Expert Details
Bioprocessing & Biopharma
ID: 739916
Ireland
In his current role as a Senior Bioprocess Development Scientist, he serves as a Project Technical Lead for downstream process projects in his company's large molecule business unit. He collaborates closely with internal stakeholders for downstream process deliverables and timelines, and assists with client collaboration and technical, project, and resource planning. Prior to this role, he was the Assistant Manager of Technical Biopharma, where he was part of Strategic Growth and Technical Global teams. His product portfolio includes Single Use Solutions, Chromatographic resins, Bioprocess chemicals- Salts, Buffer, Excipients, and Bovine Serum, to name a few.
Technical Skills:
• Hand-On-Experience in handling and processing of Mammalian cell originated protein, Lab scale volume (1L-50L scale of processing volume)
• Documentation and record maintenance, Process protocols, Technical & Process Consistency reports.
• Trouble shooting and interpretation of results, Proficiency in using Unicorn software programming.
• Handling of Instruments:
-- Chromatography System--AKTA Pilot, Pure, Explorer, Purifier (GE Healthcare)
-- TFF System -- Cogent M1, Cogent µScale (Millipore)
-- Depth Filtration-- Millistak+Pod Pilot Scale Holder (Millipore)
-- Virus Filtration at small scale (Planova and Millipore)
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2010 | Degree: Masters of Technology | Subject: Bioprocess Technology | Institution: Institute of Chemical Technology, Mumbai, INDIA |
| Year: 2008 | Degree: Bachelors | Subject: Pharmaceutical Sciences | Institution: Punjab Technical university, INDIA |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2022 to Present | Employer: Undisclosed | Title: Senior Bioprocess Scientist | Department: Research and Development |
Responsibilities:• Function as a Project Technical Lead for downstream process projects in APC`s large molecule business unit.• Collaborating and working closely with various internal stake holders for downstream process deliverables and timelines. • Client Collaboration, technical, project and resource planning. |
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| Years | Employer | Title | Department |
| Years: 2019 to 2022 | Employer: BIOCON BIOLOGICS INDIA LIMITED | Title: ASSOCIATE SCIENTIFIC MANAGER-1 | Department: Research and Development |
Responsibilities:Leading and assisting the team of Scientists and senior scientist, involved in the development, scale-up and technology transfer.• Downstream process optimization and development of Biotherapeutics (Monoclonal antibody) • Scale up and technology transfer from R&D to manufacturing process for Monoclonal antibodies • Designing, Planning Viral validation strategy for pharmaceutical manufacturing |
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| Years | Employer | Title | Department |
| Years: 2017 to 2019 | Employer: AVANTOR PERFORMANCE MATERIAL INDIA LIMITED | Title: ASSISTANT MANAGER | Department: Technical biopharma (Business development) |
Responsibilities:Functional Responsibilities: Part of Strategic Growth Technical global team-Biopharma.Product Portfolio: Single Use Solutions, Chromatographic resins, Bioprocess chemicals- Salts, Buffer, Excipients, Bovine Serum • Biopharma Account pipeline mapping, Identify and develop new customers where in solution can be provided • Identify the unique process needs of customer for customized solutions throughout the Bioprocess development (Upstream, Downstream, Formulation process) with Avantor product portfolio • Assessing customer potential and provide forecast for sales planning |
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| Years | Employer | Title | Department |
| Years: 2012 to 2017 | Employer: BIOCON BIOLOGICS INDIA LIMITED | Title: PRINCIPAL SCIENTIST | Department: Research and Development, MSAT and Manufacturing |
Responsibilities:Scale down qualification for manufacturing support and characterization studies (Preparation of Study protocol, execution of experiments, Analysis of results and preparation of Technical report)• Risk analysis of purification process based on FMEA (to identify critical process parameters) • Support and work in conjugation with MSAT team. Planning and execution of lab scale support experiments for the closure of deviations and OOS. Compilation and Trending of data generated from manufacturing batches. • Resin Lifetime study for all chromatographic steps (Affinity, AEX, CEX, HIC) for bio-similar mAb project in order to support commercial manufacturing process and various regulatory submissions. • Conducted viral validation study for bio-similar mAb project at FDA registered biologics testing facility in the USA (Philadelphia) for demonstration of viral clearance and regulatory dossier. • Process and product related impurity clearance studies for evaluating process robustness and capacity (Linkage studies for impurities clearance (CpB, Hc-DNA, LPA, HCP, Antifoam) • Variant Isolation: Isolation of various charge variants and size related impurities in their purest form required for product profiling and characterization of monoclonal antibodies. • Detailed scouting work plan preparation, experiments’ execution, reports and SOP’s writing, following the GLP/GMP documentation practices and record maintenance. • Author, review & approve technical presentations, updates, reports, process risk assessment, SOPs, Change controls & FMEA |
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| Years | Employer | Title | Department |
| Years: 2011 to 2012 | Employer: KEMWELL BIOPHARMA PVT LTD | Title: JUNIOR RESEARCH ASSOCIATE | Department: Research and Development |
Responsibilities:Execution of Consistency batches, documentation and record maintenance including routine Lab Documentation, batch records (BMR), Technical & Process Consistency Summarizing reports.• Involved in Process Development Lab set up. (Commissioning, Installation, Qualification and SOP writing of various Lab instruments), Supervise vendors for qualification functions and installation of lab instruments and equipment’s. • Assisted in various activities of Installation qualifications (IQ) during FAT for downstream processing vessels of manufacturing facility (Buffer and process tanks) • Preparation of qualification documents such as URS, DQ, IQ, OQ and execution of qualification activities. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2011 | Employer: INTAS BIOPHARMA | Title: BCIL TRAINEE | Department: Research and Development |
Responsibilities:Worked on project PEGylation and Purification of PEGylated recombinant therapeutic protein |
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Career Accomplishments
| Licenses / Certifications |
|---|
| Registered Pharmacist of Chandigarh Pharmacy Council, Chandigarh, INDIA |
| Awards / Recognition |
|---|
| • Biocon Appreciation Award in recognition for Regulatory Submission of Trastuzumab in Developed Market. • Biocon Award for “Employee of the Quarter” for outstanding performance and accomplishment for resin reusability study. • Biocon Award for being the first team to complete process characterization for biosimilar “CANMAB” for US-FDA filling. • Qualified in Graduate Aptitude Test in Engineering GATE-2008 (Pharmaceutical Sciences) conducted by IIT/IISc. • Awarded with Research Fellowship by DBT (Dept. of Biotechnology, Govt. of INDIA) for M. Tech. |
Language Skills
| Language | Proficiency |
|---|---|
| English | Fluent |