inspections in QC department.Providing supporting documents to Regulatory department for ANDA submissions.Coordinate with metrology group for equipment qualifications, calibrations and preventive maintenance program as needed.Work Experience:Sun pharmaceutical, Cranbury NJ March 2007 to February 2014Senior Chemist - AR&D DepartmentWorked on method development, method validation and method transfer of the stability indicating analytical method for Raw material and finished product by using sophisticated instruments. i.e. HPLC, UV, FTIR, Dissolution apparatusetc.Support to the formulation development department with the excipient compatibility studies and reverse engineering analysis for the new product development.Work closely with Quality control department for troubleshooting problems related to execution of test methods.Responsible to prepare, review of analytical methods, SOPs, method validation protocols, reports, reference standard qualification reports and deficiency reports.Perform IQ, OQ, PQ and routine maintenance of analytical equipment.Having knowledge to generate specification for new raw materials and finished formulations.Investigate method performance, reliability and improvement issues and evaluates proposed changes to compendial or in-house methods.Prepare Residual solvent evaluation report as per USP <467> for the drug products.Audited and reviews laboratory data generated for method validation, method transfer and method verification.Actavis Totowa, NJ January 2006 to February 2007Research scientistAble to generate protocols, reports and supporting documentation for validation and stability sample analysis.Preparation of standard operating procedure and method of analysis.Development of stability indicating analytical method by using sophisticated instruments. i.e. HPLC, UV, FTIR, Dissolution apparatusetc.Method evolution and method validation for cleaning.Able to supervise and train junior level chemists/technicians on laboratory techniques, sample preparation, instrumentation, documentation, safety, and regulatory compliance.Sun pharmaceutical Advanced Research center (SPARC), India June-2001 to December 2005Research OfficerOperation of all types of sophisticated instruments, i.e. HPLC, UV Spectrophotometer, FTIR, DSC, Autotitrator, etc.Method development and validation for raw material and finished product.Utilize HPLC, UV- Spectrophotometer, LC-MS, FT-IR, Preparative HPLC, DSC, for Impurity profiles and polymorphism study.Cadila health care limited, India Nov-1999 to May 2001ScientistOperation of all types of sophisticated instruments, i.e. HPLC, UV Spectrophotometer, FTIR, Autotitrator, etc.EducationMS in organic chemistry, S.P.University, IndiaBS in chemistry, S.P.University, IndiaDiploma in computer softwareTraining/ Seminars:Validation of liquid chromatography systems conducted by Waters.Attended training for Empower 2/3 advanced: acquisition, processing & Reviewing Results conducted by watersTraining provided by Lachman consultant to improve quality and compliance standard in pharmaceutical industriesPUBLICATION(S)An Introduction to Forced Degradation Studies for Drug Substance & Drug Product on https://www.pharmaceuticalonline.com/ and https://www.pharmaceuticalonline.com/doc/an-introduction-to-forced-degradation-studies-for-drug-substance-drug-product-0001 January 09,2020 |
