VIJAY MISHRA
Senior Manager
Maninagar,Gujarat
Summary
Results-oriented Senior Manager with extensive experience in biopharmaceutical manufacturing and upstream process development. Proven ability to lead cross-functional teams, manage complex projects, and drive operational efficiencies within cGMP environments. Expertise in scaling up biotherapeutic production, ensuring regulatory compliance, and optimizing resource utilization to meet market demands. Seeking a challenging Senior Manager role to leverage expertise and contribute to the success of a dynamic organization.
Overview
18
18
years of professional experience
2
2
Languages
Work History
SENIOR MANAGER
CPL BIOLOGICALS LTD
01.2023 - Current
- Led an upstream cell culture team of 6, including technical supervisors, overseeing manufacturing and upstream process development of cytokines, glycoproteins, and vaccines.
- Successfully scaled up recombinant E.coli (GCSF, Ranibizumab) and CHO cell-derived Roller bottle Based Product (Erythropoietin), ensuring timely delivery of manufacturing batches to meet market requirements.
- Managed the manufacturing of recombinant insect cell-culture processes for trivalent vaccine manufacturing using Wave Bioreactor (FLU Vaccine, Rabies Vaccine).
- Spearheaded equipment selection, technical comparison, and URS preparation, optimizing capital expenditure.
- Managed Capex and Budget estimating, DS and DP upload on SAP, ensuring efficient resource allocation.
- Designed upstream workflows and timelines, streamlining processes and improving project delivery.
- Ensured timely completion of deviation, change control, and CAPA, maintaining regulatory compliance and quality standards.
- Conducted and ensured timely completion of process and equipment training, enhancing team competence and performance.
- Managed qualification and preventive maintenance schedules, ensuring equipment reliability and operational efficiency.
- Prepared and reviewed JD, SOP'S, STP'S, and TTD, BMR Documents, maintaining comprehensive documentation.
- Played a key role in facility readiness for FDA Audits, self-inspections, and various audits, ensuring compliance and successful outcomes.
Upstream Process Development
ENZENE BIOSCIENCES LTD A SUBSIDIARY OF ALKEM LABS LTD
05.2016 - 12.2022
- Led an upstream cell culture team of 5 scientists, establishing lab setup and overseeing upstream process development of cytokines and monoclonal antibodies.
- Drove early-stage process development and optimization for recombinant protein and monoclonal antibodies, enhancing product quality and yield.
- Designed experiments, analyzed data, and performed trend analysis to optimize upstream processes.
- Scaled up recombinant E.coli derived Products Like Ranibizumab,PTH, Liraglutide, Romiplostim,Sumo-protease and Tev-Protease from 5.0L (Sartorius B plus) to 30L (Sartorius C Plus) total working volume fermenter, increasing production capacity.
- Scaled up recombinant mammalian cell-culture process using perfusion technology for Mabs like Denosumab, Bevacizumab, cetuximab from T Flasks to 2L, 5L to 30 L Bioreactor using Biostat B plus and 50 STR Disposable Bioreactor, improving process efficiency.
- Optimized process and media for both microbial and mammalian products using AMBR 250 system from Sartorius Stedim, reducing costs and improving yields.
- Delivered preclinical material of different Biotherapeutics for DBT Submission on time, accelerating product development.
- Prepared and reviewed process development reports, scale-up reports, technology transfer documents, preclinical study reports, common technical documents, post-approval changes, scale-to-scale similarity reports, and risk assessment reports.
RESEARCH EXECUTIVE
UNICHEM LABORATORIES LTD
05.2015 - 05.2016
- Scaled up recombinant E.coli derived Products like GCSF, Interferon & Insulin and its analogue from 70L (I.D.M.C) to 250L (Bio-engineering) total working volume fermenter, significantly increasing production volume.
- Executed GCSF and interferon alpha 2b batches at 5L and 15L laboratory fermenter, ensuring consistent product quality.
- Performed CIP and SIP of media vessels and bioreactor using CIP SIP Skid, maintaining sterile conditions and reducing contamination risks.
- Managed batch harvesting and biomass and inclusion bodies collection by westfalia cell separator, optimizing product recovery.
- Conducted cell homogenization by GEA Homogenizer, improving product purity.
- Managed SCADA based fully automated cGMP facility, ensuring compliance and efficient operations.
- Performed autoclave validation and coordinated with QC and QA dept. for analysis and validation studies, maintaining quality standards.
- Delivered preclinical batches and clinical trial batches of different Biotherapeutics for DBT Submission in cGMP facility on time, accelerating product development.
- Conducted filter integrity testing, ensuring product sterility.
- Managed the DQ,IQ ,PQ and OQ of newly Installed Instruments and Equipments, maintaining equipment performance and reliability.
- Conducted training programs for casuals, technicians, and scientists, improving their skills and performance.
SCIENTIST
MICRO-THERAPEUTICS RESEARCH PVT LTD
10.2014 - 05.2015
- Led an upstream cell culture team of 3 scientists, establishing lab setup and overseeing upstream process development of cytokines and monoclonal antibodies.
- Optimized media and process for therapeutic proteins from Shake Flask to 2L and then 20L fermenter(Biostat B, Sartorius- Stedim), improving product yield and quality.
- Developed upstream processes for therapeutic proteins/Mabs, expanding the product portfolio.
- Optimized inoculum for batch, ensuring consistent and efficient fermentation.
- Scaled up recombinant E.coli and Pichia process from shake flask to 20 L total working volume fermenter, increasing production capacity.
- Designed lab layout and selected equipment, optimizing resource allocation.
- Prepared technical comparisons and URS preparation, supporting capital expenditure decisions.
- Managed CAPEX preparation and budgeting, ensuring efficient resource allocation.
Scientist Upstream Process Development
CADILA HEALTHCARE (ZYDUS RESEARCH CENTRE)
06.2008 - 09.2014
- Optimized process for scale-up of Recombinant Biotherapeutic protein using Microbial cell-line (recombinant E.coli and recombinant Pichia pastoris) and mammalian cell culture systems (CHO).
- Managed genetically engineered microbial cell lines as well as mammalian cell-lines (suspension cultures) at larger scale for recombinant protein production.
- Scaled up Recombinant E.coli and Pichia process from shake flask to 30L total working volume fermenter (GCSF,PTH,Enterokinase,Peg-interferon alpha 2b).
- Scaled up Recombinant mammalian cell-culture process from 50 ml bioreactor tube to 2L ,5L to 30 L Bioreactor using Biostat B plus and 50L,200L Scale up batch using STR Disposable Bioreactor for Rituximab,Adalimumab,Trastuzumab,Follicle stimulating hormone,Bevacizumab,Etarnacept,Darbepoietin &Antirabies Mab.
- Optimized cell culture process from T-flasks to Bioreactor, improving efficiency and yield.
- Characterized recombinant protein by various analytical techniques such as protein estimation by various techniques SDS-PAGE, Western Blotting, Direct and Indirect Sandwich ELISA.
- Analyzed expression and characterization of recombinant proteins by SDS-PAGE analysis using Commassie and Silver staining.
- Conducted in-house gas analysis for bioreactor batches using Gastec 100VS for CO2,N2,02,Air detection.
- Optimized lab-scale process of monoclonal antibodies expressed in CHO cells and produced by hybridoma Cells.
- Selected high yielding clones with better bio-similarity with the innovators product, through purification at small scale and its analysis by various analytical tools Optimization of the purification for various monoclonal antibodies during scale up.
- Produced monoclonal antibodies at pilot scale (20 L) with High biosimilarity with Innovator product.
- Scaled up monoclonal antibody production process up to 200 L Scale in GMP facility.
- Prepared SOPs, STPs, maintained log-books, conducted extensive literature review, created reports on new projects, and managed acquisition and maintenance of laboratory instruments.
- Prepared cell-bank Protocol for MCB, WCB And RCB.
- Prepared protocol, BMR and STP for MAb protein.
- Prepared COA for Drug Substance and Drug Product for batch release.
- Prepared Technology Transfer document.
Education
M.sc. - Industrial Microbial and Environmental Biotech.
School of Sciences Gujarat University
B.sc - Biotechnology
Gujarat Arts and Science college Gujarat University
HSC - undefined
Kendriya Vidyalaya C.B.S.E
SSC - undefined
Kendriya Vidyalaya C.B.S.E
Skills
- Upstream Process Development
- Technology Transfer
- Regulatory Affairs
- Biopharma
- FDA Audits
- CGMP
- Biopharmaceutical Manufacturing
- Scale-Up
- Microbial Cell Culture
- Mammalian Cell Culture
- Process Optimization
- DOE
- AMBR 250
- Team Leadership
- Mentoring
- Budget Management
- CAPEX Planning
- Deviation Management
- CAPA Management
- Analytical Skills
- GC
- Electrophoresis
- ELISA
- Problem Solving
- Root Cause Analysis
- Project Management
- Risk Assessment
- Risk Mitigation
- SOP Documentation
- BMR Documentation
- SAP
- Data Analysis
Languages
Hindi
English
Awards
Recognized for excellence in essay writing, demonstrating strong communication and analytical skills in the field of virology and prion biology.
Timeline
SENIOR MANAGER
CPL BIOLOGICALS LTD
01.2023 - Current
Upstream Process Development
ENZENE BIOSCIENCES LTD A SUBSIDIARY OF ALKEM LABS LTD
05.2016 - 12.2022
RESEARCH EXECUTIVE
UNICHEM LABORATORIES LTD
05.2015 - 05.2016
SCIENTIST
MICRO-THERAPEUTICS RESEARCH PVT LTD
10.2014 - 05.2015
Scientist Upstream Process Development
CADILA HEALTHCARE (ZYDUS RESEARCH CENTRE)
06.2008 - 09.2014
M.sc. - Industrial Microbial and Environmental Biotech.
School of Sciences Gujarat University
B.sc - Biotechnology
Gujarat Arts and Science college Gujarat University
HSC - undefined
Kendriya Vidyalaya C.B.S.E
SSC - undefined
Kendriya Vidyalaya C.B.S.E