SUSHIL KUMAR GUPTA
Biotechnologist
Sydney,NSW
Summary
Scientist with more than 19 years of experience in Bio-process development and Manufacturing support.
Motivated achiever with a proven track record of developing processes from laboratory to commercial scale.
An effective leader and team builder, skilled in training, developing, and motivating others with the ability to consistently achieve objectives.
Exceptional problem solver with keen ability to resolve system/process/design level issues.
Proven planning and organizational adeptness and the ability to maintain superior levels of knowledge management systems.
Excellent knowledge of Biopharmaceutical quality and regulatory systems.
Overview
19
19
years of professional experience
Work History
Head of Process Development
NeuClone Pty Ltd
Sydney, Australia
11.2019 - Current
- Heading Upstream and downstream process teams for the development of biosimilars
- Developed platform approach of biosimilar development for regulatory advice [e.g., BIA]
- Coordination with Analytical and Cell line development [CLD] teams for setting up Quality Target Product Profile [QTPP] and other associated activities
- Lead for selection of Contract Development and Manufacturing Organizations [CDMOs] for clinical supply of phase I/III material for biosimilars
- Assisted in selection of clinical research organization [CRO] for phase III clinical trial of a biosimilar molecule
- Supporting regulatory-related queries for clinical phase III [Type II meeting] for a biosimilar
- Recruitment and budgeting for expanding development capabilities
Sr Principal Scientist & Head
Syngene International Ltd, A Biocon Group Co.
Bangalore, INDIA
03.2016 - 10.2019
- Managed a team of 21 employees, overseeing hiring, training, and professional growth of employees.
- Led the process development team in the delivery of global clients mostly US-based client's projects, resulting in retaining old clients and adding new clients
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Principal Scientist and Head
Syngene International Ltd, A Biocon Group Co.
Bangalore, INDIA
04.2014 - 03.2016
- Program Managership for End to End mAb projects.
- Process development for Monoclonal Antibodies & therapeutic proteins.
- Implementation of Quality by design [QbD] concept using DOE, FMEA, and statistical approaches
- Scale up of upstream process and technology transfer to production.
- Upstream scale-down model establishment, qualification & process characterization
- Routine telecoms with clients to update the status of ongoing projects.
Sr. Research Scientist
Syngene International Ltd., A Biocon Group Co.
Bangalore, INDIA
04.2011 - 03.2014
- Program Managership for End to-End monoclonal antibody [mAb] projects
- Process development for monoclonal antibodies & therapeutic proteins
- Scale up of upstream process and technology transfer to production
- Upstream scale-down model establishment, qualification & process characterization
- Routine telecoms with clients to update the status of ongoing projects
- Supervision of the lab., troubleshooting the process problems
- Costing, budgeting, and technical recruitment
- Provide ongoing technical and scientific support for unit operations for the production of biological
- Review of various documents like BPR, SOP, and EOP & BMRs
- Monitor, validate, and troubleshoot issues related to cell culture
- Support technology transfer of new processes
- Support regulatory inspections and answer queries, if raised
- Perform lab-scale experiments to improve process efficiencies
Scientist
Intas Biopharmaceutical Ltd
Ahmedabad, India
10.2008 - 04.2011
- Process development for Monoclonal Antibodies (Chimeric & Humanized)
- Scale up of USP processes and technology transfer to production
- Successfully developed the process for the Chimeric & Humanized Antibodies production at Bioreactor level
- Improved 2-fold productivity of CHO based product by media, feed and process optimization
- Reduced up to 30% manufacturing cost of CHO based recombinant therapeutics by process improvement.
Sr. Scientist/Scientist
Panacea Biotec Ltd
New Delhi, India
04.2006 - 10.2008
- Development of Clone for Glycoprotein & mAbs
- Upstream process development of various monoclonal antibodies (mAbs) and fusion proteins
- Documentation required for regulatory submission
- To provide training to juniors & Colleagues in Cell Culture
- Costing, budgeting, and technical recruitment
- Successfully developed the clone & process for Darbepoetin.
Senior/Research Associate
Wockhardt Ltd
Aurangabad, India
05.2003 - 04.2006
- Development & process optimization of Erythropoietin in Chinese Hamster Ovary [CHO] based expression system
Education
Master of Science (M.S) - Biotechnology
LNMU
INDIABachelor of Science (B.S) - Biotechnology
St. Columba’s College
INDIACertificate Course in Project Management - Project Management
Australian Institute of Management
Sydney2022
Skills
- Process and procedure development
- Continuous professional development
- Knowledge of Lean Six Sigma processes
- Project Management
- Team building, handling and training
- Costing and budgeting
- Technical recruitment
- Lab design and equipment selection
- CDMO and CRO selection
- Regulatory support
Accomplishments
- Attended Upstream Seminar organized by Merck in Bangalore, India (June 2016)
- Attended Advance Training on MFCS organized by Sartorius Stedim, Gottingen, Germany (29th Nov.2011 to 1st Dec.2011
- Attended Comparability and Biosimilarity for Biologics organized by IBC Asia (S) Pte Ltd Asian Subsidiary of Informa Group held at Grand Copthorne Waterfront, Singapore (Dec 2007)
- Attended a training on An introduction to Design Scale up-Validation of Downstream processing in Biotechnology Application organized by Millipore (INDIA) Pvt Ltd., Bengaluru (Dec 2004).
Affiliations
European Society for Animal Cell Technology (ESACT), Vienna, Austria
Bioprocessing Network (BPN), Sydney, Australia
Timeline
Head of Process Development
NeuClone Pty Ltd
11.2019 - Current
Sr Principal Scientist & Head
Syngene International Ltd, A Biocon Group Co.
03.2016 - 10.2019
Principal Scientist and Head
Syngene International Ltd, A Biocon Group Co.
04.2014 - 03.2016
Sr. Research Scientist
Syngene International Ltd., A Biocon Group Co.
04.2011 - 03.2014
Scientist
Intas Biopharmaceutical Ltd
10.2008 - 04.2011
Sr. Scientist/Scientist
Panacea Biotec Ltd
04.2006 - 10.2008
Senior/Research Associate
Wockhardt Ltd
05.2003 - 04.2006
Master of Science (M.S) - Biotechnology
LNMU
Bachelor of Science (B.S) - Biotechnology
St. Columba’s College
Certificate Course in Project Management - Project Management
Australian Institute of Management
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