Jay Nirmal

Active professional with enthusiastic, ambitious and professional individual who has a proven record of accomplishment of achieving results in competitive environments. Capable and committed scientist having 17 years experience in industry who can enhance the performance of any industry with excellent organizational team management.

Assistant General Manager - Endoc Biotech Pvt. Ltd.

(2023-02)

Biotech company working in fermentation based API. Technical Head involved in broad range of activities.

• Product selection, development. Validation at lab scale and plant scale
• Plant design, QMS, Technology transfer, Plant Validation and DMF preparation of API
• Supply chain and Vendor qualification
• Active member in FDCA, GMP and WHO audit
• Mupirocin: Plant validation, WHO approval and CEP filing
• Mupirocin Calcium: Plant Validation
• Tacrolimus: Plant validation
• Fusidic acid: Plant validation
• Cyclosporine: Lab validation and pilot scale up

Asst. Manager - Intas Pharmaceuticals Limited

(2021-10 - 2023-02)

Involved in isolation of Tacrolimus crude and purification of crude.

• Literature survey and proposal of synthetic route/isolation for API
• Feasibility, optimization, validation and technology transfer of API
• Preparation or isolation, purification and characterization of impurity of API
• Preparation of Development report and Technology transfer document

Sr. Executive - Concord Biotech Limited

(2016-01 - 2021-09)

Biotech company working in semi synthesis and fermentation based API.

• Down streaming: DoxorubicinHCl, Amphotericin-B, Sirolimus
• Semi synthesis: Everolimus, Everolimus with 2% BHT, Everolimus premix, Biolimus, Doxorubicin HCl, Epirubicin HCl
• Literature survey and proposal of synthetic route/isolation for API
• Synthesis, development, optimization, validation and technology transfer of API
• Preparation or isolation and characterization of respected impurity of API
• Preparation of Technology transfer document

Entrepreneurship - Sigma Energy

(2012-01 - 2015-12)

Basic research division working on Chemicals and Nanotechnology.

• Development, optimization, validation and technology transfer of product as per customer's requirement
• Synthesis and isolation of metal, metal oxide and mixed metal oxide nanoparticle with organic compound capping
• Characterization of nanoparticle in terms of particle size, morphology and XRD
• Preparation of nano suspension in aqueous, polar and non-polar solvents for the solar cell and other relevant application

Research Scientist - Alembic Research Center

(2009-09 - 2011-12)

API Division.

• Handling of API projects, Scale up of R & D batches to commercial scale, Process Optimization, Characterization, Process development of products and Patent evaluation
• Vendors selection of Key Raw materials, Process validation and Commercialization, PDR & TTD preparation
• Coordinate with IPR, ADL and their team for development activity
• Technology transfer of DuloxetineHCl API
• Synthesis and development of Montelukast Sodium API and its respected impurities
• Literature survey, Synthesis, development and technology transfer of Dronedarone HCl API and its respected impurities

Junior Technical Supervisor - Cadila Pharmaceutical Ltd

(2004-04 - 2005-09)

API Division.

• Development of API and scale up activities
• Synthesis, development and technology transfer of Fexofenadine HCl API
• Synthesis of Carbetapentane tannate API
• Synthesis of Levetiracetam

R&D Chemist - Uma Laboratories Ltd.

(2003-07 - 2004-03)

Contract Research Organization.

• Synthesis of ethers and some heterocyclic moieties of drugs
• Synthesized many types of ethers with Williamson synthesis
• Handled successfully Milligram to Gram scale reactions

PhD - Heterocyclic synthesis - Sardar Patel University (2005-09)

Master of science - Organic chemistry - Sardar Patel University (2001-03 - 2003)

Bachelor of science - Pure chemistry - VP & RPTP Science college, Sardar Patel University (1998 - 2001)

H.S.C - Science stream - RPTP Science college (1996 - 1998)

S.S.C - C.P.Oza High school, Surendranagar (1996)