Sandeep Bhat
Jammu
Summary
Upstream Process Development Scientist developing and optimizing cell culture workflows for mAbs and viral vectors. Designs scale-up, transient transfection, and bioreactor strategies across shake flask, wave, and stirred-tank systems. Contributes to process characterization and tech transfer with a focus on robust upstream performance.
Overview
3
3
Languages
10
10
years of professional experience
Work History
Assistant Manager (Team Lead) Upstream Biologics
Kwality Pharma Limited
12.2025 - Current
- Served as the technical lead for CDSCO regulatory audits for Clinical Trial (CT) batches, ensuring 100% cGMP compliance and zero critical observations to obtain regulatory clearance.
Lead upstream operations for the commercial manufacturing of Erythropoietin (EPO) and development pipelines for mAbs (Pembrolizumab, Nivolumab, and Pertuzumab).
Enforce strict QMS controls on batch records, equipment logbooks, deviations, and environmental monitoring across all upstream operations.
Supervise process design, characterization, and operational optimization to enhance batch yield while maintaining critical quality attributes (CQAs).
Assistant Manager AAV/LV USP
MicroCrispr Pvt Ltd, Meril
05.2025 - 11.2025
- Spearheaded facility design, cleanroom layout, and equipment commissioning for a dedicated AAV viral vector manufacturing unit in strict alignment with cGMP standards.
- Scaled up viral vector platforms (AAV) from shake flasks to Stirred-Tank Bioreactors using HEK293 suspension systems.
- Standardized transient transfection protocols (PEI and plasmid mixes) and authored associated qualification and validation protocols.
- Coordinated daily operations to ensure smooth workflow and timely project completion.
- Streamlined communication between departments to facilitate information sharing and collaboration.
- Mentored junior staff, fostering professional development and knowledge sharing within the team.
- Led cross-functional initiatives aimed at optimizing resource allocation and operational efficiency.
Research Associate, Upstream Processing
Zydus Research Centre
04.2022 - 05.2025
- Led the design and execution of upstream processes for the production of mAbs, including cell line development.
- Manage mammalian cell culture processes using both traditional stainless-steel bioreactors (20L to 5KL) and single-use systems.
- Supported upstream process development activities, including cell culture maintenance, media formulation, and optimization.
- Assisted in the evaluation and selection of cell lines for mAb production and performed stability studies.
- Collaborated with analytical teams to analyse and characterize mAbs and cell culture samples.
- Participated in technology transfer activities and provided technical support to manufacturing teams. Implemented process improvements to increase operational efficiency.
- Handle SAP systems for efficient procurement and inventory management of raw materials and consumables.
- Authored and reviewed SOPs, batch records, and technical reports in compliance with regulatory standards for data integrity and traceability.
- Authored, reviewed, and revised SOPs, BMRs, and technical transfer documents to ensure end-to-end traceability and data integrity compliance.
- Conducted literature reviews to support research projects and maintain current knowledge of industry trends.
- Implemented corrective actions based on audit findings, resulting in improved QMS processes and procedures.
Senior scientific officer
Panacea biotec pvt ltd
05.2021 - 04.2022
- Executed TCID50 assays for viral potency evaluation of Sputnik V vaccine, contributing to quality assurance.
- Hands-on experience with adherent HEK 293 cells cultivation and scale-up in bioreactors for vaccine production.
- Proficient in cell culture techniques, including virus propagation, maintenance of cell lines, and aseptic handling.
- Conducted rtPCR for viral titer quantification and immunoplaque assays for Dengue vaccine testing, supporting vaccine efficacy assessments.
- Involved in protein estimation, ELISA, and related immunoassays for quality assessment.
- Maintained cGMP documentation, prepared and reviewed SOPs, ensuring regulatory compliance for quality control processes.
- Participated in validation studies related to cell culture processes.
Research Engineer, Cell culture lab
Advanced Microdevices Pvt. Ltd
12.2016 - 05.2021
- Maintained sterile conditions for cell line culture, ensuring viability and consistency.
- Optimized cell culture media and adapted adherent cells to suspension using design of experiments (DOE).
- Large scale production of mammalian cells using wave reactor.
- Utilized hybridoma technology for transfection of mammalian cells, leading to successful protein and antibody production (monoclonal and polyclonal).
- Worked on production of COVID-19 detection kit.
Education
B. Tech. - Biotechnology
Ambala College of Engineering and Applied Research
Mithapur, Ambala07-2016
Skills
Upstream process development
Mammalian cell culture
Bioreactor operation
Viral vector production
Process optimization
GMP compliance
SOP authoring
Batch record review
Technology transfer
Microsoft Office tools
Timeline
Assistant Manager (Team Lead) Upstream Biologics
Kwality Pharma Limited
12.2025 - Current
Assistant Manager AAV/LV USP
MicroCrispr Pvt Ltd, Meril
05.2025 - 11.2025
Research Associate, Upstream Processing
Zydus Research Centre
04.2022 - 05.2025
Senior scientific officer
Panacea biotec pvt ltd
05.2021 - 04.2022
Research Engineer, Cell culture lab
Advanced Microdevices Pvt. Ltd
12.2016 - 05.2021
B. Tech. - Biotechnology
Ambala College of Engineering and Applied Research