Harisathyan V
Manager – Manufacturing Science & Technology (MS&T)
Palakkad
Summary
Highly accomplished Professional with 19+ years in Solid Oral Dosages specializing in product transfer, scale-up/scale-down and process validations. Proven track record of successfully driving product launches and seamless transfer of manufacturing technologies for US, EU, & Canada markets. Expertise in product/process change controls, investigations, and market complaints. Subject Matter Expert for MS&T, Site Transfer, and Process-related Investigations. Authorized Technical Trainer, member of GEMBA & Internal Audit. Contributed to operational excellence initiatives
Overview
21
21
years of professional experience
4
4
years of post-secondary education
Work History
Manager - Manufacturing Science & Technology (MS&T)
Apotex Research Pvt. Ltd.
Bangalore
01.2017 - 10.2024
- Core competencies in new product launches, site technology transfer, product life cycle management, Process & Cleaning Validations, supply driven changes, process optimization/ Demonstration, Hold Time studies, Data trending, Stability Management, Annual Product Quality Review, Handling of Market Complaints, CAPA Management, Failure and Deviation Investigations, Quality Risk Management, Cross contamination Assessments and controls, Pre-formulation studies, Trouble shooting, Technical documentations
- Planning, organizing, and supervising the technology transfer of products from Formulation development to commercial production, Intra & Inter Site transfers,Site transfers to CMO's ensuring efficient prioritization and execution to meet product launch timelines.
- Collaborating with R&D, Quality, SCM, Project management and Manufacturing teams to facilitate the seamless transfer of solid oral dosage forms from development to production
- Developing and executing product transfer plans, including timelines, resources, and risk assessments
- Troubleshooting and resolving technical issues during the transfer process
- Designing, executing, and interpreting scale-up studies, ensuring process robustness and reproducibility
- Reviewing technical risks during product scale-up/scale-down prior to commercialization
- Identifying critical material attributes and process parameters, evaluating their effects on drug product critical quality attributes during the technology transfer process
- Evaluating the need for demonstration and optimization batches for new product launches and site transfer products based on regulatory requirements and technical risk assessments
- Overall execution & monitoring of the site technology transfer of products to/from the external locations (Within the organizations & CMOs).
- Conducting thorough reviews of technology transfer packages, raw materials, packing materials, and tooling required for technology transfer products.
- Ensuring seamless execution of process validation batches for new product launches and inter/intra-site transfer products and establishment of the commercial scale control strategy (Stage 2).
- Review/Approval of process validation protocols and reports, determination of validation sampling and testing requirements, troubleshooting as necessary to ensure timely completion.
- Monitoring of Stage 3A Continued Process Verification and interpretation of results by data trending using statistical tools like Minitab Software.
- Optimizing manufacturing processes to improve efficiency, yield, and quality.
- Identification of Critical process parameters, impact on Drug product CQA's and control strategies.
- Identification of critical quality attributes of drug product, describing design space and pre-formulation studies.
- Validation/Verification of Packaging process.
- Cleaning & process validation master plans review and establishment of life cycle management programs.
- Impact assessment on equipment and Utility qualification to determine the impact at system level.
- Maintaining accurate and up-to-date documentation for all transfer, scale-up, and validation activities
- Reviewing formulation development data, analytical data, and other requirements to ensure compliance during product transfer from development to commercial stages.
- Quality risk management process of new products through Technical risk evaluation and Technical Risk assessment using basic, intermediate and formal tools.
- Providing technical direction and support for troubleshooting manufacturing documents and processes, resolving issues using scientific concepts and principles.
- Establishing hold time studies for intermediate and semi finished products.
- Stability management as per commercial stability program and ICH guidelines.
- Review/Approval of Annual Product Quality Review reports of commercially marketed products
- Data trending of drug substances, intermediate/in-process and semi-finished bulk products.
- Review of market complaints and involvement in critical complaint investigation.
- Generating and revising various documents such as SOPs, formats, protocols, reports, and master formulas
- Coordinating with departments including manufacturing, packaging, formulation development, warehouse, and QA validation on materials, batch records, technical processing issues, and equipment failures
- Organizing and facilitating project steering/technical project meetings with cross-functional teams
- Managing deviations, change controls, and addressed regulatory queries related to filed products
- Investigation of Product/process related failure and/or deviations using data collection/root cause analysis tools and techniques, Corrective and Preventive action management.
- Ensuring Right First Time (RFT) documentation.
- Identifying, developing, and approving new vendors for APIs and excipient (Alternate Vendor Development) as part of cost-effectiveness program
- Authorized technical trainer conducting awareness and technical trainings on new and legacy products for cross-functional departments
- Professional understanding of ICH, SUPAC, ISPE, and other regulatory guidelines
- Subject Matter Expert for MS&T, Site Transfer, and Process-related Investigations
- Member of GEMBA & Internal Audit.
- Tracking project progress daily, conducting regular follow-ups with relevant teams to achieve organizational goals
Assistant Manager - Formulation Technology Transfe
Torrent Pharmaceuticals Ltd.
Ahmedabad
10.2014 - 01.2017
Senior Research Scientist – PDL
Ranbaxy Laboratories Limited
Mohali
08.2012 - 12.2012
Senior Scientist [Manager] – F&D (PTC)
Zydus Cadila Health Care Limited
Ahmedabad
05.2011 - 03.2012
Senior Scientist – Technology Transfer
Actavis Pharma Manufacturing Pvt. Ltd.
Chennai
04.2008 - 05.2011
Assistant Manager–Formulation Technology Transfer
Dr. Reddy’s Laboratories Limited
Hyderabad
08.2006 - 04.2008
Executive- Quality Assurance
Biological E Limited
Hyderabad
12.2005 - 08.2006
Executive- Quality Assurance
Sanofi –Aventis Pharma Limited
Goa
02.2005 - 12.2005
Quality Assurance Officer
Cipla – Nebumed Pharma Pvt. Ltd.
Goa
05.2003 - 02.2005
Education
Master of Business Administration (MBA) - Quality Management
Birla Institute of Technology & Science
Pilani, India 06.2022 - 05.2024
Master of Pharmacy (M.Pharm) - Pharmaceutics/Industrial Pharmacy
Rajiv Gandhi University of Health Sciences
Bangalore, Mangalore 03.2001 - 03.2003
Skills
- Critical thinking and problem solving
- Leadership and Teamwork
- Ability to Multitask
- Effective Time Management
- Subject Matter Expert
Timeline
Master of Business Administration (MBA) - Quality Management
Birla Institute of Technology & Science
06.2022 - 05.2024
Manager - Manufacturing Science & Technology (MS&T)
Apotex Research Pvt. Ltd.
01.2017 - 10.2024
Assistant Manager - Formulation Technology Transfe
Torrent Pharmaceuticals Ltd.
10.2014 - 01.2017
Senior Research Scientist – PDL
Ranbaxy Laboratories Limited
08.2012 - 12.2012
Senior Scientist [Manager] – F&D (PTC)
Zydus Cadila Health Care Limited
05.2011 - 03.2012
Senior Scientist – Technology Transfer
Actavis Pharma Manufacturing Pvt. Ltd.
04.2008 - 05.2011
Assistant Manager–Formulation Technology Transfer
Dr. Reddy’s Laboratories Limited
08.2006 - 04.2008
Executive- Quality Assurance
Biological E Limited
12.2005 - 08.2006
Executive- Quality Assurance
Sanofi –Aventis Pharma Limited
02.2005 - 12.2005
Quality Assurance Officer
Cipla – Nebumed Pharma Pvt. Ltd.
05.2003 - 02.2005
Master of Pharmacy (M.Pharm) - Pharmaceutics/Industrial Pharmacy
Rajiv Gandhi University of Health Sciences
03.2001 - 03.2003
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