AMIT JAIN
Summary
- To work in an organisation where innovation and excellence is the way of life, where my full potential will be explored and where I will get ample scope of development and growth. CAREER ABTRACT
- Four products listed in orange book. (Four products approved in US market)
- Four products commercialised in EU market
- Successfully submitted Para IV ANDAs.
- Master of Pharmacy in Pharmaceutics with more than 15 years of experience in Formulation Development in Pharmaceutical R&D
- NCE (New Chemical entity) projects exposure
- Management of team, leading to timely delivery of projects with a position of team leader
- Experience in QbD based formulation development approach of solid oral dosage forms for regulated market
- Actively involved in Technology transfer
- Client based (CDMO) project handled and completed successfully.
- Perusing doctorate degree
Overview
16
16
years of professional experience
Work History
Sr. Research Scientist
Piramal Pharma
Ahmedabad
05.2016 - Current
Sr. Research Fellow
Emcure Pharmaceutical
Ahmadabad, Gujarat
01.2011 - 05.2016
Scientist II
Torrent Research Centre
Ahmedabad, Gujarat
12.2008 - 12.2010
Research Associate
Ajanta Pharma
Mumbai
12.2007 - 12.2008
Trainee
Alkem Research Centre Panvel
Mumbai
04.2007 - 11.2007
- Total year of experience ≈ 15 years 1 months
- JOB PROFIE
- Preparation of formulation development strategy for client and generic projects, its execution and tech transfer (virtually and with physical presence)
- Leading team of formulation development scientists and manage the day-to-day operations of R&D by providing guidance, encouraging, teamwork, and facilitating related professional work processes to achieve high performance standards
- Ensuring consistent on-job trainings during project experimentations and reviews
- Leading project related teleconferences with clients on technical
- Literature review including stability indicating method, PAR, biophama review, patents & its examples, research articles etc
- Maintain relationship with customers, understand their needs and create pipeline projects for customer based on marketing inputs; identify new applications, new opportunities and customer pain areas for value selling
- Documents review including Product Development Report, IID report, TDP, size and shape report, batch protocols, specifications, sampling plans, MFC, BMR’s, BPR’s, stability protocols and other relevant documents for regulatory filing purpose for good technical writing and adequacy
- Performance review (half yearly / annually) of team members
- Coordination and integration with all on-site / off-site functions toward on-time delivery of the projects
- Supporting leadership in various organizational / site initiatives
- Ensuring strong integration of team members with cross-functions for on-time project deliverables
- Ensure compliance and awareness of data integrity at functional area and site
- Follow GMP, GDP practices for all processes and train the subordinates to follow the same
- Involvement in trouble shooting
- Coordinate with RA for filing ANDAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely manner for ANDA filings
- To be a part of the internal audit team
- Conduct audit prepare an audit report and follow up for CAPA
- PROJECTS
- Combination product with high sensitivity to hydrolysis
- Potent API with complete bio waiver
- Oral iron chelator Tablet
- Tablet containing steroidal antimineralocorticoid of the spirolactone group
- Tablets used in Huntington Disease
- Pellets used in treatment of Crohn’s Disease
- Bilayer tablets fixed dose combination of Antihypertensive drugs
- NCE molecules
- Critical three API combination product delivered successfully
- Projects done including bilayer tablets, sustained release tablets, immediate release tablets and fixed dose combination tablets
- Worked on projects including Enteric coated tablet for the treatment of ulcerative colitis
- Injection as well
- Got hands on experience in Pellets technology and MUPS technology
- STRENGTHS
- Fast track development in scientific way
- Management of formulation team for facilitating the activities related to projects
- Improvising existing formulations, development and trouble-shooting
- Management of diversified activities in development cycle of product
Education
M. Pharmacy - undefined
TN Dr MGR Medical University
B. Pharmacy - undefined
SGSPS Institute of Pharmacy
Skills
Mailing Addressundefined
Timeline
Sr. Research Scientist
Piramal Pharma
05.2016 - Current
Sr. Research Fellow
Emcure Pharmaceutical
01.2011 - 05.2016
Scientist II
Torrent Research Centre
12.2008 - 12.2010
Research Associate
Ajanta Pharma
12.2007 - 12.2008
Trainee
Alkem Research Centre Panvel
04.2007 - 11.2007
M. Pharmacy - undefined
TN Dr MGR Medical University
B. Pharmacy - undefined
SGSPS Institute of Pharmacy
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