Microsoft project
Jitendra Kumar Patra
Project Manager
Bangalore,KA
Summary
Results-driven project manager and scientist with 13 years of diverse experience in the pharmaceutical industry, specializing in project management and product development for regulatory markets. Proven expertise as a Technical Project Leader overseeing solid, liquid oral, parenteral, and ophthalmic dosage forms, complemented by strong managerial and analytical skills for effective team leadership. Skilled in planning, initiating, controlling, and executing comprehensive project management processes while delivering projects on time and within quality standards. Extensive experience in managing end-to-end projects for new chemical entities (NCEs), new drug applications (NDAs), and generic molecules, with a solid track record in formulation research and development aligned with organizational business goals.
Overview
13
13
years of professional experience
1
1
Certification
4
4
Languages
Work History
Project Manager
Syngene International Limited
05.2024 - Current
- Working as a Project Manager at Global program office, Syngene International Limited, since 6th May 2024 to till date. Managing end to end project of formulation development and analytical development.
Assistant Principal Scientist I (Manager I)
Brillpharma Pvt. Ltd. (Subsidiary of Bristol Laboratories Limited)
09.2019 - 05.2024
- Worked as an Assistant Principal Scientist I (Manager I) at Brillpharma Pvt. Ltd. (Subsidiary of Bristol Laboratories Limited) Since 19th Sep 2019 to 02nd May 2024 (About 5 years)
- Job Profile: As a Project manager: Managed end to end in-house development projects along with projects at CRO/CMO/CDMO. As formulation development team leader: Looking for inhouse development of generic product for Europe market.
Associate, Product Development
Jamp India Pharmaceutical Private Limited (Jamp Pharma Corporation, Canada)
06.2017 - 06.2019
- Worked as an Associate, Product Development, for Jamp India Pharmaceutical Private Limited (Jamp Pharma Corporation, Canada) from June 2nd 2017 to 26th June 2019 (2 years 1 month).
- Job Profile: Development Solid Oral Dosage Form for Canada, USA and Europe market. Managed a team size of 2 scientists in developments. Development of various pharmaceutical dosage forms (Immediate release/modified release tablets and coated pellets for delayed release products) for regulatory submission of US and Europe markets. Independent performance of pre-formulation studies, designing of formulation plans/strategies, execution of experiments, prototype declaration, optimization of trials, and document preparedness for technology transfer activities. Undertaking scale up batches, exhibit batches and product development. Manages project at Contract Research Organizations and Contract Manufacturing Organization relationship and communications as project leader (in-licensing).
- Self-motivated, with a strong sense of personal responsibility.
Sr. Research Associate, Product Development
Ipca Laboratories Limited
09.2016 - 05.2017
- Worked as a Sr. Research Associate, Product Development for Ipca Laboratories Limited, Mumbai from Sep 2016 to May 2017.
- Job Profile: Development Solid Oral Dosage Form for USA and Europe market. Development of various pharmaceutical dosage forms (Immediate release/modified release tablets and coated pellets for delayed release products) for regulatory submission of US and Europe markets. Independent performance of pre-formulation studies, designing of formulation plans/strategies, execution of experiments, prototype declaration, optimization of trials, and document preparedness for technology transfer activities. Undertaking scale up batches, exhibit batches and product development. Designs and undertakes quality scientific experimentation to develop robust solid oral dosage formulations and processes Using current approach like Quality by design (Qbd), Design of experiments (DOE), Risk assessments etc. Evaluation of Analytical results and troubleshooting for highly regulatory market like Canada, USA and Europe. Troubleshooting during development, discussion with cross-functionality team for smooth running of projects. Review of analytical reports and compilation of data for regulatory submission. Preparation of regulatory documents and response to queries to the regulatory bodies during drug approval process. Guiding subordinates during the development process.
Scientist I, Product Development
Enem Nostrum Remedies Private Limited
04.2015 - 09.2016
- Worked as a Scientist I, Product Development for Enem Nostrum Remedies Private Limited , Mumbai from Apr 2015 to Sep 2016
- Job Profile: Development Solid Oral Dosage Form for USA Development of various pharmaceutical dosage forms (Immediate release/modified release tablets and coated pellets for delayed release products) for regulatory submission of USA. Execution of Lab scale trial and scale up trials, Preparation of Tech transfer document, stability studies documents compilation of result and discussion for further trial and analysis of batch. Troubleshooting during development, discussion with cross-functionality team for smooth running of projects. Review of analytical reports and compilation of data for regulatory submission. Preparation of regulatory documents and response to queries to the regulatory bodies during drug approval process.
Research Associate, Formulation and Development
V-Ensure Pharma Technologies Private Limited
03.2014 - 04.2015
- Worked as a Research Associate, Formulation and Development for V-Ensure Pharma Technologies Private Limited, Mumbai from Mar 2014 to Apr 2015
- Job Profile: Development Solid Oral Dosage Form for USA/EU/CANADA Development of various pharmaceutical dosage forms (Immediate release/modified release tablets and coated pellets for delayed release products, Oral Suspension & emulsion, Emulsion for Injection) for regulatory submission. Execution of Lab scale trial and scale up trials, Preparation of Tech transfer document, stability studies documents compilation of result and discussion for further trial and analysis of batch. Troubleshooting during development, discussion with cross-functionality team for smooth running of projects. Review of analytical reports and compilation of data for regulatory submission. Preparation of regulatory documents and response to queries to the regulatory bodies during drug approval process.
Executive-R&D, Product Development
Medopharm Private Limited
04.2013 - 03.2014
- Worked as a Executive-R&D, Product Development for Medopharm Private Limited, Chennai from Apr 2013 to Mar 2014.
- Job Profile: Formulation and development of solid and liquid oral dosage form (Immediate release and modified release) for Domestic, ROW and EU market. Execution of Lab scale trial and scale up trials, Preparation of Tech transfer document, and stability studies documents compilation of result and discussion for further trial and analysis of batch.
Education
M.Pharma -
Utkal University
Odisha01.2012
B.Pharma - undefined
Utkal University
Odisha01.2010
D.Pharma - undefined
Orissa State Board of Pharmacy
Odisha01.2007
Skills
Working in integrated programs for Discovery and Development services for small and large molecules
Able to prioritize work and perform under pressure, Effective negotiation, and persuasion skills
Formulation and Development : Experience in formulation and development in US (ANDA), EUROPE & Canada
Worked on Solid dosage forms like Tablets: IR and MR; Capsules: IR and MR (Minitab and Pellets filled in capsule)
Worked in Multi Unit Particulate System (MUPS) technology Pellets compressed into tablet and filled capsule, Suspension and Emulsion
Worked on formulation development NCE molecules
Software
Certification
Project Management professional from project Management Institute in Oct 2024
Instrument Handled
Tablet Compression Machine (Cadmach, Sejong, Fette, Killian), Rapid Mixing Granulator, Fluid bed dryer, Fluidized Bed Processer (ACG, APCG) Autocoater Coater (Sejong, Ganson), Capsule Filling Machine, Blister Packaging Machine, Roll Compacter, Micro fluidizer, Oxygen analyzer, High performance homogenizer.
Timeline
Project Manager
Syngene International Limited
05.2024 - Current
Assistant Principal Scientist I (Manager I)
Brillpharma Pvt. Ltd. (Subsidiary of Bristol Laboratories Limited)
09.2019 - 05.2024
Associate, Product Development
Jamp India Pharmaceutical Private Limited (Jamp Pharma Corporation, Canada)
06.2017 - 06.2019
Sr. Research Associate, Product Development
Ipca Laboratories Limited
09.2016 - 05.2017
Scientist I, Product Development
Enem Nostrum Remedies Private Limited
04.2015 - 09.2016
Research Associate, Formulation and Development
V-Ensure Pharma Technologies Private Limited
03.2014 - 04.2015
Executive-R&D, Product Development
Medopharm Private Limited
04.2013 - 03.2014
B.Pharma - undefined
Utkal University
D.Pharma - undefined
Orissa State Board of Pharmacy
M.Pharma -
Utkal University