SUBHADEEP BASU
Deputy Manager
Hyderabad
Summary
Accomplished downstream process development, optimization, scale up to Manufacturing of Biosimilars, Vaccines, Hormones, Plasma Derived products, Oligonucleotides as a Deputy Manager with strong leadership technical and organization skills experience of 12.5 years with balancing multiple projects across large bioprocessing team in CDMO ,CRO and In-House environment. Specialized in product and process improvement and team structuring
Overview
13
13
years of professional experience
10
10
years of post-secondary education
Work History
Deputy Manager
JODAS EXPOIM PVT LTD
9 2022 - Current
- Manage and develop the performance of direct report by setting effective goals, provide timely performance feedback
- Responsible for successful process development,optimization ,scale up and technology transfer of Monoclonal Antibodies(Pertuzumab,Perbrolizumab) and Antisense Oligonucleotides.Area of focus include cell harvest clarification by Affinity Chromatography,Virus Inactivation,Polishing step by Cation Exchange Chromatography,Anion Exchange Chromatography,Nanofiltration,UF/DF,Sterile Filtration,Lyophilization
- Compilation and review of batch data
- Serves as a technical lead for process transfer of projects to GMP production facilities and also responsible for experimental design of process development studies
- Applies understanding of regulatory expectations to process development strategies.Contribute to process risk assessments applying Quality by Design principles
- Assessment of process characterization (CPP,CMA and CQA) and its control strategies
- Co-ordinate with engineering and QA team for equipment's qualification
- Involve in Quality Management System as per cGMP compliances
- Responsible for the preparation and review of MFR, BPCR, TTD, SOP, Process validation protocol, Process validation report, Drug master file etc
- Participated in various audits like CDSCO,RCGM,DCGI as a SME
- Responsible for maintaining annual CAPAX and indent of raw materials and consumables
Deputy Manager
YAPAN BIO
02.2022 - 09.2022
- Involved in Downstream processing of Influenza vaccines(4 serotype) from 10L to 25L batch size and developed Adenovirus derived Covid vaccine
- Co-ordinated with the team to deliver the consistency batches
- Oversee the downstream activities like chromatography, UF/DF, filtration and bulk filling
- Co-ordinated with engineering team and QA team for equipment's qualification
- Followed clean room behavior during the batch process
- Involved in Quality Management System as per cGMP compliances
- Responsible for the preparation of documentation like MFR,BPCR,TTD,SOP etc.
Assistant Manager
SANZYME PVT LTD
06.2020 - 09.2021
- Involved in Downstream processing of Human Gonadotrophin Hormone extracted from Human urine
- Co-ordinated with the team to deliver the consistency batches
- Initiated three consecutive process validation batches followed by continuous process monitoring
- Process characterization and assessment of control strategy
- Co-ordinated with engineering team and QA team for equipment's qualification
- Involved in Quality Management System as per cGMP compliances
- Responsible for the preparation of documentation like MFR,BPCR,TTD,SOP etc
- Involved in the indent of raw materials.
Senior Executive
AUROBINDO PHARMA PVT LTD
09.2018 - 06.2020
- Involved in Downstream processing of Enzyme(Sacrosidase) expressed in E.coli
- Executed 50L scale up batches
- Involved in Downstream process activities like chromatography, UF/DF, final sterile filtration
- Co-ordinated with engineering team and QA team for equipment's qualification
- Involved in Quality Management System as per cGMP compliances
- Responsible for the preparation of documentation like MFR,BPCR,SOP etc.
Officer
SANOFI HEALTHCARE PVT LTD
07.2017 - 09.2018
- Involved in Downstream processing for the manufacturing of Hepatitis B surface antigen at 750L batch size
- Involved in downstream activities like cell lysis, centrifugation, chromatography, UF/DF, filtration and bulk fill
- BMR writing for regular batches
- Involved in Aseptic process simulation with the supervisor
- Associated in clean equipment hold time and dirty equipment hold time activities as a part of cleaning validation
Senior Executive
HEMARUS THERAPEUTICS PVT LTD
08.2015 - 07.2017
- Involved in Downstream process development, optimization and scale up of FVIII, Fibrinogen and Thrombin derived from human plasma
- Executed downstream activities like chromatography, UF/DF, filtration
- Responsible for the preparation of documentation like MFR,BPCR,TTD,SOP etc
- Involved in the indent of raw materials
Business Development Executive
RCC LABORATORIES INDIA PVT LTD
09.2014 - 08.2015
- Responsible for the business development of MCB and WCB characterization, virus validation studies
- Increased sales as per target requirement
- Involved in SWOT analysis
- Developed and Implemented strategic business plans and marketing strategies
- Prepared and delivered business review to the senior management
- Clients visit as per project requirement
Executive
SYNGENE INTERNATIONAL PVT LTD
09.2011 - 09.2014
- Involved in Downstream process development, optimization and scale up of biosimilars, enzymes and inclusion bodies etc
- Executed downstream activities like cell lysis, centrifugation, chromatography, UF/DF, filtration
- Involved in preparation of buffers, daily calibration of pH and conductivity meter etc
- Maintained equipment usage log books, calibration log books etc
- Involved in qualitative and quantitative analytical estimation like SDS-PAGE, Bradford assay etc
Education
Masters of Science - Biochemistry
Reva Institute of Science and Management Affiliated to Bangalore University
09.2009 - 05.2011
Bachelors of Science - Biotechnology, Genetics and Biochemistry
Oxford College of Science Affiliated to Bangalore University
05.2006 - 05.2009
12th Standard(WBHSC) - undefined
Baruipur High School, Baruipur,West Bengal
Baruipur, West Bengal 04.2004 - 05.2006
10th Standard(SSC) - undefined
Baruipur High School, Baruipur,West Bengal
Baruipur, West Bengal 03.2002 - 05.2004
Six Sigma(Green Belt Certified) - undefined
VerSigma
01.2020 - 04.2020
One month QC training programme - undefined
Astra Zeneca Pvt Ltd
02.2011 - 05.2011
Skills
MS Office
Chromatography techniques
Team Management
Quality Management System
Filtration techniques
Personal Information
- Place of Birth: West Bengal
- Date of Birth: 04/04/1988
- Gender: Male
- Nationality: Indian
- Language known:English,Hindi,Bengali
References
Rajtilak Kulkarni, 9511866295, Rajtilak.kulkarni@seruminstitute.com, Serum Institute of India
Timeline
Deputy Manager
YAPAN BIO
02.2022 - 09.2022
Assistant Manager
SANZYME PVT LTD
06.2020 - 09.2021
Six Sigma(Green Belt Certified) - undefined
VerSigma
01.2020 - 04.2020
Senior Executive
AUROBINDO PHARMA PVT LTD
09.2018 - 06.2020
Officer
SANOFI HEALTHCARE PVT LTD
07.2017 - 09.2018
Senior Executive
HEMARUS THERAPEUTICS PVT LTD
08.2015 - 07.2017
Business Development Executive
RCC LABORATORIES INDIA PVT LTD
09.2014 - 08.2015
Executive
SYNGENE INTERNATIONAL PVT LTD
09.2011 - 09.2014
One month QC training programme - undefined
Astra Zeneca Pvt Ltd
02.2011 - 05.2011
Masters of Science - Biochemistry
Reva Institute of Science and Management Affiliated to Bangalore University
09.2009 - 05.2011
Bachelors of Science - Biotechnology, Genetics and Biochemistry
Oxford College of Science Affiliated to Bangalore University
05.2006 - 05.2009
12th Standard(WBHSC) - undefined
Baruipur High School, Baruipur,West Bengal
04.2004 - 05.2006
10th Standard(SSC) - undefined
Baruipur High School, Baruipur,West Bengal
03.2002 - 05.2004
Deputy Manager
JODAS EXPOIM PVT LTD
9 2022 - Current
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