Prashant Pawde
Mumbai
Summary
A Global Project Manager with nearly 15 years of extensive experience in Project Management/Alliance management & Business development in Pharmaceutical industry offering chronicled success in product development, registrations and approvals with commercial launch for US & other regulated markets. Supervising development of ANDA, 505 (b)(2), CBE30, PAS submissions of complex generics, NCEs and finished formulations such as sterile opthalmic solutions, ophthalmic suspension, regular & complex injectables and other oral solid & liquid dosage forms. Worked in IH as well as CMO environment for development and site transfer projects till commercial launch. Actively lead the team for identifying the new CMO's across different geographies along with their technical evaluations, agreement finalizations with business negotiations. Explored potential partners for complex sterile products, lead the technical team for dossier evaluations and due diligence closures along with monitoring of potential manufacturing site quality audits for US supplies. Worked with stakeholders across EU, US, Mexico, Taiwan and other Asian countries (South Korea & China).
Overview
15
15
years of professional experience
Work History
Project Manager
Glenmark Pharma
Mumbai
07.2022 - Current
- Working as project manager for North America, EU & Canada market
- Project planning and monitoring, CMO budget and cost monitoring
- New agreement negotiations and signing along with commercial supplies tech transfer and conversion costs
- CMO identifications, technical evaluations and suitability for potential site transfers
- Commercial launch and planning along with process validations
- Potential business opportunities evaluation with new partners along with due diligence for their new dossiers for US markets
- Successfully launched 3 projects in US market with significant market value within span of 2 years
- Dosage forms - Sterile complex injectable, ophthalmic solutions, Ophthalmic suspensions, oral suspensions, oral solutions
Technical Project Manager
Rubicon Research Mumbai
02.2021 - 07.2022
- Worked as technical project manager for 505 (b) (2), NCE & ANDA projects
- Monitoring product development, scale up & exhibit batch manufacturing, project budgeting
- Clinical studies planning & monitoring
- Dosage forms - ophthalmic solutions, injectables, oral modified SR/ER tablets and capsules
- 2 products filed under 505(b)(2) category in 14 months
Technical Project Manager
Lupin research park
Pune
05.2014 - 12.2020
- Worked as R&D project manager for US/EU/Canada/Australia market
- Technical project monitoring of development and site transfer projects along with AVD approach for cost reduction
- Dosage forms - Ophthalmic solutions (Loteprednol solution), ophthalmic suspension (Tobramycin and dexamethasone suspension), sterile injectable, oral suspensions and liquids, oral tablets
- Budgeting and expense monitoring for CMO projects
- US dossier extension to Canada/AUS/EU markets
- Commercial validation batch planning and monitoring for launch
R&D Project Manager
Dr. Reddy's Labs
Hyderabad
03.2012 - 05.2014
- Worked as R&D Project Manager for NCE development, clinical studies supply for US/EU/Mexico based customers for US market
- Preparing project trackers, monitoring product development, conducting customer meetings and updating progress
- Monitoring scale up and exhibit scale manufacturing, clinical trial planning and supply management
- Dosage forms - sterile ophthalmic solutions, injectable, oral liquids & oral solids
Research Executive (Formulations)
Zydus Cadila
Ahmadabad
06.2009 - 03.2012
- Worked as Research Executive in formulation development for US & EU market
- Initial development, scale up, exhibit batch manufacturing until commercial validations
- Product development report preparation & ANDA submissions, query responses filing until approval
- Dosage forms - oral tablets, capsules, soft gelatin capsules, oral liquids
- Worked on technologies like roll compaction, multi unit particulate drug delivery systems, air jet milling, FBP & FBD
Education
M.Pharm. (Pharmaceutics) -
Swami Ramanand Teerth Marathwada University
Maharashtra, Nanded, India03-2009
Certificate Diploma in Clinical Research -
Academy of Clinical Excellence Bombay College of Pharmacy
Mumbai India10-2008
B.Pharm. -
AppasahebBirnale College of Pharmacy
Sangli, Maharashtra, India04-2007
Skills
- Global Project management
- Alliance management and business development
- Strong People Leadership & Management
- Team leader
- Insightful experience in ANDA filing for US, Europe & Canada regulated markets
- Working with stakeholders across different geographies
- Contract Management with Technical Support
- Schedule & Risk Management
- Budgeting & Cost Control
- Dossier Document Management & Due Diligence
Languages
Marathi
First Language
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Personal Details
Date of Birth - 26th April 1986
Address - 708, Iris 3, Skyi Manaslake, Bhukum, Pune 412115 (Maharashtra, India)
Timeline
Project Manager
Glenmark Pharma
07.2022 - Current
Technical Project Manager
Rubicon Research Mumbai
02.2021 - 07.2022
Technical Project Manager
Lupin research park
05.2014 - 12.2020
R&D Project Manager
Dr. Reddy's Labs
03.2012 - 05.2014
Research Executive (Formulations)
Zydus Cadila
06.2009 - 03.2012
M.Pharm. (Pharmaceutics) -
Swami Ramanand Teerth Marathwada University
Certificate Diploma in Clinical Research -
Academy of Clinical Excellence Bombay College of Pharmacy
B.Pharm. -
AppasahebBirnale College of Pharmacy
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