Sravanthi Bakka

Biopharmaceutical professional with 8+ years of experience seeking a career transition into Regulatory Affairs and Clinical Research. Eager to leverage expertise in pharmaceutical manufacturing, compliance, quality systems, documentation, and drug development to contribute to regulatory and clinical operations.

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.

M.Tech - Biotechnology - JNTU

M.Sc - Biochemistry - Nagarjuna University