General Manager in R&D at Apothecon Pharmaceuticals Pvt. Ltd. (2016-06 – Present)
Pharma professional with 23 year's rich experience in Research & Development of generic APIs with cost effectiveness and eco-friendly process.
- Responsible for API Research and Development activities to in-line with business and regulatory requirements with the team of 55 synthesis Scientist and 40 analytical scientists.
- Leading the Research & development department for process development of generic APIs like Heterocyclic products, polymer products, iron-based products and oncology products at lab level and after their scale-up and commercialization along with Regulatory and ICH requirements
- Successfully Developed about 50 generic products along with 14 patents filed for novel research
- Versatile knowledge of polymorphism screening studies
- Expert in impurity synthesis like critical impurities, process impurities, degradation impurities, nitrosamines impurities, genotoxic impurities, etc.
- Initiate the peptide molecule synthesis using solid state chemistry amino acids binding on resin.
- Strong in Selection of Right products for development and commercialization for growth of company
- Handling of IPR and Literature search for effective process development
- Having good knowledge in analytical and Interpretating the reports of HPLC, GC, LC-MS, GC-MS, 1H NMR, 13C NMR, 2D NMR, XRPD, PSD Histogram, FTIR spectra, DSC, TGA, etc.
- Supported to file 40 DMF and among them 25 DMF are approved.
- Involved in the major regulatory audits and successfully completed the audits like USFDA, UK MHRA, EU (Austria), ANVISA (Brazil), TGA (Australia), Russia, Saudi Arabia, Korea, Turkey.
- Actively participated in worldwide CPHI and many business meet to promote the products in terms of business.
- Evaluating the IMS data market evaluation for product selection and quick delivery of product to get the right business in right time.
- Contribute to company growth by excellent work done in some important projects like Miglustate, Maraviroc, Crizotinib, Triheptanoin and Salcaprozate sodium so credential given by organization.
- Effective Man power handling
- Developing the products timely with proper control in process
- Interaction with management for new products and business strategies
- Guiding R&D synthesis, Impurity section, IPR section, Analytical section, Polymorph section
- Leading the IPR team for patent evaluation to file patent for novel work and make strategy to by-pass granted patent
- Developed and implemented a comprehensive R & D Strategy aligned with company goals, driving significant advancements in niche products development like Miglustate, Carglumic acid, Trientine hydrochloride, Anagrelide etc.
- Focus on development of economical viable product with process safety and environment safe.
- Control of impurities during process based on Maximum daily dose (MDD)
- Defining the In-house specification as per ICH and regulatory requirements
- Complex products development initiate by reverse engineering of innovator product and completed with sameness study results are exactly matched with RLD.
- Involves in new molecule selection process for development by market evaluation, study the patent expiry of molecules, product volume & price, IMS data evaluation and number of competitors.
- Contribution in company business development activities by attending international business meet CPHI to provide technical inputs and prove how company products/technology better than others to promote the company products to customers/clients.
- Response to Customer technical and IPR related queries
- Develop and implement a successful strategy to deliver DMFs / CEPs to regulatory agencies.
- Leading the dedicated team for DMF deficiency response and to submit response intime to regulatory agency.
- Involving the monthly review meeting of work progress
- Providing technical support to cross functional team like manufacturing, QA, RA and QC.
- Successfully managed R&D budget, prioritizing projects based on market needs and potential impact.
- Create and sustain a company culture with the highest ethical and scientific standards and teamwork to achieve R&D objectives.
Assistant Manager at TEVA API India Ltd. (2009-10-26 – 2016-05-30)
Research and development of Generic API
Research Scientist at Jubilant Chemsys Ltd. (2007-10-19 – 2009-10-09)
Research and development of CRO projects.
Senior Research Associate at Oxygen Healthcare Research Pvt ltd (2006-04-24 – 2007-10-01)
Research and development of CRO projects.
Research Assistant at Sun Pharma Advance Research Centre (2001-08-06 – 2002-12-14)
Research and development of API projects
