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)
