Pramod Gupta
M.Sc. Microbiology
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About
With 22.5 years of experience in Biopharmaceuticals clinical development, R&D, manufacturing, Quality Control, Regulatory affairs, Pharmacovigilance and GxP. Currently serving as the DGM- Biopharmaceutical's manufacturing of Biological E Ltd, Hyderabad. Demonstrated expertise in leading viral vaccine DS manufacturing operations with over 50 employees. Deep understanding of process, cross functional coordination and team management with strong company culture and motivational leadership.
Experience
Deputy General Manager (Plant Head) - Biological E Ltd - Hyderabad
(2020-10)
- Lead the Technology transfer team for Measles, novel Oral Polio (in coordination with WHO & PATH) and Dengue vaccine from Takeda
- New Production plant commissioning, Qualification and manpower recruitment for Measles and Polio Vaccine in Bioreactor
- Lead for New facility Qualification, Instrument Qualification, Media Simulation, Protocol & SOP preparation, Cleaning validation, Risk & Gap assessment documentation
- Responsible for IBSC, RCGM, Form 29 and regulatory audits
- Recruitment of manpower and training. Currently managing 40 member Team
- Process Optimization, Yield Improvement and Process validation
- Procurement of materials for manufacturing of Clinical & PV batch
- Responsible for Regulatory Audit (WHO Prequalification and state Regulatory)
Sr. Manager - Cadila Healthcare Ltd - Ahmedabad
(2016-05 - 2020-09)
- Production Planning and Manufacturing activities supervision for Flu (DS and DP) and bacterial Vaccine (DP) as per market requirement
- Responsible for Drug Substance production of Influenza vaccine
- Responsible for Drug Product in Vial and Prefilled syringe for Tetravalent Influenza vaccine
- Responsible for Plant and Instrument Maintenance
- Responsible for procurement and qualification of new instruments
- Manpower recruitment and its deployment. Managed manpower team of about 80 different level professionals
- Collaboration with laboratories and government regulatory body for regulatory and statutory compliance and release of vaccine for market sale
- Responsible for Regulatory Audit (state Regulatory and DCGI)
- Pharmacovigilance team member
Assistant Manager- Viral Vaccine - Shantha Biotechnics Pvt. Ltd. (A Sanofi Company) - Hyderabad
(2015-05 - 2016-05)
- Implement the Quality control procedure from manufacturing technology of Hepatitis A Vaccine (Inactivated)
- Qualification of Instruments and area of Quality Control Laboratory of Viral vaccines
- Preparation of URS, Qualification protocols, SOP's, STP's, specifications and other regulatory documents
- Training of subordinates, SOPs and other trainings as required
Sr. Executive - Cadila Healthcare Ltd - Ahmedabad
(2006-08 - 2015-04)
- Biopharmaceutical Clinical development for Vaccine Upstream & Downstream Process development and Bioanalytical method development, preparation & characterization of WCB & virus seed, molecular characterization, Stability study, Inactivation, formulation development
- Process and Bioanalytical method development & its Validation
- Sourcing of new strains, host for vaccine manufacturing
- Team member for regulatory audit and coordination with regulatory body
- Responsible for procurement and qualification of instruments
- Collaboration with laboratories and government regulatory body
- Dossier preparation for new developed vaccine to regulatory agencies with Regulatory affairs department
- Pilot scale batches, commercial scale batches and clinical trials of vaccines
- Technology transfer from R&D to commercial Manufacturing Plant
QC-Microbiologist - Mapra Laboratories Pvt. Ltd - Daman
(2005-06 - 2006-08)
QC-Microbiologist - Olive Healthcare Pvt. Ltd - Daman
(2003-11 - 2005-06)
Education
M.Sc. - Microbiology - R.D. University Jabalpur (2003)
D. Pharmacy - Pharmacy - Board of Technical Education (2001)
B.Sc. - Life Sciences - D.D.U. Gorakhpur University (1996)
