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
2
2
Certifications
Work History
Deputy Manager
JODAS EXPOIM PVT LTD
9 2022 - Current
- Manage and develop 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,Pembrolizumab) 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 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 commissioning, qualification and verification of facility, equipment's etc.
- Involve in Quality Management System as per cGMP compliances.
- Responsible for 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 SME.
- Responsible for maintaining annual CAPAX and indent of raw materials and consumables.
Deputy Manager
YAPAN BIO
02.2022 - 09.2022
- Performed Downstream processing of Influenza vaccines(4 serotype) from 10L to 25L batch size and developed Adenovirus derived Covid vaccine.
- Co-ordinate with team to deliver consistency batches.
- Oversee downstream activities like chromatography, UF/DF, filtration and bulk filling.
- Co-ordinate with engineering and QA team for commissioning, qualification and verification of equipment's.
- Followed clean room behavior during batch process.
- Involved in Quality Management System as per cGMP compliances.
- Responsible for preparation of documentation like MFR,BPCR,TTD,SOP etc.
Assistant Manager
SANZYME PVT LTD
06.2020 - 09.2021
- Performed downstream processing of Human Gonadotrophin Hormone extracted from Human urine.
- Co-ordinate with team to deliver consistency batches.
- Initiated three consecutive process validation batches followed by continuous process monitoring.
- Process characterization and assessment of control strategy.
- Co-ordinate with engineering team and QA team for equipment's commissioning and qualification.
- Involved in Quality Management System as per cGMP compliances.
- Responsible for preparation of documentation like MFR,BPCR,TTD,SOP etc.
- Indent of raw materials.
Senior Executive
AUROBINDO PHARMA PVT LTD
09.2018 - 06.2020
- Performed Downstream processing of Enzyme(Sacrosidase) expressed in E.coli.
- Executed 50L scale up batches.
- Performed Downstream process activities like chromatography, UF/DF, final sterile filtration.
- Co-ordinate with engineering team and QA team for equipment's qualification.
- Involved in Quality Management System as per cGMP compliances.
- Responsible for preparation of documentation like MFR,BPCR,SOP etc.
Officer
SANOFI HEALTHCARE PVT LTD
07.2017 - 09.2018
- Performed downstream processing for manufacturing of Hepatitis B surface antigen at 750L batch size.
- Performed downstream activities like cell lysis, centrifugation, chromatography, UF/DF, filtration and bulk fill.
- BMR writing for regular batches.
- Involved in Aseptic process simulation with supervisor.
- Associated in clean equipment hold time and dirty equipment hold time activities as part of cleaning validation.
Senior Executive
HEMARUS THERAPEUTICS PVT LTD
08.2015 - 07.2017
- Performed downstream process development, optimization and scale up of FVIII, Fibrinogen and Thrombin derived from human plasma.
- Performed downstream activities like chromatography, UF/DF, filtration.
- Responsible for preparation of documentation like MFR,BPCR,TTD,SOP etc.
- Indent of raw materials.
Business Development Executive
RCC LABORATORIES INDIA PVT LTD
09.2014 - 08.2015
- Responsible for business development of MCB and WCB characterization, virus validation studies.
- Increased sales as per target requirement.
- Performed SWOT analysis.
- Developed and Implemented strategic business plans and marketing strategies.
- Prepared and delivered business review to senior management.
- Clients visit as per project requirement.
Executive
SYNGENE INTERNATIONAL PVT LTD
09.2011 - 09.2014
- Performed 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.
- Responsible for preparation of buffers, daily calibration of pH and conductivity meter etc.
- Maintained equipment usage log books, calibration log books etc.
- Performed qualitative and quantitative analytical estimation like SDS-PAGE, Bradford assay etc.
Trainee
AstraZeneca
02.2011 - 03.2011
- Trainee in Quality Control Department
Education
Master of Science - Biochemistry
Reva Institute of Science And Management
Bengaluru, India 04.2001 -
Bachelor of Science - Biotechnology,Genetics,Biochemistry
Oxford College of Science
Bengaluru, India 04.2001 -
12th Standard,WBHSC Board - Physics, Chemistry, Biology
Baruipur High School
Baruipur, India 04.2001 -
10th Standard,WBSC Board - Physical Science,Life Science,Mathematics,History
Baruipur High School
Baruipur, India 04.2001 -
Skills
Performance Improvements
Process and procedure development
Operations Management
Decision-making capabilities
Team motivation
Certification
Six Sigma Green Belt Certification
Languages
English
Hindi
Bengali
Hobbies
- Travelling
- Sports
Achievements
- Successfully completed preclinical trial batches of Pertuzumab.
- Successfully completed Phase I clinical trial campaign of Influenza Vaccine.
- Develop and optimize a process for the purification of Antisense oligonucleotides(Sequence length 18mer).
Timeline
Deputy Manager
YAPAN BIO
02.2022 - 09.2022
Assistant Manager
SANZYME PVT LTD
06.2020 - 09.2021
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
Trainee
AstraZeneca
02.2011 - 03.2011
Master of Science - Biochemistry
Reva Institute of Science And Management
04.2001 -
Bachelor of Science - Biotechnology,Genetics,Biochemistry
Oxford College of Science
04.2001 -
12th Standard,WBHSC Board - Physics, Chemistry, Biology
Baruipur High School
04.2001 -
10th Standard,WBSC Board - Physical Science,Life Science,Mathematics,History
Baruipur High School
04.2001 -
Deputy Manager
JODAS EXPOIM PVT LTD
9 2022 - Current
Six Sigma Green Belt Certification
Jan 2020
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