Md Tofique Patwary
Lake Hopatcong,NJ
Summary
Dynamic and results-oriented Production and Quality Control manager with a proven track record in the pharmaceuticals and aseptic production industry. Proficient in Good Laboratory Practice (GLP), Good Documentation Practice (GDP), Cryopreservation, and Inventory Management. Demonstrated leadership abilities with a keen focus on driving operational excellence. Possesses strong scientific acumen and technical expertise, coupled with a commitment to delivering high-quality results in a regulated environment.
Overview
9
9
years of professional experience
Work History
Supervisor Quality Control Sample Management CAR-T
Bristol Myers Squibb
Summit, NJ
11.2022 - Current
- Manage and oversee daily shift activities, including planning and scheduling. Participate in hiring, development, and performance evaluation of QC Sample Management Associates.
- Qualified trainer for shift personnel, conducting training on approved procedures and equipment.
- Perform QC test samples handling and cold supply chain throughout the CAR T manufacturing lifecycle process.
- Conducted regular audits of the manufacturing process to ensure quality standards were met.
- Participate in FDA "mock inspections" and ensure audit/inspection readiness.
- Author/revise SOPs, protocols, deviations, and CAPA.
- Proficient in conducting biological safety cabinet operations, clarification, pipetting activities within QC laboratories with comprehensive training and hands on experience.
- Assist in investigations, implement CAPAs, and process improvements.
- Review daily work, shift reports, and participate in internal and external audits.
- Maintain coordinate with external BMS sites for shipment management and oversee cryo shipment activities.
- Cultivated interpersonal skills by building positive relationships with others.
- Proven ability to develop and implement creative solutions to complex problems.
Associate Scientist QC Sample Management (CAR T)
Bristol Myers Squibb
Summit, NJ
04.2020 - 11.2022
- Executed meticulous handling of QC test samples throughout the CAR T manufacturing process.
- Coordinated seamless sample processing and meticulously maintained quality records.
- Mentored and trained junior staff in sample management procedures and equipment
- operation.
- Conducted comprehensive investigations and root cause analyses, contributing to process
- enhancements.
- Proficiently operated Bio safety cabinet (BSC) and facilitated RCA sampling initiatives.
- Utilizes expertise in biological safety cabinet (BSC) operations for clarification and
- pipetting procedures.
- Performed sample preparation activities such as centrifugation, filtration, and aliquoting.
- Conducts QC EM monitoring activities to ensure adherence to quality standards
Senior Production Support Specialist (Radiopharmac
Advanced Accelerator Application
Morris Plains, NJ
01.2019 - 04.2020
- Provides comprehensive technical support throughout the production process of
- Lutathera LU177), encompassing manual tasks, cell cleaning, and sterilization of the
- isolator using vaporized hydrogen peroxide.
- Ensures meticulous adherence to procedural guidelines while preparing materials,
- maintaining precise material identity.
- Assists in conducting deviation inspections and investigations, contributing to rigorous
- quality control measures.
- Actively engages in designated validation and qualification activities, ensuring
- compliance with regulatory standards.
- Executes the production of various radioactive materials with strict adherence to
- personal protective equipment (PPE) protocols.
- Conducts thorough area surveys and monitors radiation levels to uphold safety
- standards.
- Collaborates on packaging activities and prepares materials meticulously for final
- shipment
Production Support Specialist (Car-T Cell Therapy
Novartis Pharmaceuticals
Morris Plains, NJ
01.2017 - 01.2019
- Provided indispensable support to production operations within ISO Class 7&8 clean room environments including kitting dispensing ordering and providing supplies and growth promoting medias while maintaining COC.
- Provided technical support for production systems and applications.
- Exemplified strict adherence to SOPs in the manufacture of human blood-derived components.
- Leveraged advanced proficiency in Cryopreservation (CRF) and enterprise systems such as SAP, MES & LIMS.
- Collaborated effectively within cross-functional teams to prioritize and execute daily projects
Processing and Sterilization Specialist
MTF Biologics
Edison, NJ
01.2015 - 01.2017
- Maintained meticulous adherence to manufacturing batch records (MBR) and upheld aseptic techniques in ISO Class 5 area.
- Facilitated the provision of essential supplies and equipment for human cell tissue processing.
- Implemented robust inventory control measures and Kanban systems to ensure seam less operations.
- Executed aseptic manufacturing operations within ISO Class 8 clean room environments.
- Demonstrated expertise in Autoclave operation and the sterilization of surgical equipment.
- Oversaw inventory management and supply distribution to processing units, ensuring operational continuity
Education
Aseptic Processing Technology
Berkeley College
Little Falls, NJ01-2014
Bachelor of Science - Social Sciences
University of Asia Pacific
Dhaka, Bangladesh01-2011
High School Diploma -
Wills Little Flower School And College
Dhaka, Bangladesh01-2007
Skills
- Training And Development
- Project Management
- Production Planning
- Inspections And Audits
- Process Improvements
- Quality Control
- Sop Development
- Deviation Investigation
- Cryopreservation and Sample Management
- Technical Troubleshooting
- Logistics Planning
- Shipping management
Timeline
Supervisor Quality Control Sample Management CAR-T
Bristol Myers Squibb
11.2022 - Current
Associate Scientist QC Sample Management (CAR T)
Bristol Myers Squibb
04.2020 - 11.2022
Senior Production Support Specialist (Radiopharmac
Advanced Accelerator Application
01.2019 - 04.2020
Production Support Specialist (Car-T Cell Therapy
Novartis Pharmaceuticals
01.2017 - 01.2019
Processing and Sterilization Specialist
MTF Biologics
01.2015 - 01.2017
Aseptic Processing Technology
Berkeley College
Bachelor of Science - Social Sciences
University of Asia Pacific
High School Diploma -
Wills Little Flower School And College
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