Director, Manufacturing & Quality @ Merck & Co.Inc
St. John's University
Dynamic Biotech professional with 15 years experience in Pharmaceutical/Biotech Industry with expertise in Process Development, Quality Assurance, Quality Control, Validation, Tech Transfer, Compliance, Regulatory Affairs and Operational Excellence. Solution-oriented and versatile professional with solid regulatory agency expertise including FDA, EMA, TGA, Turkey MOH, PMDA, MHRA, Health Canada, and IFANCA. Proven experience with compliance audits and preparing reviews
Dynamic Biotech professional with 15 years experience in Pharmaceutical/Biotech Industry with expertise in Process Development, Quality Assurance, Quality Control, Validation, Tech Transfer, Compliance, Regulatory Affairs and Operational Excellence. Solution-oriented and versatile professional with solid regulatory agency expertise including FDA, EMA, TGA, Turkey MOH, PMDA, MHRA, Health Canada, and IFANCA. Proven experience with compliance audits and preparing reviews and responses to audit observations. Strong communicator skilled at consultation and fostering positive relationships. Solid technical knowledge of cGMP’s and achieving regulatory compliance for sterile biologics product manufacturing. Strong validation experience including master plans, equipment qualification/instrument qualification, URS, FRS, Design specs, Impact assessment, IQ, OQ, and PQ process validation. Skilled in team building, management, and achieving production goals and quality.
Specialties: Process Development, Quality Assurance, Compliance, Manufacturing, Quality Control, Regulatory Affairs, Operational Excellence, Tech Transfer and Validation
Workflow Optimization Quality Risk Management Project Management Regulatory compliance Communication Biotech (Aseptic )Manufacturing Investigations and CAPA Technology Development Leadership/Team Building
Associate Director of Engineering, Process Technology Lead, Technology Integration @ Innovation Lead for Sterile processing strategy – developed strategic vision for sterile manufacturing and system wide development and deployment of technical solutions
Lead Process Technology Team focused on identification and strategic implementation of new technologies to enable efficient and reliable solutions for manufacturing.
Develop filing content and strategy including dossier authoring, audit/review of regulatory submission documents for Vaccines and Biologics
Provide technical support to Sites in relation to Regulatory inspections, develop response to inspection observations, and identify effective corrective and preventative actions in response to critical manufacturing investigations
Drive standardization across the Merck network in alignment with “Single Use Network” initiatives. Lead transformation efforts, sterile envelope initiatives and process improvement projects within Vaccine Manufacturing, focusing on enhancements to aseptic processing and sterility assurance.
Serve as a member of Technology Leadership Team and ensure alignment of Site, divisional and corporate strategies. Provide direction and technical expertise to the Integrated Process Teams to establish and develop tactical plans that support site/network strategies and deliver value/business objectives. From January 2011 to Present (5 years) Quality Assurance Manager (Drug Substance QA) @ Provided leadership to cross-functional team handling the technical transfer of the polysaccharide process for cross licensing of serotypes. Performed quality assurance oversight for technical documents, process description reports, process evaluation, critical process parameter analysis, provisional limits, clinical trial material compatibility for batches, technical transfer plans, manufacturing demonstrations, and preparing common technical document sections for regulatory submissions.
Successfully integrated Quality Risk Management and Operational excellence to establish a consistent Filter Integrity testing paradigm with product quality as the focal point.
Provide Quality Systems oversight to Manufacturing Science & Technology through review and approval of batch records, technical documents, standard operating procedures, risk assessments, commitments, and walkthrough audits. From December 2008 to December 2010 (2 years 1 month) Manager Quality Assurance (Investigations & Compliance) @ Established Compliance program to support Commercial Operations through management of investigations and Commitments. Drive CAPA initiatives to reduce the probability of recurring nonconformities/events.
Implemented and trained on the use of Investigations Quality Assessment tool that reduced compliance risk and ensured high quality investigations for deviations including root cause identification and trend analysis.
Interacted directly with regulatory agencies in resolving inspectional issues; participate in internal, regulatory and corporate compliance audits, prepare response to audit observation and correct deficiencies as required. From February 2007 to November 2008 (1 year 10 months) Senior QA Validation Specialist I - QA Team Leader @ Collaborated with Technology for Operational Excellence Project that improved review process, reduced overall Validation Lead-Time by 30%.
Provided leadership on review of Validation documents with FDA and Corporate auditors. Performed Quality Audit for Vaccines Formulation and Fill/Finish Operations to assess the Validation Status of all cleaning, process, method, equipment/instruments used in manufacturing.
Project lead for Media Simulation sub-team to Aseptic Processing User Group to foster greater collaboration and share best practices amongst different Wyeth sites on Process Simulations. From April 2004 to January 2007 (2 years 10 months) Senior Manufacturing Scientist (Product & Process Improvement) @ Lead a significant effort to start up Pilot Scale and Analytical Laboratory in compliance with cGMP guidelines.
Developed and qualified new methods for in-process testing of vaccine products that improved process monitoring.
Performed equipment/instrument qualifications, personnel qualification and assay validation studies that effectively supported manufacturing and provided substantial financial savings to the company. From April 2001 to April 2004 (3 years 1 month) QC Laboratory Supervisor @ Supervised Quality Control laboratory operations ensuring compliance with environmental and safety regulations.
Oversee staffing and training, reviewed analytical protocols, reports and study documentation (notebooks, instrument output, etc.) for accuracy, completeness, and conformance with GLP requirements, as appropriate.
Reviewed "Laboratory Investigation" reports to track and trend deviations, change controls and report metrics.
Trained personnel in analytical methods, equipment operation and new analytical techniques. From December 2000 to April 2001 (5 months) QC Analyst @ Conducted analyses, calculations and documented in accordance with STP's/SOP's for use by PGM labs.
Monitored trends collaborated with manufacturing to address deviations, generated periodic reports to management.
Performed qualitative/quantitative analyses with emphasis on NIR, UV/Visible Spectroscopy, IR-Spectroscopy, FTIR, Electrophoresis techniques, ultra filtration and chromatographic techniques particularly TLC, HPLC, and GC.
Performed stability testing on a variety of drug products and investigated stability failures. From April 2000 to November 2000 (8 months)
M.B.A, Management (Hagan School of Business Management) @ Iona CollegeMaster of Science, Pharmacology @ Saint John's UniversityMaster of Science, Biology (Microbiology) @ Visva-Bharati Mousumi Paul is skilled in: GMP, Quality System, Quality Assurance, Validation, CAPA, HPLC, Regulatory Affairs, FDA, Process Improvement, Technology Transfer, Manufacturing, Clinical Trials, Cross-functional Team Leadership, Sop, GLP
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