ATEET RATHI
Summary
Results-driven Bioprocess Manufacturing Professional with 5 years of experience in vaccine, biosimilar, and monoclonal antibody production in GMP environments. Expertise in upstream manufacturing, cell culture operations, scale-up processes, and technology transfer. Proficient with Cytiva, Sartorius, PALL, ABEC, and Wave bioreactor platforms from 50L to 6000L, facilitating collaboration across manufacturing, engineering, quality assurance, and regulatory teams.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Executive
KASHIV BIOSCIENCES LLC
Ahmedabad
12.2024 - Current
- Support process scale-up, technology transfer, equipment qualification, and commercial manufacturing activities.
- Facilitated process scale-up from R&D and pilot-scale operations to 50L and 200L single-use bioreactor platforms, enhancing production capabilities.
- Supported successful scale-up to a 2000L single-use bioreactor platform.
- Successfully supported execution and completion of a 2000L engineering batch.
- Collaborated with Process Development, Manufacturing, Quality Assurance, Engineering, and Validation teams during technology transfer and manufacturing readiness activities.
- Coordinated upstream equipment qualification, commissioning, and manufacturing readiness activities to ensure operational efficiency.
- Participated in project meetings and Technology Transfer of 2KL PPQ batches during international assignment in Piscataway, New Jersey.
- Executed batch operations, resolved troubleshooting issues, and reviewed documentation to maintain GMP compliance.
Executive – Cell Culture Production
INTAS PHARMACEUTICALS LTD.
02.2023 - 12.2024
- Operated 2000L single-use bioreactors (Cytiva and Sartorius) during commercial manufacturing campaigns.
- Participated in manufacturing of monoclonal antibodies and biosimilar drug substances at both commercial and engineering scale, contributing to successful product delivery.
- Executed media and harvest preparation, and conducted depth filtration operations to ensure optimal cell culture outcomes.
- Operated shake flask systems (SF125 to SF3000) for cell culture scale-up activities.
- Supported operations and troubleshooting of Cytiva and Sartorius bioreactor systems to maintain production efficiency.
- Performed single-use bag installation, assembly preparation, and integrity testing.
- Conducted SIP and CIP of vessels and transfer lines to ensure equipment readiness.
- Maintained GMP documentation and adherence to manufacturing procedures.
- Received a Spot Award for contributions to audit preparation and process improvement initiatives.
Production Officer – Vaccine Manufacturing
SERUM INSTITUTE OF INDIA PVT. LTD.
11.2021 - 01.2023
- Contributed to Covishield vaccine manufacturing supporting approximately 1.6 billion doses.
- Assisted in novavax vaccine manufacturing, facilitating seamless operations and supporting production targets.
- Operated wave bioreactors (50L–200L) and supported large-scale manufacturing in 4000L and 6000L single-use bioreactors.
- Managed media preparation, single-use assemblies, biowelder/bioseal operations, and process support activities.
- Prepared and reviewed batch manufacturing records (BMRs) to ensure compliance and accuracy.
- Developed and revised SOPs and process protocols.
- Conducted risk assessments and managed change control documentation.
- Performed cell counting, microscopy, sampling, filter integrity testing, equipment cleaning, and maintenance activities.
- Received a Letter of Appreciation from the CEO for contributions during inspections by: US FDA, MHRA (United Kingdom), TGA (Australia), Health Canada.
Trainee Production Officer
SERUM INSTITUTE OF INDIA PVT. LTD.
11.2020 - 10.2021
- Facilitated fermentation process development activities to enhance yield and quality.
- Contributed to equipment and process qualification to ensure operational readiness.
- Utilized EDMS, CMMS, and QMS systems to maintain compliance with GLP and GDP standards.
Production Intern
SERUM INSTITUTE OF INDIA PVT. LTD.
07.2018 - 07.2018
- Operated production machinery to support vaccine manufacturing processes.
- Supported bacterial vaccine manufacturing operations through hands-on involvement.
- Contributed to Quality Control activities and manufacturing support functions to ensure compliance and product integrity.
- Assisted in quality control checks to ensure product safety standards.
- Maintained cleanliness and organization of workstations for efficient operations.
Education
Bachelor of Technology - Biotechnology
Savitribai Phule Pune University
Pune01-2019
Skills
- Upstream & Bioprocessing
- Bioreactor Platforms
- Single-Use Bioreactors (50L, 200L, 2000L, 4000L, 6000L)
- Cell Culture Handling
- Process Scale-Up
- Media Preparation
- Harvest Operations
- Depth Filtration
- Single-use technology-Bag customization and process assembly ports preparation and Design
- Cytiva- (Xcellerex)Bioreactors 200L & 2000L
- Sartorius-Skilled in the operation and monitoring of Sartorius upstream bioprocess equipments
- PALL-Bioreactors
- ABEC-4KL & 6KL STR Bioreactors
- Wave Bioreactors
- Equipment Qualification
- Process Qualification
- GMP & Compliance
- SOP Management
- BMR Documentation
- Audit Preparation
- Risk Assessment
- Change Control
- Software and Systems
- EDMS
- CMMS
- Microsoft Excel
- Microsoft Word
- Separation Techniques
- Centrifuge
- Autoclaves
- LN2 Systems
- Deep Freezers
- Shaker Incubators, Flasks and Biosafety operation
- Single-Use Mixers, Holders
- Biowelder
- Bioseal
- Equipment
- Shaker Incubators, Flasks and Biosafety operation
Projects
- Contributed to Covishield vaccine manufacturing supporting approximately 1.6 billion doses.
- Supported Novavax vaccine manufacturing operations.
- Received a Letter of Appreciation from the CEO for contributions during inspections by:, US FDA, MHRA (United Kingdom), TGA (Australia), Health Canada.
- Participated in project meetings and supported onsite Technology Transfer activities for 2 KL PPQ batches during an international assignment in Piscataway Plant, New Jersey, USA.
PROFESSIONAL HIGHLIGHTS
- Contributed to Covishield vaccine production, supporting approximately 1.6 billion doses.
- Supported process scale-up from pilot-scale operations to 50L, 200L, and 2000L single-use bioreactor platforms.
- Selected for an international assignment in Piscataway, New Jersey, USA, supporting technology transfer and scale-up activities.
- Successfully supported execution and completion of a 2000L engineering batch.
- Hands-on experience with Cytiva, Sartorius, PALL, ABEC, and Wave bioreactor systems.
- Strong background in equipment qualification, manufacturing operations, and cross-functional collaboration.
- Received Letter of Appreciation from the CEO of Serum Institute of India for contributions during regulatory audit preparedness.
- Received Spot Award at Intas Pharmaceuticals for audit readiness and process improvement initiatives.
Websites
Certification
- Chromatographic Techniques for Characterisation of Biotherapeutics, Venture Center, Pune | June 2020
- Recent Trends in Food and Agri-Biotechnology, DBT Sponsored Program | July 2017
Extracurricular Activities
Theatre & Performing Arts Member of a national award-winning theatre/street play team at IIT Bombay Mood indigo . Winner of 23 inter-collegiate drama competitions. Content Creation & Actor/ writer @The Reatables -You tube channel .
Languages
- Hindi
- Marathi
- Gujarati
- Marwari
- English (IELTS: 6.5/9)
Timeline
Senior Executive
KASHIV BIOSCIENCES LLC
12.2024 - Current
Executive – Cell Culture Production
INTAS PHARMACEUTICALS LTD.
02.2023 - 12.2024
Production Officer – Vaccine Manufacturing
SERUM INSTITUTE OF INDIA PVT. LTD.
11.2021 - 01.2023
Trainee Production Officer
SERUM INSTITUTE OF INDIA PVT. LTD.
11.2020 - 10.2021
Production Intern
SERUM INSTITUTE OF INDIA PVT. LTD.
07.2018 - 07.2018
Bachelor of Technology - Biotechnology
Savitribai Phule Pune University