ABHAY S. PAWAR
Draper,USA
Summary
Twenty-five (25) years of ‘hands on’ experience in Formulation Development, Pre-formulation, Stability, Scale up, Pilot batch, Preformulation, Bio batches, Tech transfer, contract manufacturing organizational and documentation for Generic products. Developed and worked on different type of formulation process such as Wet / dry granulation, Compaction, Compression coated tablets, Pellets, Controlled release, Liquids and Semisolids. Hands on experience on different manufacturing equipment’s such as high shear granulator, compactor, different compression and coating machine, fluid bed coater as well as analytical equipment dissolution appts, UV-VIS, HPLC, DSC and PAT. Knowledge and Understanding of guidelines such as SUPAC, FDA, HFBFI, Patent evaluation, Bio equivalence, ICH and statistical analysis (JMP).
Overview
27
27
years of professional experience
Work History
Associate Director Manufacturing Science and Technology
TEVA USA
2021.03 - Current
- Responsible for providing direction, coordinating project tasks, team responsibilities and timelines and assure results are produced.
- Responsible for assisting with the establishment of departmental goals and monitor goal attainment against established performance measurements to effectively accomplish specific team goals and objectives.
- Represented MS&T for the site in internal and external teams for product transfer, contract manufacturing organization (CMO) support including investigations and process improvement plans.
- Trained employees on equipment and analytical processes including statistical principles for continued process verification (CPV).
- Provide assistance in troubleshooting to manufacturing and packaging areas.
- Responsible for the design and execution of experiments to optimize and scale-up drug process operations such as blending, compression, granulation and coating of solid dose formulations by supporting current and any new and transfer product lines.
- Responsible for preparing and/or reviewing documents to support projects such as change controls, protocols, master batch records, investigation reports, SOP’s, etc.
- Responsible for providing technical support in the investigation of manufacturing incidents and deviations and performing investigations as needed.
- Responsible for leading and executing projects designed to improve quality and safety, reduce costs and improve efficiency.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
Manager Manufacturing Science and Technology
TEVA USA
2019.08 - 2021.03
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
- Interface with Quality Assurance and Research and Development (R&D) on process requirements for new and current products.
- Work in conjunction with maintenance department to identify, recommend and implement the upgrade of current equipment and the purchase of new equipment within regulatory requirements.
- Perform studies to support necessary equipment and system IQ, OQ, and PQ’s to assure compliance in all manufacturing and support areas.
- Assist with on-site transfer projects and product scale-up activities.
- Recommend improvements in manufacturing and control systems.
- Review mechanical specifications in manufacturer and blue print form and identify critical parameters.
- Analyze statistical data, product or functional specifications to determine conformance with standards and established quality requirements.
- Review and approve protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
- Assure that protocols are approved through proper channels; writes and revises validation protocols. Executes validation protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
- Analyze data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
- Write final reports and assures that they are approved through proper channels.
- Coordinate resources from engineering, research and development, technical services, quality assurance and production personnel assigned to specific projects. Develop and communicate project timelines and status.
- Review investigation reports, protocols batch records and CMC documentation.
- Provide timely updates to management on the status of various projects.
- Provide technical training and assistance to others.
- Comply with all GMP and safety requirements, SOP’s and Company policies and procedures.
Senior R&D Chemist- Production
TEVA USA
2013.12 - 2019.08
- Review batch data, planning and manufacturing technical transfer and scale up batches.
- R&D Project management involving the generation of characterization protocols and reports, justification of manufacturing incidents and deviations and preparation of FDA submission documents.
- Provide expert assistance on technical issues in connection with confirming or establishing critical operating parameters for site transfer projects and process validation campaigns as to manufacture scale-up/characterization batches.
- Involve in early formulation development and process optimization for new R&D products until product submission to FDA.
- Execute post approval projects such as process improvements, scale-ups and scale-down of new products from optimization to validation activities.
- Develop and/or execute experimental designs and approaches to resolve complex technical problems for post approved R&D products.
- Provide technical support for validation of new products as well as site transfer products.
- Initiate/Reviews/approve validation protocols and reports to ensure compliance for In-house as well as third party products.
- Interact with external raw material vendors in for process improvement projects.
- Initiate, review and approve documents to projects and regulatory submissions such as investigation reports, change request, protocols and technical services reports, validation report and commercial as well as technical services master batch records.
- Monitor manufacturing and responsible for submission batches related to scale-up/down, alternate equipment, alternate API and reformulation for US, Canada and Israel market.
- Lead multi-functional Root Cause Analysis Investigations for major process/product problems and implement corrective actions.
- Works only under general direction and able to work in a team based organization.
Process Engineering Specialist
TEVA CANADA
2009.12 - 2013.12
- Lead and execute projects such as process improvements, scale-ups and scale-down of existing products to Manufacturing.
- Supervise one (1) Technologist; Designs manufacturing processes for new products and reformulation of existing products.
- Develop and/or execute experimental designs and approaches to resolve complex technical problems and accomplish project goals.
- Organize and execute qualifications for alternate suppliers of API and excipients.
- Provide technical support for validation of commercial products, site transfer products and investigation for regular commercial products.
- Interact with external raw material vendors in order to production process improvement projects.
- Initiate, review and approve documents to support technical projects and regulatory submissions such as investigation reports, change request, protocols and technical services reports, validation report and commercial as well as technical services master batch records.
- Monitor manufacturing and responsible for submission batches related to scale-up/down, alternate equipment, alternate API and reformulation for US, Canada and Israel market.
- Lead and manage hold time product portfolio for Davie site.
- Lead multi-functional Root Cause Analysis Investigations for major process/product problems and implement corrective actions.
- Assist staff and guide for meeting their goals and interact with other department to resolve any issues.
- Represents R department for steering meeting group for technical services project discussion.
- Works only under general direction and able to work in a team based organization.
Formulation Scientist
TEVA NOVOPHARM, CANADA
2008.09 - 2009.03
- Supervise five (5) Technologists and provide necessary input for executing development trial and submission batches.
- Search literature; evaluate patents to establish the appropriate formula and process.
- Search for excipients suppliers for the formulation development.
- Design pre formulation studies and formulation development trials for new product development for conventional and controlled release dosage forms.
- Design, issue and evaluate formulation trials to develop optimized formula and manufacturing processes.
- Coordinates and executes assigned projects and activities; develops project goals.
- Review, write protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for Abbreviated New Drug Applications (ANDA’s) submission to regulatory agency.
- Evaluate formulation trial and analytical data and discuss with manager to decide on the further formulation development.
- Prepare biweekly development summary, bio results and present at formulation meeting R&D group.
- Provides scientific and technical directions to Technicians to ensure project deadlines and standards are met. Collaborates with supervisor to set priorities and reach objectives.
- Evaluates the bioequivalence data discussion meeting and recommend changes in formulation.
- Prepare and present formulation development report at pre submission meeting with technical services.
- Prepares pharmaceutical product development report (PDR) ,Quality overall Summary (QOS) for regulatory filing.
Scientific Leader Formulation Development New Products
APOTEX PHARMACEUTICAL INC, CANADA
2007.08 - 2008.09
- Indirectly supervise up to ten (10) Technicians; executing development trial, optimization and submission batches.
- Search literature, patents to establish the appropriate formula and process.
- Search for excipients suppliers for the formulation development.
- Design pre formulation studies and formulation development trials for new product development.
- Design, issue and evaluate formulation trials to develop optimized formula and manufacturing processes.
- Schedule and coordinate all formulation development activities including initial to submission batches to ensure that projects are completed on target time.
- Evaluate formulation and analytical data and discuss with manager to decide on the further formulation development.
- Trouble-shoot and scale-up the Formula/Processes based on scientific approach.
- Prepare biweekly reports and meeting with management.
- Review and approve formulation development master documents and commercial Scale-up documents.
- Compile formulation data and assist cross functional teams for deficiency reply to regulatory agency.
- Evaluation of tech-transfer project and necessary scale-up trials.
- Co-ordinate and attend cross functional meeting.
Formulation Scientist
COBALT PHARMACEUTICAL, CANADA
2006.08 - 2007.08
- Reporting to the Director of R&D, supervise one (1) R&D Assistant.
- Execute manufacturing processes in accordance with manufacturing Batch records.
- Search literature to establish the appropriate formula/process.
- Search for API and excipients suppliers for the formulation development.
- Search for new equipments and processing and ordering for formulation lab.
- Co-ordinate with engineering for IQ/OQ and calibration of the new equipment installations.
- Design pre formulation studies and formulation development trials for new product development.
- Report formulation activities, coordinate analytical laboratory testing and report results.
- Prepare weekly reports and meeting with analytical department.
- Prepare development report.
- Evaluation of tech-transfer project and necessary scale-up trials.
- Project manager for PAT project.
Manufacturing Operator
COBALT PHARMACEUTICAL, CANADA
2006.02 - 2006.08
- Dispensing of manufacturing batches as per Standard operating procedure and Bill of material.
- Perform machine, changeover, cleaning and set up as required.
- Operate various manufacturing equipment of Granulation, Blending and Coating area and ensure adherence to quality standards during all stages of the manufacturing process.
- Complete manufacturing documents, ensuring accuracy with compliance at all times with related SOPs and GMPs in the manufacturing process.
- Perform and coordinate Process validation of new product manufacture.
- Assist and support team member for manufacturing and validation batches.
- Cleaning and sanitization of equipment and manufacturing room.
Executive R&D, [Scientist Group Leader]
OMAN PHARMACEUTICAL PRODUCTS, OMAN
2003.12 - 2004.09
- Preparation of Standard Operating Procedures and Work instruction procedures to ensure product quality.
- Design pre formulation studies and formulation development for new product development.
- Preparation of master, batch manufacturing and product specifications.
- Scale up of Solid, Semisolid, Liquid and Sustain release Formulations.
- Assist teams member for new product development, lab scale, pilot, stability, and full scale batches of solid dose, Semisolid and liquid formulations.
- Vender development of Active pharmaceutical Ingredients & Non Active pharmaceutical Ingredients.
- Assist and support manufacturing team for product process transfer and manufacturing.
Executive R&D, [Scientist Group Leader]
DR.REDDY’S LABORATORIES, INDIA
2002.10 - 2003.12
- Supervised six (6) Scientists; responsible for training, couching and performance reviews.
- Preparation of Standard Operating Procedures, Departmental Operating Procedures and Work instruction to ensure product quality.
- Plan and Design pre formulation studies and formulation development for new product with formulations scientist.
- Formulation Development and Scale up of Solid, Semisolid, Liquid and Sustain release Formulations such as Tablet, capsule, ointment, liquids pellets and gels.
- Team member for new product development, lab scale, pilot, stability, bio, and full scale batches of solid dose products.
- Assist technology transfer and Validation team for Manufacturing of New product and trouble shooting for large production batches.
- Vender development of Active pharmaceutical Ingredients and Non Active pharmaceutical Ingredients.
- Organized technical meeting for New Product launch at launch location. Worked with New product development team for Successful manufacture and transfer of New Products.
- Worked and supported Regulatory team for necessary documentation and successful submission of New Products.
Scientist I
EMCURE PHARMACEUTICAL, INDIA
1998.12 - 2002.09
- Preparation of Standard Operating Procedures and Departmental Operating Procedures to ensure product quality.
- Preparation of protocol for Pre-formulation, Development, stability and Product, Finished specification and for the Various products.
- Design pre formulation studies and formulation development for new product development.
- Formulation and Analytical development of Solid, Semisolid, Liquid, tastes improvement, Pellets and fast dissolving formulations.
- Develop and manufacturer products at third party contract location.
- Perform HPLC, UV and Dissolution and stability testing.
- Developed Tablet in Tablet and Bi-layer as well as sustained release products.
Education
Masters in Pharmacy - Pharmaceutics
KLES’ College of Pharmacy, Belgaum Rajiv Gandhi University of Health Sciences
India2000-01
Bachelor of Pharmacy - undefined
A.B.C.P College of Pharmacy
India1996-01
Skills
- MS office (Excel, Word, Power Point, Access and MS Outlook)
- Hands of experience on SAP, Oracle, Lims and other internal software System
- Hands of experience on Gastro plus, Ppk and PAT analysis
- Completed white belt for Six Sigma
- Statistical Analysis (JMP)
Timeline
Associate Director Manufacturing Science and Technology
TEVA USA
2021.03 - Current
Manager Manufacturing Science and Technology
TEVA USA
2019.08 - 2021.03
Senior R&D Chemist- Production
TEVA USA
2013.12 - 2019.08
Process Engineering Specialist
TEVA CANADA
2009.12 - 2013.12
Formulation Scientist
TEVA NOVOPHARM, CANADA
2008.09 - 2009.03
Scientific Leader Formulation Development New Products
APOTEX PHARMACEUTICAL INC, CANADA
2007.08 - 2008.09
Formulation Scientist
COBALT PHARMACEUTICAL, CANADA
2006.08 - 2007.08
Manufacturing Operator
COBALT PHARMACEUTICAL, CANADA
2006.02 - 2006.08
Executive R&D, [Scientist Group Leader]
OMAN PHARMACEUTICAL PRODUCTS, OMAN
2003.12 - 2004.09
Executive R&D, [Scientist Group Leader]
DR.REDDY’S LABORATORIES, INDIA
2002.10 - 2003.12
Scientist I
EMCURE PHARMACEUTICAL, INDIA
1998.12 - 2002.09
Bachelor of Pharmacy - undefined
A.B.C.P College of Pharmacy
Masters in Pharmacy - Pharmaceutics
KLES’ College of Pharmacy, Belgaum Rajiv Gandhi University of Health Sciences