Sanjay Motipwar
Thane
Summary
Success-driven 28+ years of pharmaceutical executive experience in building and advancing highly effective product development programs and Technology transfer for immediate release, controlled release and complex solid orals, Injectable, and Topical generic formulations from concept to global commercialization. Proven expertise in QbD methodologies, risk management, and continuous improvement programs throughout the product lifecycle. Proficient in formulation and process development, scale-up, and pilot/pivotal/commercial scale manufacturing operations and technical transfer of Solid orals, Injectable, Potent drug products, and Transdermal patches to create exponential growth and true commercial success. Strong background in regulatory and cGMP compliance, Technical operation (new product launch & site transfer), ANDA submission, CMC management, Risk assessment, Investigations, Regulatory deficiencies and IR/CRL and quality systems. Excellent communication, interpersonal, and presentation skills.
Overview
28
28
years of professional experience
Work History
Vice President (Technical Services)
PAR Formulations (ENDO Inc.)
Mumbai
01.2020 - Current
- Heading Technical Services Departments Responsible for three Locations: Coordination with different Groups
- Tech
- Transfer team, R&D Digha Mumbai Team size: Director+8 Tech
- Service Team from Chennai (Solid Orals) Team size: Director+18 Tech
- Service Team from Indore (Solid Orals) Team size: Sr.Director+10 Tech
- Service Team from Indore (Sterile) Team size: AVP+18 Responsible for All activities pertaining to Technology Transfer of products from PAR USA to PAR India (Chennai and Indore) Responsible for All activities pertaining to Technology Transfer of products from PAR R&D to PAR India (Chennai and Indore) Review and finalization of Process Feasibility and Scalability
- Responsible for Process Validation for Commercial Scale batches.(New products) System development and Lifecycle managements for all TS activities
- Owning,Leading and Driving different initiatives like Manufacturing Data Management (DI), DHF, Nitrosamine assessment
General Manager Pharmaceutical Technology, Formulation & Development)
Zydus Healthcare Limited
Ahmedabad
07.2008 - 01.2020
- Project Coordination, Execution, and subsequent process development of products in all markets
- Planning and Execution of Feasibility/Scale Up/Exhibit/Pre Commercial and commercial Validation batches for all markets
- Reviewing the Pilot batches data, Master Formulation Record, Process clearance, Project COGs, and all documents for Exhibit and Commercial PPQ batches
- Responsible for Execution of Exhibit batches for all markets and all Locations
- Planning and Execution of Exhibit batches along with documentation Review and finalization of Process Feasibility and Scalability
- Coordination with different Groups
- Responsible for All activities pertaining to Technology Transfer of products from Zydus Spain and Zydus France.
- Responsible for Process Validation for Commercial Scale batches.(New products) Planning of Engineering batches.
- Batches before 6-8 M of Commercial Launch date
- Process design and Optimization on new equipment using scientific tools
- Quality risk assessment and Risk mitigation
- Process Optimization and Scale Up trials to designed Optimized process and Assessment of process modifications whenever it required Technology Transfer of Parenteral Dosage forms Technology Transfer at Zydus Neshar USA Technology Transfer among the Zydus Locations Review of site transfer dossier and developing site transfer products with/without Alternate vendor development activity and Gap analysis
- Trouble shooting and process improvement of regulatory products
- Instrumental in different initiatives at Zydus Viz, Prism, LRP, PACE
Manager (Pharmaceutical Technology Transfer)
Watson Pharma Limited
Goa
08.2006 - 07.2008
- Responsible for Technology transfer (Site Transfer) New Team created for Technology Transfer of site transfer products Responsible for All activities pertaining to Technology Transfer of products from US
- Coordination with Global pharmaceutical Technology department
- Planning for Technology Transfer from Watson US
- Responsible for Process Validation for Commercial Scale batches
- Bridge between Production and Transfer Site
- And Networking with QA, CQD, ADL and Regulatory affair
- Responsible for Execution of Pilot Scale and Exhibit Batches Documentation for Scale up batches
- After successful Stability study Planning / Execution for Commercial scale Validation Batches
- Documentation for Commercial scale validation batches.
Manager (Technology Transfer)
Ipca Laboratories Limited
Athal Silvassa
07.2004 - 08.2006
- Joined as Assistant Manager in Technology Transfer Dept
- New Team created for Technology Transfer of new products Promoted as Manager Technology Transfer in June 2005 Responsible for All activities pertaining to Technology Transfer
- Responsible for Execution of Pilot / Scale up Batches Documentation for Scale up batches
- After successful Stability study Planning / Execution for Commercial scale Validation Batches
- Documentation for Commercial scale validation batches
- As a part of production team Responsible for production activities.
Executive
Aventis Pharma Limited (Sanofi-Aventis Limited, Ankleshwar, Gujarat)
Ankleshwar
07.1996 - 06.2004
- Responsible for the Packaging activities in shifts
- Daily manpower handling and distribution of work for around 100 people
- Troubleshooting in packing machines viz
- Strip and Blister packing machines
- Packing material handling and reconciliation
- Monthly reporting
- As a multi-skill activity, transferred to manufacturing department from January 1999
- Responsible for manufacturing activities viz
- Wet and Dry Granulation, Compression, Coating
- Responsible for daily manpower distribution in manufacturing area
- Responsible for monthly reporting of products
- Implementation and maintenance of GMP requirements and training on the job training to subordinates and operatives
- Specialist in the Rulide formulation (Roxathromycin Tablets) Handled different tablet formulations such as Film coated, sugar coated tablets
- Participated in process and cleaning validations as a team member
- Project leader for Robust Process Technique for Lasilactone tablets.(Spironolactone and Frusemide Tablets) Material handling viz
- Requisition, transfer and reconciliation through SAP system Man-hours and Machine-hours reconciliation through SAP
- Implement and Maintain Global Quality Policies and Global EHS (Environmental, Health and Safety) Policies of the Company on the shop floor.
Trainee
Roussel India Limited
Thane
03.1996 - 07.1996
- Familiar with the activities in Injectable Department
- Responsible for the Inprocess Controls
- Daily Monitoring and Maintenance of Water for Injection Plant
- Participated in the Validation activities
- Manpower handling.
Education
Skills
- Team Capability Building
- Technology Transfer
- Statistical Process Control (Graphical Presentations of Statistical Data)
- Operations Management
- Manufacturing Process Improvements
- Product Development
- QMS handling
- Technical writing & Critical Thinking
- Expert in Strategic Priorities
- Process and product Troubleshooting
- Project Management
- Structured problem solving
- Leadership
- Regulatory Compliance
- Microsoft Office
- SAP (System, Application in Product)
- Statistical Process Control (Graphical Presentations of Statistical Data)
Affiliations
- Member of the Indian Pharmaceutical Association
- Member of the ISPE
Accomplishments
Successful Scale Up for Critical Products.
Experience of green field project from facility set-up, FDA approval and successful launch.
Personal Information
Date of Birth: 06/13/73
Family Details
Kranti Motipwar, Purvi Motipwar, Plaksha Motipwar
Languages Known
- English
- Hindi
- Marathi
- Gujarati
References
- Mr. S. L. Rajkondawar, Ex. President, Aventis Pharma Limited, Aventis house, Andheri
- Mr. P.B. Nair
Timeline
Vice President (Technical Services)
PAR Formulations (ENDO Inc.)
01.2020 - Current
General Manager Pharmaceutical Technology, Formulation & Development)
Zydus Healthcare Limited
07.2008 - 01.2020
Manager (Pharmaceutical Technology Transfer)
Watson Pharma Limited
08.2006 - 07.2008
Manager (Technology Transfer)
Ipca Laboratories Limited
07.2004 - 08.2006
Executive
Aventis Pharma Limited (Sanofi-Aventis Limited, Ankleshwar, Gujarat)
07.1996 - 06.2004
Trainee
Roussel India Limited
03.1996 - 07.1996
Similar Profiles
Shivam Shivaji GaikwadShivam Shivaji Gaikwad
Trainee Associate at Endo India Par FormulationTrainee Associate at Endo India Par Formulation
Ramesh JothibassRamesh Jothibass
Senior Analyst at Endo India Par Formulation Pvt LtdSenior Analyst at Endo India Par Formulation Pvt Ltd
Gangadhar MeherGangadhar Meher
Associate Director at Par Endo pharma Pvt. Ltd.Associate Director at Par Endo pharma Pvt. Ltd.
Pravin NadarPravin Nadar
Field Engineer at Agile ConncetsField Engineer at Agile Conncets
Sheetal Vijay SuryavanshiSheetal Vijay Suryavanshi
Accenture at Colud Operation AdminstratorAccenture at Colud Operation Adminstrator