SUDEEP KUMAR AGRAWAL
Pharmaceutical Research and development professional
Ahmedabad
Summary
Proven track record of delivering customer-focused value. Successfully utilized strategic planning, team building and motivation, deliberate execution, and budget management to drive results in alignment with corporate vision with highest ethical standards.
Over 30 years of experience consistently creating enduring excellence by spearheading strategic and technical direction to the research division.
Expertise in directing pharmaceutical product development, specifically injectable, ophthalmic and oral products for regulated markets. From conceptualization to commercialization, overseen the development of a diverse product portfolio including NCEs, liquid injectables, dry powder injectables, injectable suspensions, lyophilized injectables, complex injectables, ophthalmic solutions and suspensions, drug-device combination products, and radiopharmaceutical products. Effectively led specialized teams in drug-device development and radionuclide development to ensure successful market deployment.
Overview
29
29
years of professional experience
3
3
Languages
Work History
EXECUTIVE VICE PRESIDENT - RESEARCH AND DEVELOPMENT
SHILPA MEDICARE LIMITED
10.2024 - 01.2025
- Company Overview: Shilpa Medicare Limited is a global pharmaceutical company based in Karnataka, India
- It manufactures and supplies API and formulation for various regulated markets and has a CDMO division for biologics and biosimilars
- Website: http://www.vbshilpa.com
- Accountable for product development of Injectable and Oral products (led formulation, analytical, tech transfer and medical affairs and clinical research) for global markets with major focus on US and EU markets including 505(b)2 opportunities
- Spearheaded design and execution of high-impact research projects, advancing field of study.
- Collaborated with multidisciplinary teams to drive project success and achieve objectives.
- Collaborated with business development and intellectual property teams for evaluating emerging research trends and unmet medical needs, positioning organization at forefront of innovation and a portfolio with best alignment organizational strengths and business outlook.
VICE PRESIDENT - RESEARCH AND DEVELOPMENT
SUN PHARMACEUTICAL INDUSTRIES LIMITED
12.2014 - 08.2024
- Company Overview: India’s largest pharmaceutical consortium spanning over 45 global manufacturing sites and serving 150 global markets which includes highly regulated markets US, EU, Japan, Canada, and Australia among others
- Website: http://www.sunpharma.com
- Accountable for Injectable and ophthalmic product development of NCE, liquid injectables, dry powder injectables, injectable suspensions, lyophilized injectable, complex injectables, drug device combination products, radiopharmaceuticals and ophthalmic products for regulated markets with major focus on US and EU markets
- Several products commercially launched
- Led research leading to development of several patents, enhancing organization's intellectual property portfolio.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
- Managed financial planning and budgeting processes, ensuring fiscal responsibility and maximizing return on investments.
- Ensured regulatory compliance at all times by implementing robust internal controls systems coupled with proactive monitoring mechanisms.
- Championed talent development programs, promoting employee engagement and retention while enhancing overall workforce capabilities.
- Built high-performance teams through effective recruitment practices focused on competency alignment coupled with ongoing performance management processes.
- Established and directed successful programs focused on complex injectables and ophthalmic programs.
- Ensured meritocracy: performance based evaluation system to assess and reward performance.
ASSOCIATE VICE-PRESIDENT - Pharma Research
HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED (NOW PFIZER INDIA)
04.2011 - 11.2014
- Company Overview: Website: http://www.hospira.com
- Led India site R&D injectable formulations from the Chennai research center
- Website: http://www.hospira.com
DIRECTOR - Pharma Research
HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED (NOW PFIZER INDIA)
04.2010 - 04.2011
- Company Overview: Website: http://www.hospira.com
- Led India site R&D injectable formulations from the Chennai research center
- Website: http://www.hospira.com
DIRECTOR - Pharma Research
ORCHID HEALTHCARE LIMITED
06.2008 - 03.2010
- Company Overview: Website: http://www.orchidpharma.com
- Handled major part of the organization’s product pipeline (including P(iv) for submission to regulated markets viz.USA, EU countries, SA, Australia, New Zealand etc from selection, strategy development to commercialization
ASSOCIATE DIRECTOR - Pharma Research
ORCHID HEALTHCARE LIMITED
04.2007 - 05.2008
- Company Overview: Website: http://www.orchidpharma.com
- Formulation lead for R&D injectable formulations from the Chennai research center
PROJECT MANAGER
DR. REDDY'S LABORATORIES LIMITED
12.2002 - 03.2007
- Company Overview: Website: http://www.drreddys.com
- Led team of people from various disciplines and responsible for many of the P(iv) filings of the organization
- Successfully completed formulation of eleven solid oral products for which ANDA was filed
- Three of these were P(iv) filing
- Five of the products successfully commercialized
- Represented the department during the OHSAS audit which got OHSAS 18001 certification for the plant
- Selected to represent the organization to the USFDA regarding solid state characterization of pharmaceutical substances especially polymorphism
- Website: http://www.drreddys.com
DEPUTY MANAGER
ZYDUS CADILA HEALTHCARE LIMITED
11.1999 - 12.2002
- Website: http://www.zyduslife.com
- First person selected to initiate the organizations foray into regulated markets and lead the product development team for the following markets – US, Europe, Australia, New Zealand and South Africa
- First product launched for the European market which got MCA approval for Zydus Cadila
RESEARCH ASSOCIATE / SCIENTIST – II
WOCKHARDT RESEARCH CENTER/ TORRENT RESEARCH CENTER
09.1995 - 11.1999
- Website: http://www.wockhardt.com
- Website: http://www.torrentpharma.com
- Executive level professional responsible for oral pharmaceutical product development while collaborating with other functions.
Education
Google Professional Career Certificate - Project Management
Coursera
Online 04.2001 -
Executive Leadership Development Program -
Indian Institute of Managment
Ahmedabad, India 04.2001 -
Ph.D. - Deep Cake Lyophilization
LNCT University
Bhopal, India 04.2001 -
General Course - Intellectual Property Management
WIPO (World Intellectual Property Organization)
Certificate Course - Intellectual Property Management
IPM Learning Academy (Dr. Reddy's Laboratories)
07.2003 - 12.2003
Post Graduate Diploma - International Business
Ahmedabad Management Association
05.2000 - 03.2001
Master of Pharmaceutical Sciences - Pharmaceutics
Birla Institute of Technology, MESRA
06.1993 - 05.1995
Bachelor of Pharmaceutical Sciences - undefined
Birla Institute of Technology, MESRA
06.1989 - 04.1993
Skills
- New product development and launch including NCE's
- Drug Device Combination
- Program management and budgeting for organizational growth
- Strategic planning, teamwork, collaboration and execution
- Process compliance and audit support
- Technology transfer and product robustness assessment
- Leadership:Talent acquisition, people development and team building
- Data driven decision making and complex problem-solving
Accomplishments
- Led the team accountable for successful innovation and approval by USFDA of a novel presentation of octreotide pen injector BYNFEZIA.
- Innovated conversion of the lyophilized peptide product Cetrorelix to a ready to use liquid form in a pre-filled syringe CEZIBOE.
- Led the product development and device development team for Sumatriptan Auto Injector 3mg/0.5ml.
- Led the product development team for the first IND submission of SUN NCE program for GLP-1.
- Led cross functional trans-continental initiative for development and commercialization of FTF prostacyclin.
Patents Certifications References
Available on request
Timeline
EXECUTIVE VICE PRESIDENT - RESEARCH AND DEVELOPMENT
SHILPA MEDICARE LIMITED
10.2024 - 01.2025
VICE PRESIDENT - RESEARCH AND DEVELOPMENT
SUN PHARMACEUTICAL INDUSTRIES LIMITED
12.2014 - 08.2024
ASSOCIATE VICE-PRESIDENT - Pharma Research
HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED (NOW PFIZER INDIA)
04.2011 - 11.2014
DIRECTOR - Pharma Research
HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED (NOW PFIZER INDIA)
04.2010 - 04.2011
DIRECTOR - Pharma Research
ORCHID HEALTHCARE LIMITED
06.2008 - 03.2010
ASSOCIATE DIRECTOR - Pharma Research
ORCHID HEALTHCARE LIMITED
04.2007 - 05.2008
Certificate Course - Intellectual Property Management
IPM Learning Academy (Dr. Reddy's Laboratories)
07.2003 - 12.2003
PROJECT MANAGER
DR. REDDY'S LABORATORIES LIMITED
12.2002 - 03.2007
Google Professional Career Certificate - Project Management
Coursera
04.2001 -
Executive Leadership Development Program -
Indian Institute of Managment
04.2001 -
Ph.D. - Deep Cake Lyophilization
LNCT University
04.2001 -
Post Graduate Diploma - International Business
Ahmedabad Management Association
05.2000 - 03.2001
DEPUTY MANAGER
ZYDUS CADILA HEALTHCARE LIMITED
11.1999 - 12.2002
RESEARCH ASSOCIATE / SCIENTIST – II
WOCKHARDT RESEARCH CENTER/ TORRENT RESEARCH CENTER
09.1995 - 11.1999
Master of Pharmaceutical Sciences - Pharmaceutics
Birla Institute of Technology, MESRA
06.1993 - 05.1995
Bachelor of Pharmaceutical Sciences - undefined
Birla Institute of Technology, MESRA
06.1989 - 04.1993
General Course - Intellectual Property Management
WIPO (World Intellectual Property Organization)
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