PankajKumar Patel Godhani
Hyderabad
Summary
Dynamic leader with a total of 24 Years of Experience in Vaccine Manufacturing, Fill and finish, and Quality Assurance. Currently associated with Bharat Biotech, driving Technical Operations & product services for compliance and operational excellence. Proven track record in quality management and process optimization, enhancing production efficiency. Skilled in audit management and team leadership, delivering innovative solutions that elevate project outcomes and ensure adherence to stringent GMP standards.
Overview
1
1
Certification
23
23
years of professional experience
Work History
Lead Technical Operations & Product Services
Bharat Biotech International Limited
Hyderabad
06.2020 - Current
- Executed technology transfer and scale-up processes to ensure commercial viability.
- Conducted value stream mapping and implemented kaizen initiatives at commercial scale.
- Reviewed production workflows to identify and implement enhancement opportunities.
- Planned and controlled production processes for vaccine manufacturing across group companies.
- Monitored GMP standards mandated by national and WHO regulations.
- Led vendor identification, development, and auditing to ensure quality and compliance.
- Developed innovative ideas and solutions that improved team performance and project outcomes.
General Manager, Quality Operations & Plant Head
Fishfa Biogenics
Rajkot
02.2019 - 05.2020
- Established quality system ensuring compliance with national and WHO standards.
- Conducted scheduled internal audits to ensure quality oversight and adherence to standards.
- Reviewed QMS documents confirming adherence to cGMP guidelines, including OOS deviations and change control.
- Executed vendor and third-party audits validating compliance and quality standards.
- Harmonized SOPs across units through effective implementation of corporate policies.
- Identified continuous improvement opportunities to clarify compliance and enhance operational efficiency.
- Reviewed CAPA for timely implementation and evaluated effectiveness of corrective actions.
- Planned and executed quality management system initiatives to drive operational enhancement.
Sr. Manager and Head, Bacterial Vaccines plant
Cadila Healthcare Ltd
Ahmedabad
03.2009 - 01.2019
- Oversaw production planning, monitoring, and control at bacterial vaccine plant.
- Facilitated technology transfer and scale-up processes to ensure commercial viability.
- Executed value stream mapping to identify and implement kaizens for enhanced commercial scalability.
- Managed material and inventory with GDSO team to streamline operations and reduce waste.
- Ensured GMP compliance according to national and WHO standards.
- Prepared and controlled revenue and CAPEX budgets for manufacturing expenses.
- Conducted periodic reviews of production processes to identify areas for improvement and ensure operational excellence.
- Led and mentored team in establishing robust systems within newly established plant.
Senior Executive Production
Panacea Biotech Ltd
Baddi
11.2007 - 03.2009
- Oversaw production operations for formulation, filling, and packing of vaccines.
- Managed daily work planning and coordinated validation efforts with QA and engineering teams to streamline production processes.
- Coordinated preparation and review of new product documentation to meet manufacturing compliance standards.
- Reviewed and prepared SOPs, batch records, checklists, logbooks, and manufacturing formula records to ensure accuracy and compliance.
- Maintained quality systems documentation to ensure compliance with GMP standards.
- Participated in technology transfer teams for product transition from R&D to Baddi plant.
- Executed solution preparation and sterile filtration for various formulations.
- Operated process vessels ranging from 125 liters to 1500 liters using automated and manual CIP/SIP systems.
Executive Production (cell culture / virus production & media)
Novartis Vaccines (Chiron Behring Vaccines (P) Ltd)
Ankleshwar
06.2004 - 10.2007
- Executed animal cell culture techniques, maintaining viability in penicillin flasks, cell factories, and roller bottles to support research objectives.
- Processed virus and viral-infected materials under sterile conditions, efficiently harvesting virus from cell culture to ensure quality and compliance.
- Operated manipulators for precise handling of cell cultures in laboratory settings. for efficient handling of cell factories.
- Applied TFF techniques, including diafiltration and ultrafiltration, for effective purification processes.
- Prepared and filtered growth media for cell culture using cartridge filter techniques.
- Conducted pre- and post-integrity tests on filters utilizing diffusion and bubble point methods.
- Managed GMP records, planned daily activities, and coordinated equipment validation with QA/engineering to uphold operational standards.
- Coordinated incubation and candling of SPF eggs along with embryo pulling from SPF chick eggs.
Officer Quality Assurance
Troikaa pharma (p) ltd
Ahmedabad
08.2003 - 06.2004
- Qualified clean rooms and equipment for sterile production processes.
- Conducted process quality checks to ensure accurate dispensing of raw materials, enhancing product integrity.
- Executed line clearances, facilitating seamless transitions between production runs and minimizing downtime.
- Documented Good Manufacturing Practices, including deviation control and change management.
- Performed risk assessments and managed CAPA documentation.
- Reviewed and finalized Quality Management System documents, ensuring compliance with regulatory standards.
- Oversaw batch reprocessing and prepared detailed BMR/BPR documentation.
- Validated autoclave, oven, compression machines, liquid filling machines, and cleaning processes.
Education
M.B.A -
Manipal University
01-2026
M.Sc. Bioengineering Technology -
Periyar University
Salem, Tamil Nadu, IN01-2003
B.Sc. - Botany, Biochem, Biotech
Andhra University
Visakhapatnam, IN, AP01-2001
10 + 2 -
Andhra Prasesh - I. P. E
01-1998
X- Class -
I.C.S.E.
01-1996
Skills
- Vaccine Manufacturing (Bacterial & Viral)
- Fill & Finish - Vials (Liquid & Lyo) / Ampoules / PFS
- Aseptic Technique & Sterility Assurance
- Manufacturing Compliance assurance
- Program management and coordination (Green field & Brown field)
- Vaccine process optimization
- Quality management
- Audit management and compliance
- Risk assessment
- Project management and coordination (Green field & Brown field)
- Production planning and inventory control
- Lean management
- Strategic planning
- Complaint handling and resolution
- Understanding of RABS & Isolator Technology
- Team leadership
Certification
- Lean Six Sigma Foundations, Project Management Institute, Inc., 02/01/19
- Six Sigma: Green Belt, Project Management Institute, Inc., 02/01/19
- Approved Chemist, GSFDCA
Languages
C2 Proficient, C1 Advanced, C1 Advanced, C1 Advanced, A1 Beginner
Training
- Certificate course on Project Management – Effective Project Management - Aligned to PMBOK IV edition.
- Four days training on downstream processing at Millipore Filtration School, Bangalore.
- Three days training on 'Filtration Techniques' at Millipore Filtration School, Bangalore.
Personal Information
- Total Experience: 24 Years of Vaccine Manufacturing, Fill and Finish and Quality Assurance
- Father's Name: G. Sireesh Kumar Patel
- Mother's Name: Bhanuben Godhani
- Date of Birth: 06/19/79
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Lead Technical Operations & Product Services
Bharat Biotech International Limited
06.2020 - Current
General Manager, Quality Operations & Plant Head
Fishfa Biogenics
02.2019 - 05.2020
Sr. Manager and Head, Bacterial Vaccines plant
Cadila Healthcare Ltd
03.2009 - 01.2019
Senior Executive Production
Panacea Biotech Ltd
11.2007 - 03.2009
Executive Production (cell culture / virus production & media)
Novartis Vaccines (Chiron Behring Vaccines (P) Ltd)
06.2004 - 10.2007
Officer Quality Assurance
Troikaa pharma (p) ltd
08.2003 - 06.2004
M.B.A -
Manipal University
M.Sc. Bioengineering Technology -
Periyar University
B.Sc. - Botany, Biochem, Biotech
Andhra University
10 + 2 -
Andhra Prasesh - I. P. E
X- Class -
I.C.S.E.