Senior Executive – Medical Science - Virchow Biotech Pvt. Ltd - Hyderabad, TS, India
(2023-06 - 2024-05)
Product: - mAbs
- Preparing the regulatory submission documentation for mAb's production.
- Involved in QMS activities.
- Determined potency of antibodies using cell-based assays.
Associate – Medical Science - Sanofi Healthcare India Pvt. Ltd - Hyderabad, TS, India
(2022-06 - 2023-02)
Product: - Hepatitis-A
- Executed and oversaw cell culture activities to ensure efficient propagation of MRC-5 cells.
- Reviewed documents and checklists, verifying compliance with GDP and cGMP throughout process execution.
- Facilitated the implementation of cGMP practices, 5S, and actively participated in investigations.
- Maintained on-time calibration, validation, and requalification of equipment and production areas.
- Procured necessary materials and consumables while monitoring SAP stock availability and replenishing as needed.
- Managed material readiness as per the schedule for cell culture manufacturing activities.
- Collaborated and provided support during facility PQ & RQ and monitored daily progress of scheduled activities and ensured completion.
- Created SOP, BMR, and JD for employees, and devised individual training plans to ensure thorough training.
- Reviewed batch manufacturing records and promptly submitted them to the quality system.
- Conducted practical and theoretical training for new joiners on the cell culture process.
Senior Technical Officer - Pharma - Brilliant Bio Pharma Pvt. Ltd. - Hyderabad, TS, India
(2008-09 - 2021-05)
Product: - Foot and Mouth Disease (FMD) Vaccines and Rabies disease
- Performed effective cell culture operations and contributed to virus culture and virus inactivation.
- Organized and scheduled daily activities for the production process.
- Supervised the CIP and SIP processes of bioreactors.
- Coordinated regularly with respective departments for equipment validation and calibration.
- Maintained production facility in compliance with cGMP standards with GDP.
- Conducted training for new technicians.
- managed a team of ten members and ensured accuracy and efficiency in all activities.
