P. Narindra Kumar has over 12 years of experience in vaccine manufacturing, process development, and quality management at companies including Shantha Biotechnics Pvt Limited, Panacea Biotech, Zydus Cadila Healthcare Limited, and Indian Immunologicals Limited. He has expertise in the production of viral vaccines including hepatitis A, rotavirus, rabies, and H1N1 using substrates such as MRC5, Vero, and primary chick embryo cells. Currently serving as Senior Manager at Shantha Biotechnics, his responsibilities include planning, supervision, and management of viral vaccine bulk manufacturing divisions.

1. P.Narindra kumar, Page
RESUME
P.NARINDRA KUMAR
Shantha Biotechnics Pvt Limited (SBL),
A Sanofi Company,
Medchal, Hyderabad, Telangana, India.
Phone (Mobile): +91-8008188686
Email: narindrakumar.pola@sanofi.com
STRENGTHS:
∗ 12 years of on-the-job experience in a variety of Manufacturing, Process Development in
Human vaccine manufacturing..
∗ Clear understanding of Manufacturing and Quality requirements for commercialisation of a
biotech product and the related documentation.
∗ Ability to move a product / project from Conception stage to Commercial application, using
optimised upstream and down-stream processes developed by self by meeting / exceeding
the requirements as applicable.
∗ Bulk manufacturing experience with viral and bacterial biotech products.
∗ Fast learner and can carry-out any biotech product manufacturing/Process development
related function with assurance, and if required at short-notice with calm and assurance.
∗ Organized and managed teams of people (3–65 in number) by effective co-ordination of all
activities towards accomplishment of all the targets of a function.
∗ Has a high degree of self-motivation to succeed in any task as to satisfy all the stakeholders.
∗ Expert in handling of aseptic activities process design and execution.
∗ Good knowledge and hands-on experience in MS-Office / Open Office applications.
∗ Good Knowledge in facility Lay out design, equipment/facility qualification and validation
CAREER OBJECTIVE:
To pursue a challenging career that provides an open environment for growth in top echelons of
project / manufacturing management, by nurturing the traits of being a good team player –
technical excellence with continuous improvement, innovativeness and by being ready to accept
higher level responsibilities, based on experience gained in industrial environments.
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2. P.Narindra kumar, Page
Resume Summary
Proficient in Vaccine bulk manufacturing
Work Experience : 12 years
Skills
: Manufacturing of Viral Vaccines Production including cell
propagation, Purification, Formulation.
Industry : Biotechnology & Life Sciences
Category : Pharmaceutical / Biotechnology
Roles
: Biotechnology Product Development, Middle Management in
Manufacturing and Practices (cGMP)
Current Employer : Shantha Biotechnics Limited (A Sanofi Company), Hyderabad
Previous Employer(s)
: Indian Immunologicals Ltd.( Hyderabad and Ooty),
Zydus cadila health care limited (Ahmadabad)
Panacea biotech ( Lallure )
Highest Degree Held : MSc. Biotechnology and Pursuing PhD in Biotechnology
Preferred Job Location : Anywhere
Passport No. : L4112478 Valid until: 25/08/2023
PROFESSIONAL EXPERIENCE:
1. 9th
July2010 to till date: Sr. MANAGER, Viral Vaccines Shantha Biotechnics Pvt
Limited (SBL), A Sanofi Company, Medchal, Hyderabad, Telangana, India.
Hepatitis –A Bulk Mfg.( MRC5 cell culture ) Roles:
* Overall Planning, supervision and management of divisional functions, including
Critical role for technology transfer for Hepatitis –A bulk at manufacturing scale.
 In charge and HOD for Hepatitis –A bulk manufacturing.
 Involved from technology transfer to Engg.trial at commercial scale of Hepatitis
–A bulk manufacturing.
 Qualification and validation of new facility.
 Cell scale up, Harvest, Purification and inactivation and storage of virus bulk.
 Involved facility modification, qualification and validation.
Rota bulk Mfg.( Vero cell culture ) Roles:
* Overall Planning, supervision and management of divisional functions, including new
process development for Rotavirus Monovalent Bulk at manufacturing scale.
 In charge and HOD for Rota bulk manufacturing.
 Involved from process development, clinical trials and commercial scale
production of Rota bulk manufacturing.
 Developmental studies on Scale – up and handling TCFs, cell stacks for Vero
cells propagation.
 Standardization of harvest time based on Cytopathic effect (CPE).
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3. P.Narindra kumar, Page
 Conducting Experiments for standardization multiplicity of infection (MOI)
 Harvest, Clarification, stabilization, Distribution and storage of virus bulk.
 Involved facility modification, qualification and validation.
 Helped the team in completing all requirements (documentation, facility
readiness, operator training, aseptic techniques etc.) to start Aseptic Process
Simulation runs and commercial manufacturing of roar bulk.
 Preparation of virus seed bank (WVS)
 Active participant in new Bioreactor facility layout design from conceptual lay
out preparation to final URS approvals. Objective is to improve commercial
viability of process by increasing virus titers and volumes in bulks.
 Handling of Change controls, Deviations, CAPAs and other QMS documents.
 Preparation of Master formula records (MFR) and Batch Manufacturing Records
(BMR), SOP, RST pertaining to Rota viral vaccine facility and instruments and
process.
 Contributions:
 Played vital / lead roles in cGMP implementation, Aseptic techniques
implementation and Facility modification& qualification as per current regulatory
requirements.
 Major contribution for preparation and successful submission of dossiers to regulatory
authorities on Rota vaccines.
 Successfully completion of Rota process validations other Rota commercial stockpile
batches without any sterility failure and non-compliance in entire ne year.
Note: Rotavirus vaccine is a tetravalent vaccine, produced using Vero Cells as
substrate, and four rotavirus Bovine-Human reassortants strains.
2. December 2009 to July 2010: Asst. MANAGER, Production (Viral Vaccines), Panacea
Biotech, Lalru ,Panjab, India.
Roles:
* Overall Planning, supervision and management of H1N1 bulk upstream production.
* Contributions: In- charge for Swine Flu’ (H1N1) upstream production
 Receiving of chick Eggs, Pre incubation, Inoculation ,candling and Harvesting of
chick allantoic fluid
 Purification of allantoic fluid.
3. September 2007 to December 2009: OFFICER Rabies production, Zyduscadila health
care ltd. Ahmadabad, Gujarat
 Roles:
 Rabies Vaccine Projects(Duck embryo):
* In charge for Rabies antigen purification by Zonal centrifugation, clarification and
stabilization.
* Formulation of Rabies antigen.
* Rabies Vaccine Projects(Chick embryo-Primary cell culture):
* In charge for Rabies antigen purification by Zonal centrifugation, clarification dia-
Filtration.
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* Active participant for Qualification and validation of facility and equipments.
* Qualification media vessels and CIP systems.
* H1N1 Vaccine Projects (Chick embryo-Primary cell culture):
* In charge for H1N1 downstream process development and optimization of process
parameters, like Zonal centrifugation, clarification and dia-Filtration.
* Qualification and optimization of TFF operational conditions.
* Preparation, Review / Revision of all internal documents, procedures
(SOPs/RSTs,MFR and BMRs).
* Qualification/validation of Process Equipments
♣ Contributions:
* Played vital / lead roles in Rabies antigen purification and H1N1 downstream
process standardization and development of critical parameters.
* Removal of impurities by sucrose differential grades and saved more than 100MINR.
4. June 2005 to September 2007: OFFICER, PRODUCTION, Indian immunological
limited, Hyderabad, A.P & Ooty, Tamilnadu.
 Roles & Contributions:
 DPT production:
* Material preparation and monitoring of area and equipments.
* Preparation of seed culture.
* CIP and SIP of 100L and 500L fermenters.
* Handling of 50L, 100L and 500L fermenters.
* Harvesting, Clarification and dia filtration of antigens.
* Precipitation, centrifugation and Inactivation and sterile filtration of antigens.
 Rabies production (Vero cell based):
* In charge for Downstream of Rabies antigen purification by Zonal centrifugation and
dia-Filtration.
* Handling of SOPs, RSTs, BMR and respective documents.
* Formulation of Rabies antigen.
* Active participant for vial washing and filling
♣ Contribution: Improvement of Rabies antigen Purification to reduce the Human
albumin content and improve the Aseptic techniques to reduce the sterility
failure of bulk.
AUDITS FACED
∗ WHO audit for Rabies
∗ DCGI for Rota
∗ Bio containment audits-Sanofi
∗ GQD audits – Sanofi
∗ Internal Audits and self inspection
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EDUCATION:
Degree Duration University & Institute Grade / % Other Details
M.Sc. 2001–2003
Andhra university ,
Vishakhapatnam
I Class
Project :
Enterotoxaemia vaccine
manufacturing.
B.Sc. 1997-2000
DNR college,
Bhimavarama
I Class with
Distinction,
-NA-
TECHNICAL SKILLS: Hands-on experience in,
 Expert in Aseptic process design of viral and bacterial bulk manufacturing.
 Single use bags for media holding.
 Handling of Duck embryo and chick embryo primary cell culture
 Handling of Vero cells ,MRC5 cells and Tissue culture flaks handling(T-75 to CS40).
 Fermentation of bacterial and cultures at shake-flask / pilot & industrial fermentor levels.
 Good knowledge in Facility qualification and validation.
 Good knowledge in Facility lay out design and assessment.
 Good expertise in cGMP methodologies, documentation, process / method / cleaning
validations.
 Good knowledge on cost reduction program without effecting and compromising the quality
and compliance.
EXTRA-CURRICULAR ACTIVITIES:
★ Attended Training (4 weeks) for cGMP requirements for biotech and Health industries by
DBA (David begg associates).
★ Training completed for “Project management” for project charter preparation.
★ Certified training course completed for “Essential of Project management” for biotech
industry.
★ Training completed for “Management essentials”.
★ Implementation of Lean techniques in Work place.
★ Qualified/Trained Global quality Auditor (GQD) for Both Biological and API
★ Attended to 13th edition of Bio Asia, Hyderabad, India.
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6. P.Narindra kumar, Page
★ Attended to 17th
International congress for infectious disease ,hyderabad, India
DECLARATION:
I hereby declare that the statements made are true, complete and correct to the
best of my knowledge and belief.
Place: Hyderabad
Signature
(P.Narindra kumar)
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7. P.Narindra kumar, Page
★ Attended to 17th
International congress for infectious disease ,hyderabad, India
DECLARATION:
I hereby declare that the statements made are true, complete and correct to the
best of my knowledge and belief.
Place: Hyderabad
Signature
(P.Narindra kumar)
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