Nishant Naware
Dayton,New Jersey
Summary
Excellent hands-on 20 years of experience in formulation and process development playing critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development. Hands on experience of Pre-formulation studies, formulation and process development, optimization, scale-up and manufacturing of ANDAs and NDA (505b2), Tech transfer and Process Validation of Solid and Liquid oral. Motivating leader with history of building and managing formulation teams. Effective communication skills. Proficient at identifying formulation and process issues and bring technical solutions to achieve the robust, cost-effective and bio-equivalence product. Collaborate effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
21
21
years of professional experience
Work History
Associate Director, R&D
i3 Pharmaceuticals
Warminster, PA
01.2022 - Current
- Lead the team Formulation Scientists, Analytical Scientist & Technicians
- Serving as a critical R&D member and leader of the projects responsible for planning and developing multiple projects
- Provided leadership for numerous product development projects from scale-up and transfer of process technology to manufacturing
- Communicating and coordination with various departments like the IP team, Marketing team, Regulatory team, ADL, QA/QC, and production for efficient & timely execution of the projects
- Preparation, review, and approval of technical reports like BMR, BPR, Protocols, PDR, QBR
- Actively participated in FDA audits
- Managing the product development activities related to formulation/transfer with external BD partners (incl
- CMOs, CROs,CDMOs).
- Created and updated physical records and digital files to maintain current, accurate, and compliant documentation.
Group Leader/ Principal Scientist, R&D (Solid/Liquid Orals)
MSN Pharmaceuticals
02.2020 - 12.2021
- Team lead of Formulation Scientists & Technicians
- Communicating with the India team for Project transfer and updates
- Serving as a critical R&D member and leader of the projects responsible for planning and developing multiple projects related to solid & Liquid oral dosage generic drug products
- Accountable for process optimization and scale-up activities, design space definition and technology transfer to commercial plant
- Execution of Scale up, Exhibit, and Process validation batches
- Review of ANDA batches stability data and until approval and post approval
- Regulatory support until ANDA approval and preparation response to FDA queries
- Review of R&D projects, Exhibit batches specifications, SOPs, Incidents, planned deviations, CGMP documentation, change controls, CAPA
- Finalization tablet tool drawings and ordering and procurement
- Provide technical support for trouble shooting of existing commercial products
- Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ)
- Communicating and coordination with various departments like the IP team, Marketing team, Regulatory team, ADL, QA/QC, and production for efficient & timely execution of the projects
- Preparation, review, and approval of technical reports like BMR, BPR, Protocols, PDR, QBR
- Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ)
- Actively participated in FDA audits.
Manager, R&D (Orals)
Aurobindo Pharma
07.2013 - 01.2020
- Team leads of 2 Formulation Scientists & 2 Technicians
- Responsible for planning and developing multiple projects, setting development/ANDA filing goal
- Provided leadership for numerous product development projects from scale-up and transfer of process technology to manufacturing
- Product development activities related to formulation/transfer with external BD partners (incl
- CMOs, CDMOs)
- Interfaced regularly with Regulatory, Project Management, Technical Service, Bioequivalence and Quality Management team
- Communicating and coordinating with various departments like the IP/Marketing/Regulatory team, ADL, QA/QC, and production for efficient & timely execution of the projects
- Preparation, review, and approval of technical reports like BMR, BPR, Protocols, PDR, QBR
- Actively participate in FDA audits
- Review of ANDA batches stability data and until approval and post approval
- Regulatory support until ANDA approval and preparation response to FDA queries
- Review of R&D projects, Exhibit batches specifications, SOPs, Incidents, planned deviations, CGMP documentation, change controls, CAPA.
Scientist IV (Manager)
Aurobindo Pharmaceutical LTD.
09.2007 - 07.2013
- Team lead of Formulation Scientists, Analytical Scientist & Technicians
- Entrusted with the responsibility of the development of critical projects and transfer to production
- Working on solid dosage forms like Immediate Release Tablets, Capsules, and Powder for Oral suspension, etc
- And handling projects for regulated markets for ANDA/Generic filing an NDA filing mainly in USA & Europe
- Assigned responsibility for creating, conducting, and evaluating the stability programs as per ICH guidelines supporting the product development process
- Monitoring, preparation and implementation of scale-up processes, stability protocols, and development reports
- Ensuring timely and correctly preparation of all technical documents like BMR, Sampling Protocols & Product development report & technology transfer documents, analytical validation report, etc
- Communicating and coordinating with various departments like ADL, QA/QC, and production for efficient & timely execution
- Communicating with the US team for Project transfer and updates.
Research Associate (Assistant Manager)
Torrent Pharmaceuticals LTD.
07.2004 - 09.2007
- Team lead of Formulation Scientists
- Created, conducted, and evaluated the stability programs as per ICH guidelines supporting the product development process
- Developed non-infringing products for the domestic market
- Involved in the development of critical projects and transferring to production
- Communication and coordination with the vendors and suppliers for desired quality excipients for the timely execution of the projects
- Searched and reviewed Patents for product development
- Involved in the preparation and implementation of scale-up processes & reports, stability protocols, and development reports.
Associate Pharmacist
U.S.V. LTD.
12.2003 - 07.2004
- Involved in the troubleshooting of existing products and successful transfer to production scale.
R&D Officer, Production Officer
Drug Delivery System (CIPLA)
12.2002 - 12.2003
- Developed Syrup and Suspension and worked on conventional tablets like Uncoated & Film-coated tablets, Enteric-coated tablets/Sustained Release tablets and liquid orals like Syrups and Ready to use Suspension (Oil-based) etc
- Involved in the optimization of process & preparation and implementation of scale-up Processes
- Responsible for coordinating between various departments like QA/QC, production for efficient and timely execution of the projects
- Involved in the preparation of all technical documents like BMR, Sampling Protocols & technology transfer documents.
Education
Master Degree in Pharmaceutical and Medicinal Chemistry -
S.G.S.I.T.S. Indore
01.2000
Skills
- Pharmaceutical Product Development
- Product Development
- Dosage form developed/Methods
- Process Development
- Quality Compliance
- Documentation
- Regulatory
- Patents
- Strategic Planning
- Team Collaboration and Leadership
- Critical Thinking
- Resources Allocation
Timeline
Associate Director, R&D
i3 Pharmaceuticals
01.2022 - Current
Group Leader/ Principal Scientist, R&D (Solid/Liquid Orals)
MSN Pharmaceuticals
02.2020 - 12.2021
Manager, R&D (Orals)
Aurobindo Pharma
07.2013 - 01.2020
Scientist IV (Manager)
Aurobindo Pharmaceutical LTD.
09.2007 - 07.2013
Research Associate (Assistant Manager)
Torrent Pharmaceuticals LTD.
07.2004 - 09.2007
Associate Pharmacist
U.S.V. LTD.
12.2003 - 07.2004
R&D Officer, Production Officer
Drug Delivery System (CIPLA)
12.2002 - 12.2003
Master Degree in Pharmaceutical and Medicinal Chemistry -
S.G.S.I.T.S. Indore