Jivan Kharat
Scientist I @ Teva Pharmaceuticals | Formulation Development, Master of Pharmacy (Pharmaceutics)
- Role
- Scientist i at Teva Pharmaceuticals
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Jivan Kharat
Experienced Scientist with a demonstrated history of working in the pharmaceuticals…
Experience
Scientist i
Jan 2022 — Present · US
Carry out design and development of oral solid dosage forms through Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) filing and/or product launch.• Develop and execute formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinate studies with other technical groups (Analytical Sciences, Legal and Regulatory & Pharma Tech).• Maintain a high level of expertise within the field and develop new technologies and concepts to be applied in the development of oral controlled release drug products.• Identify, analyze, and suggest corrective actions to optimize R&D processes, technology, and regulatory compliance issues.• Design experimental plan; perform pre-formulation, formulation development work on oral controlled/extended release and immediate release dosage forms.• Generate and review analytical data to support the product development work.• Write protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for ANDA submissions to regulatory agency.• Plan appropriate analytical testing and stability studies on pivotal batches.• Perform appropriate documentation and prepare pharmaceutical product development report (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDAs.• Survey the scientific literature and perform patent search to remain current with recent developments in generic pharmaceutical research and regulatory arena and novel drug delivery systems.• Plan bioequivalence studies on drug product and evaluate the bioequivalence data to recommend changes in formulation, if needed.• Provide scientific and technical directions to junior staff members (Scientists, Technicians & Operators) to ensure project deadlines and performance standards are met.
Skills
- Regulatory Affairs
- Formulation
- Pharmaceutical Industry
- Sop
- Pharma Profrssionals: Formulation R & D, Product Development and Anda Submission
- Pharmaceutics
- Good Laboratory Practice (Glp)
- Quality by Design
- Gmp
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