Dipak P. Email and Phone Number

• Manage the overall planning and execution of assigned projects related to pharmaceuticalanalysis, especially in projects of supporting formulation development and CTMmanufacturing, and marketed product testing• Prepare and approve detailed project plans and study protocols, and manage staff inexecution of study protocols• Prepare, reviewing and approve technical reports and SOP’s, SOP deviations, Out-ofSpecification (OOS) investigation reports and change control… Show more • Manage the overall planning and execution of assigned projects related to pharmaceuticalanalysis, especially in projects of supporting formulation development and CTMmanufacturing, and marketed product testing• Prepare and approve detailed project plans and study protocols, and manage staff inexecution of study protocols• Prepare, reviewing and approve technical reports and SOP’s, SOP deviations, Out-ofSpecification (OOS) investigation reports and change control documentations• Provide technical guidance to help team solve challenging technical problems• Estimate resource requirements and project timelines for technical projects and assign projectresponsibilities• Coordinate communication and interact with both internal and external clients to solve anyissues• Provide technical guidance to lab staff, train staff on new equipment and technologies, andreview laboratory notebooks Show less

• Responsible for analytical laboratory and analytical scientists/technicians.• Manage method validation, method development and method transfer of sterile and nonsterile products (injectable, lotion, suspension, oral solution) per cGMP requirements.• Write and/or review and approve protocols, reports related to method development,method validation and method transfer.• Write and/or review and approve SOPs and applicable procedures.• Manage method remediation activities… Show more • Responsible for analytical laboratory and analytical scientists/technicians.• Manage method validation, method development and method transfer of sterile and nonsterile products (injectable, lotion, suspension, oral solution) per cGMP requirements.• Write and/or review and approve protocols, reports related to method development,method validation and method transfer.• Write and/or review and approve SOPs and applicable procedures.• Manage method remediation activities between R&D and commercial.• Manage timely submission of ANDA to FDA by working with various functional teams(Regulatory, QC, R&D and Project Management).• Coordinate with Regulatory, Supply chain, Manufacturing, QC and QA to ensure timelyrelease of submission, validation, and commercial batches.• Ensure timely testing of Finished Product and Stability testing.• Perform Bio-equivalency related studies for ANDA batches and participate in related audits.• Conduct eCTD review and ensuring any issues (data integrity or irregularities) are corrected.• Manage Change Controls, CAPA, Deviations, OOS and OOT using Track wise system.• Identify continuous improvements of the document process within applicable written testprocedures and methods.• Train analytical scientists and technicians.• Manage lab equipment validation (IQ, OQ, PQ) and calibration.• Prepare KPIs and metrics for the department.• Prepare and manage budget for the department.• Participate in external vendor audit and internal audit.• Participate in selection of external vendors (API and CMO).• Participate in Health Authority inspections (FDA).• Supporting IR/CRL team to complete response to Health Authority in timely manner. Show less

• Responsible for review of full eCTD, including review of batch records.• Reviewed full eCTD before filling to US FDA to identify any deficiencies in the report.• Trained analytical chemists to improve analytical data documentation & reporting.• Reviewed manufacturing batch records (MBR), Packaging batch record (PBR) ANDA,Amendments and Annual reports, Clinical reports before filling to US FDA.• Provided GAP assessment report to respective department after review of eCTD… Show more • Responsible for review of full eCTD, including review of batch records.• Reviewed full eCTD before filling to US FDA to identify any deficiencies in the report.• Trained analytical chemists to improve analytical data documentation & reporting.• Reviewed manufacturing batch records (MBR), Packaging batch record (PBR) ANDA,Amendments and Annual reports, Clinical reports before filling to US FDA.• Provided GAP assessment report to respective department after review of eCTD documents.• Coordinated and discussed with other team members for continuous quality improvements.• Identified continuous improvement of the documentation process.• Reviewed data and inventory control record to check data integrity report in SAP system. Show less

• Responsible for testing of commercial products and managing analytical scientists.• Managed testing of Finished drug product, stability, and in-process samples.• Managed equipment calibrations with external vendor and prepared contracts.• Performed and/or managed PM on various instruments.• Managed and conducted Change Control, OOS and OOT Investigations, and coordinated withQA department.• Trained scientists/technicians on new methods, data documentation and… Show more • Responsible for testing of commercial products and managing analytical scientists.• Managed testing of Finished drug product, stability, and in-process samples.• Managed equipment calibrations with external vendor and prepared contracts.• Performed and/or managed PM on various instruments.• Managed and conducted Change Control, OOS and OOT Investigations, and coordinated withQA department.• Trained scientists/technicians on new methods, data documentation and reporting.• Prepared and/or reviewed certificates of analysis for commercial release in LIMS.• Expected strict adhere to specification & test procedures by the scientists/technicians.• Identified and coordinated continuous improvement activities applicable to test proceduresand methods. Show less

• Responsible for method transfer and release of commercial product.• Performed method evaluation and method transfer of various drugs products.• Performed Dissolution testing as per USP criteria for Capsules and tablets.• Analyzed Finished drug product, stability and in process sample.• Conducted Change Controls, OOS investigations.• Performed PM and calibration on various instruments and tools.• Write SOP, protocols, reports for method transfer and equipment use.•… Show more • Responsible for method transfer and release of commercial product.• Performed method evaluation and method transfer of various drugs products.• Performed Dissolution testing as per USP criteria for Capsules and tablets.• Analyzed Finished drug product, stability and in process sample.• Conducted Change Controls, OOS investigations.• Performed PM and calibration on various instruments and tools.• Write SOP, protocols, reports for method transfer and equipment use.• Support formulation department to develop new drugs by analyzing drug Show less

• Performed Dissolution testing per USP criteria to perform the test on tablets and capsules.• Developed methods to analyze new drugs on HPLC.• Developed methods to analyze new drugs on NGI (Next Generation Impactor).

• Performed method evaluation, method development and method transfer of various drugsfor solid and liquid drug products for internal and external customers.• Performed Dissolution testing as per USP criteria for Gel capsules, Capsules, and tablets.• Conducted laboratory investigations and documentation of OOS/OOT results.• Performed review of test results for soundness, accuracy, and GLP/cGMP compliance.• Generated protocol and report for method validation.• Established… Show more • Performed method evaluation, method development and method transfer of various drugsfor solid and liquid drug products for internal and external customers.• Performed Dissolution testing as per USP criteria for Gel capsules, Capsules, and tablets.• Conducted laboratory investigations and documentation of OOS/OOT results.• Performed review of test results for soundness, accuracy, and GLP/cGMP compliance.• Generated protocol and report for method validation.• Established systems and procedures for analytical method development of solid and liquidoral formulations.• Set up analytical laboratory as per lean six sigma program and kaizen.• Supported formulation department to develop new drugs by analyzing drug on HPLC, IR, UVand KF procedures for prototypes testing, stability samples including ANDA registrationsamples and clinical samples.• Assists in development of strategic plans for departmental goals Show less