Dr.Shilratna Walke
Production
Mumbai,MH
Summary
Led establishment of GMP facility for food, probiotics, and growth factors, ensuring compliance with industry standards. Developed and submitted project proposals to secure funding for facility operations and expansion. Collaborated with cross-functional teams to streamline processes and enhance product quality. Achieved significant milestones in project timelines and budget management.
Overview
16
16
years of professional experience
Work History
Research Scientist
Himedia Laboratories Pvt. Ltd.
05.2024 - Current
- Responsibilities
- Work area R&D microbiology upstream and downstream
- Playing a key role to set up a scale up facility for the production of linear polysaccharide, probiotics and recombinant bacterial.
- Process characterization and data analysis of report generated at pre-pilot scale production.
- Bacterial culture fermentation, scale-up, from 10 L to 1000L bioreactor.
- Bacterial culture scale down to identify root cause and to meet lower drug substance demand in shortage of product.
- Downstream processing to get final product.
- Troubleshooting during batch processing.
- Actively involved in setting up new GMP facility for scale up process.
Assistant Manager
Biological E Ltd.
06.2023 - 12.2023
- Responsibilities
- Work area up-stream and training new joiners.
- Performance qualification of 1000L Bioreactor (Fed Batch).
- Qualification document preparation.
- SOP and BMR preparation and review.
- Media simulation protocol preparation.
- Team management and safety management.
Sr. Executive
Zydus Cadila Health Care Ltd.
09.2017 - 04.2023
- Responsibilities
- Cleaning and operation of 1000 L fermenter.
- Preparation of fermenter medium, inoculation, revival of lyophilized working seed.
- Checking purity of bacterial culture by gram staining.
- Determining lines flocculation test (Lf) and O.D as batch proceeds.
- Harvesting, microfiltration, ultra-filtration, purification by ammonium sulphate, de-toxification and dia-filtration and final sterile filtration using 0.2 μ filters.
- Strictly following GMP & GDP while working in process area.
- Process SOP preparation, scientific and technical report preparation, review.
- Preparation and production side review of URS, QRM, FMEA, BMR &MFR.
- Active role in defending Internal/External audit and manufacturing compliance.
- Played a key role in area modification as per WHO requirements/norms under the guidance of expert team.
- Support to QMS team for risk assessment, CAPA, deviation, OOS and OOL.
- SAP for raw material stock overview, followed by PO, Breakdown initiation and drug substance updating remaining quantities and statistical analysis using tools like d solver software and data management using SAS.
Senior Research Fellow
Savitribai Phule Pune University
01.2014 - 01.2017
- University Grant Commission Project: Development of encapsulated trivalent DPT vaccine using biodegradable chitosan polymer as oral drug delivery in collaboration with ‘Serum Institute of India Pvt Ltd.
Research Scholar
Apte Research Foundation
01.2015 - 01.2016
- RP 33/1516 “Effect of trivalent oral vaccine using biodegradable polymers on BALB/c mice’as part of thesis entitled “Development of trivalent DPT oral vaccine using biodegradable polymers (Note: Samples were tested on mice to prove in-vivo efficacy of the product)
Junior Research Fellow
Savitribai Phule Pune University
01.2012 - 01.2014
- Instrumentation results interpretation: FTIR, TGA, XRD, SEM ,EDS, HPLC, ELISA, SDS PAGE, Micro particle- size analyzer with zeta potential In-vitro and In-vivo characterization, scientific and technical report preparation and analysis.
Lab Technician
National Institute of Virology
01.2010 - 01.2011
- National Institute of Virology 2010 — 2011 Techniques;
- Efficiently worked on Swine Flu (H1N1) outbreaks.
- Virus isolation and identification of Avian influenza and Swine Flu viruses by reverse transcriptase polymerase chain reaction (RT-PCR).
- Hemagglutinin (HA) subtyping.
- Neuraminidase (NA) subtyping.
- Implemented DNA, RNA Extraction.
- Electrophoresis and post PCR Purification techniques, RT-PCR.
- Real Time PCR, Sequencing techniques, Sequencing and Phylogenetic analysis, credited for designing primers for PCR.
- HA and NA gene sequencing using Mega 5software.
- Calibration of pipettes, maintaining lab records for swine flu, avian influenza samples, instruments and chemicals.
Education
Ph.D. - Biochemistry
Savitribai Phule Pune University
Pune01.2017
M.Sc. - Biotechnology
Fergusson College, University of Pune
Pune01.2009
B.Sc. - Biotechnology
D.Y. Patil College, University of Pune
Pune01.2007
H.S.C. - undefined
Maharashtra state board
01.2004
S.S.C. - undefined
Maharashtra state board
01.2002
Skills
Fermentation technology-Upstream & Downstream R&D, Industrial Production - Hands on operating bioreactors 10 LTRS TO 1000 LTRS scale up & scale down technology, Equipment qualifications- IQ/OQ/PQ/RA, TFF Operation, scientific data analysis, sterile filtration activity of drug substances, media simulation, QMS, QRM, VOLZA, SAP module, maintaining material stocks and online entry in SAP related transaction (Process order Generation (PO), team management, GMP plant design and validation
References
Available on request
Accomplishments
- UGC meritorious fellowship
- Gate qualified 2009.
LIST OF PUBLICATIONS
- ShilratnaWalke, Gopal Srivastava, Milind Nikalje, Jignesh Doshi, Rakesh Kumar, Satish Ravetkar, Pooja Doshi
- Physicochemical characterization of chitosan prepared form shrimp shell and investigation of its antibacterial, antioxidant and tetanus toxoids entrapment efficiency International journal of pharmaceutical sciences review and research, Int. J. Pharm. Sci. Rev. Res., 26(2014)215–225.
- Shilratna Walke, Gopal Srivastava, Milind Nikalje, Jignesh Doshi, Rakesh Kumar, Satish Ravetkar, Pooja Doshi
- Fabrication of chitosan micro and nano spheres using vanillin/TPP dualcrosslinkers for protein antigens encapsulation, Carbohydrate Polymers,128(2015)188–198.
- Gopal Srivastava, Shilratna Walke, Dilip Dhavale, Wasudeo Gade, Jignesh Doshi, Rakesh Kumar, Satish Ravetkar, Pooja Doshi
- Tartrate/tripolyphosphate asco- cross linker for water soluble chitosan used in protein antigens encapsulation, Int. J. Biol. Macromole. 91 (2016) 381–393.
- Shilratna Walke, Gopal Srivastava, Dilip Dhavale, Jignesh Doshi, Rakesh Kumar, Kalpana Pai, Chinmayee Bar Routaray, Pooja Doshi
- Preparation and characterization of microencapsulated DwPT trivalent vaccine using water soluble chitosan and its in- vitro and in-vivo immunological properties, Int. J. Biol. Macromole, February 2018, Pages 2044-2056
- Physiochemical, antibacterial and pharmaceutical properties of chitosanprepared from shrimp shells, International seminar on Emerging trends in synthetic organic and medicinal chemistry (ESMC-2013) held at Department of Chemistry, Vikrama Shimhapuri University; Nellore, A.P. India during 13-15th November, 2013.
Timeline
Research Scientist
Himedia Laboratories Pvt. Ltd.
05.2024 - Current
Assistant Manager
Biological E Ltd.
06.2023 - 12.2023
Sr. Executive
Zydus Cadila Health Care Ltd.
09.2017 - 04.2023
Research Scholar
Apte Research Foundation
01.2015 - 01.2016
Senior Research Fellow
Savitribai Phule Pune University
01.2014 - 01.2017
Junior Research Fellow
Savitribai Phule Pune University
01.2012 - 01.2014
Lab Technician
National Institute of Virology
01.2010 - 01.2011
Ph.D. - Biochemistry
Savitribai Phule Pune University
M.Sc. - Biotechnology
Fergusson College, University of Pune
B.Sc. - Biotechnology
D.Y. Patil College, University of Pune
H.S.C. - undefined
Maharashtra state board
S.S.C. - undefined
Maharashtra state board