Results-driven senior QC professional with over 19 years of experience in the vaccine industry, specializing in Quality Management Systems, Batch Release, and Process Validation. Proven expertise in Cleaning Validation, Product Quality Reviews, audits, and compliance ensures adherence to regulatory standards set by the FDA, EU, and WHO. Committed to leveraging extensive knowledge to enhance quality control practices and drive innovation in life-saving drugs while leading teams toward operational excellence and maintaining product integrity within the biotechnology sector. Passionate about fostering a culture of continuous improvement and ensuring the highest standards of quality in all aspects of production.
Hi, I’m
Pradip Kumar Das
Hyderabad
Summary
Overview
20
years of professional experience
Work History
M/s Biological E Limited
General Manager Quality Control- Vaccines
05.2013 - Current
Job overview
- Leading a team 95 members team for to doing day to today QC activities of stability, Viral vaccine and Bacterial vaccine testing.
- Lead and provide critical support to CFT through effective management of activities and team members supporting stability programs for late-stage clinical and commercial products, ensuring timely and compliant delivery of all CFT requirements.
- Design, plan, and oversee stability programs for new viral vaccines and marketed products, including annual stability studies and process validation (PPQ) activities in compliance with regulatory requirements.
- Proactively identify and escalate unexpected data trends and out-of-specification (OOS) results to Product Quality Teams, ensuring thorough review and attention to detail.
- Collaborate with global partners such as PATH, BMGF, and Takeda on stability program strategies, ensuring alignment with project and regulatory expectations.
- Oversight Monitoring of nonclinical studies, immunogenicity and efficacy testing programs for vaccines in qualified contract research organizations and review of report for regulatory submissions like all development vaccine like Yellow fever , MzR, PCV, Hexa, nOPV1 , nOPV2 , TCV, Bivalent vaccines.
- Led presentations to regulatory authorities (SEC and DCGI, New Delhi) to secure approval for Phase I clinical trials, effectively addressing queries related to non-clinical study outcomes.
- Member for NC3Rs WHO working group for implementation of alternative procedure for In- vivo assays
- Hyderabad, India. https://www.biologicale.com/
- Special Achievements:
- Set-up Quality Control laboratory for the release of clinical and commercial batches (In-process, DS and DP).
- Successfully released preclinical and clinical batches for the Covid19 based vaccine with support from Govt. Of India and CEPI.
- Promoted to provide critical scientific and technical support to AD vaccine group with focus on Stability, specifications, qualifications, assay transfer and release.
- Given technical training in Egypt tests related to bacterial vaccines.
- Represented Company Vaccine QC test demonstration at NRA Vietnam.
- Represented DCVMN of 3R Working group
M/s Indian Immunological Limited
Executive-I-QC
12.2011 - 05.2013
Job overview
- QC testing of Human and Veterinary Vaccines and their release.
- Leadership role to review and approve LSP.
- Established statistical Data analysis with various Software's Combistat software for biological assays.
- Assist the direct Manager in the preparation of Annual budgets, expenditures, and business objectives and submit periodic reports on activities, promotional programs, competitive activities and overall ARD business performance in the assigned area regularly in a timely and efficient manner.
- Hyderabad, India. https://www.indimmune.com/
- Member of Expert working group of Vaccines on Indian Pharmacopeia
- Involved in WHO (World health Organization), CDSCO (Central Drugs Standard Control Organization) and other regulatory audits like ANVISA, SAHPRA, from other countries.
- Implemented 3Rs in QC testing with development of analytical assay and Validation.
MACS Agharkar Research Institute
Scientist B Virology
11.2011 - 12.2011
Job overview
- Development of bacteriophage for treatment of MDM resistant bacteria
- Pune, Maharashtra, India http://aripune.org/
M/s Zydus Cadila Health care limited
Executive QC
06.2008 - 03.2011
Job overview
- Managed operations of the QC test for Rabies and Influenza Vaccine.
- Developed Animal House to test Bacterial Vaccines
- Determination of immunogenicity for H1N1, trivalent influenza and cell culture rabies vaccine.
- Coordinating with clinical trial group.
- Develop analytical method for safety test and conduct method validation.
- Prepare method validation of the product according to ICH guidelines.
- Prepare Stability schedules for the finished product.
- Perform & release current & stability batches of finished, intermediate products of vaccine and other biological products.
- Method validation of product, documentation and preparation of report of new vaccine candidate.
- Expertise in both In-vivo and In-vitro analytical methods.
- Develop new animal house for DPT bacterial vaccine.
- Facilitate local FDA authorization for new facility for DPT vaccine
- Conduct toxicity studies for H1N1, Trivalent Influenza and Cell culture vaccine. Preparation of SOPs, STPs & SPECS maintenance of documentation.
- Development of In-house Reference Standards against NIBSC Reference Standards.
- Preparation of trends of all analytical results.
- SAP release indenting of new machines and assisting in doing calibration and validation.
- Moriya Ahmedabad, INDIA. http://zyduscadila.com
Ventri Biologicals R&D
Application Specialist
07.2006 - 06.2008
Job overview
- Clinical trials of various vaccines and their potency safety in SPF eggs.
- Standardization of different protocols for IgY antibody and their application in diagnostics.
- Use of molecular biological techniques for identification of extraneous pathogens in vaccines.
- Analyzing and interpretation of clinical data obtained from trials.
- Knowledge cGMP and GLP guidelines
- Pune, Maharashtra, INDIA http://venkys.com/
- Special Achievements:
- Successfully conducted non clinical studies for Rabies, H1N1, and Trivalent influenza vaccine.
Veterinary College
JRF
01.2006 - 06.2006
Job overview
- Development of Vaccine against Mastitis in Bovines.
- Bangalore, Karnataka India
Education
Satyabhama University of Science & TechnologyChennai, India
Ph.D
01-2023
University Overview
IRCA (International Register of Certificated Auditors) from Certified QMS ISO 9001:2015 Lead Auditor
01-2018
University Overview
Federation of Laboratory Animal Science Associations from FELASA C CERTIFICATE
09-2017
University Overview
MVSc from Microbiology
01-2005
University Overview
Veterinary & Animal Science BVSc &AH from DVM
01-2003
University Overview
5 years Degree
Skills
Laboratory information management system (LIMS)- Electronic note book (eLN),
Good Document Management System (GDMS), Bioassist and Combistat Software etc
OOS or OOT, Change Control and Deviation through the Quality tracking system (Trackwise)
Summary of Expertise
Summary of Expertise
- Steering committee member of NC3R , Humane society and committee member in WHO TRS on 3Rs
- Member of expert working group Vaccines in Indian Pharmacopeia.
- Collaborated and successfully technology transfers of vaccines PT Biofarma Polio Vaccine, Takeda Tetravalent Vaccine and nOPV1 Hexa S19 from PATH BMGF.
- Review all analytical Viral and bacterial assays as per compendia requirements.
- Led stability programs for vaccine/biologic products across development and commercial stages
- Designed and executed stability protocols as per regulatory guidelines like ICH Guideline: Q1A(R2) ,WHO TRS and ICH guidelines.
- Analyzed stability data to determine product shelf-life and storage conditions
- Managed stability chambers and ensured compliance with GMP standards
- Collaborated with QA, QC, and regulatory teams for submissions and audits
- Conducting analytical method validation as per regulatory guidelines
- Trends Analysis and proof check data for vaccines.
- Prepare monthly report and give presentation progress report for above mentioned vaccines.
- Involved in WHO (World health Organization), CDSCO (Central Drugs Standard Control Organization) and other regulatory audits like ANVISA, SAHPRA, COFEPRIS, TANZANIA, PHILIPINES, Malaysia and CMO.
- Oversight Monitoring of nonclinical studies, immunogenicity and efficacy testing programs for vaccines in qualified contract research organizations and review of report for regulatory submissions
- Presentation to regulatory authorities SEC (Subject Expert Committee) DCGI (Drug Controller General of India), New Delhi for permission of Clinical trials (Phase-1) and address their queries related to non-clinical studies.
- Presentation to RCGM (Review Committee on Genetic Manipulation), Department of Biotechnology, New Delhi India on new recombinant vaccines for permission for non- clinical studies and outcome of results.
- Participate cross-functionally across the organization including with Global Project Teams, Regulatory, Clinical, Quality and Manufacturing for the outcome of non-clinical studies for potential vaccine candidate.
- Implemented various continuous improvement programs like Right First Time, Maintenance Day, and CPV.
Timeline
General Manager Quality Control- Vaccines
M/s Biological E Limited
05.2013 - Current
Executive-I-QC
M/s Indian Immunological Limited
12.2011 - 05.2013
Scientist B Virology
MACS Agharkar Research Institute
11.2011 - 12.2011
Executive QC
M/s Zydus Cadila Health care limited
06.2008 - 03.2011
Application Specialist
Ventri Biologicals R&D
07.2006 - 06.2008
JRF
Veterinary College
01.2006 - 06.2006
IRCA (International Register of Certificated Auditors) from Certified QMS ISO 9001:2015 Lead Auditor
Federation of Laboratory Animal Science Associations from FELASA C CERTIFICATE
MVSc from Microbiology
Veterinary & Animal Science BVSc &AH from DVM
Satyabhama University of Science & Technology
Ph.D