SWAPNIL KASTURE
Senior Manager, R & D Dept.
Nashik,Maharashtra
Summary
Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
13
13
years of professional experience
5
5
Certifications
Work History
Senior Manager
Hexagon Nutrition Limited
12.2020 - Current
- Led development activities for clinical nutrition, premix products, and ready-to-use products as per UNICEF guidelines for domestic and export markets
- Planned and executed developmental, scale-up, process optimization, submission, and validation batches of developed products
- Assisted in preparing regulatory documents, including statements of ingredients as per FSSAI, FSSAI filing documentation, Bill of Material, Master Formula Record, Process Optimization Protocol, Process Optimization Report, Hold Time Study Protocol, Stability Protocol, Product Development Report, SOPs, and guidelines
- Prepared, monitored, and compiled stability studies as per ICH guidelines
- Initiated change control and new product initiation forms for new product manufacturing
- Implemented new formulation processes for quality improvement and cost reduction
- Troubleshot and improved the quality of existing products
- Discussed product improvement with suppliers and aimed to reduce formulation costs
- Ensured overall vendor development activities and approval
- Facilitated smooth product transfer and new product launches for commercial lots, ensuring compliance with current GMP guidelines
- Regularly updated current regulatory requirements and revised documents accordingly
- Coordinated with internal departments like Purchase, Analytical R&D, Production, Quality Control, Regulatory Affairs, Quality Assurance, and Packaging for seamless product development and execution
- Maintained good knowledge of FSSAI regulations
- Led a team of 4-6 members
- Conducted training sessions for team members on new processes, technologies, and compliance requirements
- Developed stable and robust packaging materials like cartons, laminates, sachets, Alu, MET PET pouches, and shippers as per product requirements
- Presented complex scientific data and research findings clearly and effectively to stakeholders, including senior management, regulatory bodies, and potential investors
- Regularly updated cross-functional teams on project progress, challenges, and milestones
- Facilitated collaboration between different departments, such as marketing, manufacturing, and quality assurance
- Analyzed market trends and consumer needs to guide product development
- Collaborated with marketing teams to align product development with market demands
- Conducted product cost analysis and developed pricing strategies
- Presented new ideas and strategic plans to drive innovation and improve product development processes.
Senior Scientist
Alkem Laboratories Limited
09.2015 - 12.2020
- Worked on various projects including Solid (Tablets, Capsules, Granules), Liquid (Syrup, Suspension, Emulsion, Drops), Semisolid (Gel, Cream, Lotion), Parenterals (Large and Small Volume), and Ophthalmic preparations for the domestic market
- Planned and executed developmental, scale-up, process optimization, submission, and validation batches for developed products and contract manufacturing (Third party), Loan license products
- Assisted in preparing various regulatory documents such as Test license applications, NOC documents for non-approved DCG(I) drugs, draft manufacturing licenses, API consumption plans, DCG(I)/FSSAI filing documentation, Bill of materials, Master formula records, Process optimization protocols and reports, Hold time study protocols, Stability protocols, Product development reports, SOPs, and guidelines covering product development activities and equipment
- Initiated change control and new product initiation forms for new product manufacturing
- Prepared, monitored, and compiled stability studies as per ICH guidelines
- Addressed troubleshooting and quality improvement of existing products
- Engaged with suppliers for product improvement and cost reduction
- Implemented new formulation processes for quality improvement and cost reduction
- Ensured smooth product transfer and new product launch for commercial lots, adhering to current GMP guidelines
- Planned and executed routine and developmental activities as per project requirements
- Possessed good knowledge of DCG(I) and FSSAI filing.
Scientist
Ipca Laboratory Limited
11.2013 - 09.2015
- Conduct literature surveys for product development using patents, Orange Book, PDR, leaflets, etc
- Procure and characterize innovator/competitor samples
- Identify and qualify vendors for excipient and API
- Perform preformulation studies
- Develop various dosage forms (Tablet, Liquid, Capsule, Injection, Topical Gel) for domestic and ROW markets
- Facilitate technology transfer
- Troubleshoot issues with suspensions, conventional tablets, and bilayer tablets
- Prepare documents such as Finished Product Specifications, Bill of Materials, Master Formula Records, Product Development Records, Stability Protocols, and Validation Protocols
- Prepare periodic reports on ongoing projects
- Develop Standard Operating Procedures (SOPs)
- Handle instruments such as Fluidized Bed Processor, Osmometer, Bilayer Tablet Compression Machine, Brookfield Viscometer, Rapid Mixture Granulator, Fluidized Bed Dryer, and Single Tablet Compression Machine
- Perform and evaluate stability data as per ICH guidelines.
Research Associate
Ajanta Pharma Limited
11.2012 - 11.2013
- Developed & commercialized ophthalmic preparations for the domestic market
- Characterized innovator and competitor samples
- Managed vendor development and approval processes
- Prepared documents such as finished product specifications and master formula records
- Operated and maintained equipment including osmometers, pH meters, and filtration assemblies
- Evaluated stability data as per ICH guidelines.
Officer
Encore Healthcare Pvt. Ltd.
02.2011 - 11.2013
- Developed tablets, capsules, and liquid formulations for the domestic market
- Conducted literature surveys to support product development
- Prepared comprehensive documents for product development and validation
- Coordinated with the Regulatory Department for dossier compilation
- Validated processes for developed products to ensure quality and compliance
- Operated and maintained various instruments including RMG, FBD, Ball Mill, Tablet Machine (10 & 12 station), and Conventional Coating Pan
- Identified and resolved issues in existing products
- Implemented cost-reduction strategies to improve efficiency
- Evaluated stability data as per ICH guidelines
- Designed artwork for tablets, capsules, and liquid products.
Education
Master of Pharmacy (Pharmaceutics) -
M.G.V.'s College of Pharmacy
Nashik, MaharashtraBachelor of Pharmacy -
Shri. Bhagwan College of Pharmacy
Aurangabad, MaharashtraHSC - undefined
Pune Board
Pune, MaharashtraSSC - undefined
Pune Board
Pune, MaharashtraSkills
Documentation And Reporting
Certification
4-Months certificate course on Understanding Food Regulations of India by FSSAI
Accomplishments
- Successfully launched a low glycemic index clinical nutrition protein supplement for diabetes patient
- Introduced a new segment of NUTRON products tailored for diverse groups including men, women, the elderly, gym-goers, athletes, and health professionals
- Successfully performed IQ, PQ, and OQ of equipment for ready-to-use products, along with validating the manufacturing procedure
- Organized the 10th International Yoga Day event for employees
- Team of the Quarter for formulating orodispersible tablets of the Amisulpride molecule
- Best Performer for successfully launching 8 small volume parenteral products in a single quarter
Languages
Marathi
Hindi
English
Hobbies: Practicing Yoga, Trekking, Playing Cricket, Plogging & Dancing
- Practicing Yoga: Enhances flexibility, reduces stress, and improves overall well-being.
- Trekking: Boosts cardiovascular health, mental clarity, and fitness.
- Playing Cricket: Improves stamina, coordination, and teamwork skills.
- Plogging: Combines exercise with environmental cleanup, promoting fitness and mindfulness.
- Dancing: Refreshes mood.
Disclaimer
I hereby solemnly do affirm that the particulars furnished above are true to the best of my knowledge.
Work Preference
Work Type
Full TimeWork Location
HybridImportant To Me
Company CultureWork-life balanceCareer advancementPaid sick leaveHealthcare benefitsTeam Building / Company RetreatsFlexible work hoursPersonal development programsWork from home optionTimeline
Senior Manager
Hexagon Nutrition Limited
12.2020 - Current
Senior Scientist
Alkem Laboratories Limited
09.2015 - 12.2020
Scientist
Ipca Laboratory Limited
11.2013 - 09.2015
Research Associate
Ajanta Pharma Limited
11.2012 - 11.2013
Officer
Encore Healthcare Pvt. Ltd.
02.2011 - 11.2013
Master of Pharmacy (Pharmaceutics) -
M.G.V.'s College of Pharmacy
Bachelor of Pharmacy -
Shri. Bhagwan College of Pharmacy
HSC - undefined
Pune Board
SSC - undefined
Pune Board
4-Months certificate course on Understanding Food Regulations of India by FSSAI
Food Safety Supervisor
Advance Manufacturing & COVID
NPD & Commercialization in Industry by Centurion University
Product Safety Management System Certification FSSC 22000 Version 6.0
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