Nitin Jain
Faridabad
Summary
- Seeking professional level assignments in project management with an organization of repute where my experience, knowledge and skills are effectively and continuously nourished by challenges and to imperatively search for avenues which offers me with opportunities to evolve as an efficient professional.
- Professional with 15 years of work experience in the pharmaceutical industry in multiple functions like Project and New Product Launches & Site Transfers, R&D Processes. Seasoned project management specialist with comprehensive experience in leading projects from inception to completion. Skilled in coordinating cross-functional teams, optimizing processes for efficiency, and implementing innovative solutions to complex challenges. Proven ability to deliver projects on time and within budget while maintaining high standards of quality. Demonstrated success in enhancing operational workflows and significantly improving project outcomes through strategic planning and effective communication.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Sr. Project Manager
Aspire Pharmaceutical Limited
01.2020 - Current
- Company Overview: Aspire Pharmaceutical Limited (formerly known as Morningside Healthcare Ltd) is a UK pharmaceutical company specializing in licensing and supplying generic medicines, primarily in the UK/EU and emerging third-world nations.
- A key member of the operations team has been responsible for planning and execution of new launches in the UK/EU once the MA is received, and also for taking care of successful site transfers in the interest of business for existing molecules that are being manufactured in India or in the UK/EU.
- I have also been responsible for the successful initiation and completion of launches of molecules that are in-licensed or out-licensed in tie-ups with business partners based in Europe and the Nordic region.
- Also taking care of new product development (NPDs) in coordination with CRO partners in India and in the UK/EU for filing with the UK MHRA.
- CRO/CMO selection and scope finalization: Finalization and awarding of the project to the CRO/CMO based on the pre-assessment done at the initial level, checking on product feasibility based on the equipment train available at the CRO/CMO site, cost negotiations, and finalization of scope and other agreements.
- Project Planning and Initiation: Creation and updating of project plans clearly defining timelines, or target completion schedules, for individual activities.
- Project Execution and Monitoring: Mapping project progress at the CRO/CMO level with respect to pre-defined project plans for individual stage gates.
- Project Communication: Sharing project updates on a weekly or fortnightly basis with Higher Management, which involves following up on the escalation matrix regarding delays or issues that potentially have a severe impact on project deadlines, followed by an assessment of the risk involved and its mitigation measures.
- Scheduling a discussion inviting various stakeholders internally or externally, to track project progress and discuss any roadblocks or technical challenges/issues faced.
- Project Closure: Reporting on good contributions as well as shortcomings that have occurred during the life cycle of the project as part of lessons learned for future projects.
- Regularly have updates with post-product launch information, including marketing, sales trends, regulatory information, etc., for new launches.
- Monthly review meetings with the formulation head and the analytical development team for internal project status and strategy planning for regulatory filing in the case of NPDs.
- Facilitating with CFTs internally and CRO partners externally to finalize responses to RFI's queries received from the agencies in reference to the filed dossiers.
- Notable Contribution: Last year, from January 2024 until December 2024, had been exceptionally well, as we were able to achieve product launches worth £5.8 million in the UK/EU, with successful new product launches for 25 products (43 SKUs). Also, we were able to file dossiers with the UK MHRA for eight generic molecules.
ASSISTANT MANAGER
TORRENT PHARMACEUTICAL LIMITED
08.2016 - 12.2019
- Defining scope of the project, project planning & scheduling, procurement, executing and monitoring through the project cycle
- Creation of project plan (trackers) document in coordination with functional groups
- Coordinating with multifunctional teams including Business Development, Marketing, Finance, Procurement, ADL, FnD, Quality, QA, QC, Planning, SCM, Production, Supply Chain, RA, Clinical so as to ensure timely delivery of project as per the schedule OR to identify and flag out events/issues if any which could potentially impact the scheduled project timelines
- Tracking & monitoring of the projects and update the project plan documents on regular basis by conducting weekly, monthly and quarterly review meetings
- Responsible for arranging timely response to regulatory deficiencies/queries received for products to be filled in regulated market
- Conducting daily meetings with various CFT heads to discuss project updates and ensure timely delivery of project as per the schedule OR to identify and flag out events/issues if any which could potentially impact the scheduled project timelines
- Responsible for arranging timely response to regulatory deficiencies/queries received for products to be filled in US/EU/CA/AU/SA market
- Notable Contribution: From Sept'17 till Mar'19, successfully managed to develop & execute 8 First to File (FTFs) products for which the dossiers were successfully submitted to USFDA
- Approvals are awaited
- Also managed to execute 10 Non FTFs products which were submitted to USFDA by Apr'18
ASSISTANT MANAGER
IPCA LABORATORIES LIMITED
Mumbai
06.2014 - 08.2016
- Planning, execution and finalizing projects within constraints of on time delivery and scope objectives, including acquiring resources and coordinating efforts of team members in order to deliver projects according to plan
- Identifying, effectively communicating and resolving project issues and risks
- Developing risk management plans
- Effectively communicating project status to project stakeholders amongst cross functional teams (CFTs)
- Notable Contribution: Successfully managed 20 Exhibit batches for EU & US market driven products in FY'15-16
EXECUTIVE OFFICER
INCEPTA VACCINE LIMITED
Dhaka
02.2012 - 01.2014
- Company Overview: Incepta Vaccine Limited (part of Incepta Pharmaceutical Limited, Bangladesh's second largest pharmaceutical group) is the first human Vaccine manufacturing unit in Bangladesh
- Led a team of 3 research scientists working on the development of bacterial human vaccines against Typhoid, Streptococcus Pneumoniae, Haemophilus Influenzae Type B
- Incepta Vaccine Limited (part of Incepta Pharmaceutical Limited, Bangladesh's second largest pharmaceutical group) is the first human Vaccine manufacturing unit in Bangladesh
SCIENTIFIC OFFICER
PANACEA BIOTEC LTD.
New Delhi
10.2008 - 01.2012
- Company Overview: Panacea Biotec Ltd, New Delhi, the second largest Vaccine manufacturing organization in India, supplying its products to UNICEF and WHO
- A key member of the R&D technology transfer team for transferring technology for the production of 13-valent pneumococcal conjugated vaccine to Panacea Biotec's vaccine production plant
- Panacea Biotec Ltd, New Delhi, the second largest Vaccine manufacturing organization in India, supplying its products to UNICEF and WHO
Education
Master of Technology (M.Tech) - Bio-Technology Engineering
Madhav Institute of Technology and Science
08.2008
Bachelor of Technology (B.Tech) - Bio-Technology Engineering
Kurukshetra University
Kurukshetra, Haryana01.2006
Skills
- Good analysis and troubleshooting capabilities
- Communication Skills
- Good team player, with professional responsibility
- Leadership quality
- Facilitation and organizational skills
- Efficient in working with Windows, Microsoft Office tools like MS Word, Excel, PowerPoint, and Outlook Express
Certification
· Successfully completed Google course certification on “Foundations of Project
Management” in Sep’21.
· Successfully completed Google Course certification on “Project Initiation”.
· Successfully completed Google Course certification on “Project Planning”.
· Successfully completed Google Course certification on “Project Execution”.
· Successfully completed certification course on Project Management 101 from Mind Tools
for Business (Emerald Works)
Languages
- English
- Hindi
References
- Dr. Kishor Kumar Koshe, Sr. Vice President, Torrent Pharmaceutical Limited, Dahej, Bharuch
- Mr. Kiran Kumar, Lead Operations, Aspire Pharmaceutical Limited, UK
Disclaimer
I hereby declare that all the statements made in the above resume are true to the best of my knowledge and belief.
Motto
DEDICATION IS THE ONLY DOOR FOR SUCCESS & IMPROVEMENT.
Personal Information
- Place of Birth: New Delhi
- Father's Name: Sh. N.C. Jain
- Date of Birth: 04/14/84
- Nationality: Indian
Languages
Hindi
First Language
English
Proficient (C2)
C2
Timeline
Sr. Project Manager
Aspire Pharmaceutical Limited
01.2020 - Current
ASSISTANT MANAGER
TORRENT PHARMACEUTICAL LIMITED
08.2016 - 12.2019
ASSISTANT MANAGER
IPCA LABORATORIES LIMITED
06.2014 - 08.2016
EXECUTIVE OFFICER
INCEPTA VACCINE LIMITED
02.2012 - 01.2014
SCIENTIFIC OFFICER
PANACEA BIOTEC LTD.
10.2008 - 01.2012
· Successfully completed Google course certification on “Foundations of Project
Management” in Sep’21.
· Successfully completed Google Course certification on “Project Initiation”.
· Successfully completed Google Course certification on “Project Planning”.
· Successfully completed Google Course certification on “Project Execution”.
· Successfully completed certification course on Project Management 101 from Mind Tools
for Business (Emerald Works)
Master of Technology (M.Tech) - Bio-Technology Engineering
Madhav Institute of Technology and Science
Bachelor of Technology (B.Tech) - Bio-Technology Engineering
Kurukshetra University
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