Supriya Ragavendran

Project: Novo Nordisk, Hillerød

• Review of Risk Assessments, P&IDs, Functional Specifications with respect to Science and Risk based Validation approach.
• Wrote, reviewed and edited Commissioning as well as validation protocols and test scripts related to upstream equipments such as Bioreactors, Media Preparation Vessels etc in TIMS in accordance with template requirements.
• Developed positive working relationships with stakeholders to effectively coordinate work activities.

Products: Trastuzumab and Bevacizumab

• Experienced in the production of MAbs from CHO-s cell lines
• Execution of Upstream manufacturing activities.
• Handling BOM creation, Batch management activities in SAP.
• SOP, BMR, and qualification protocol preparations and executions.
• Handling QMS elements, such as Risk assessment Change control and deviations.
• Developed Cost reduction procedure for additional media filtration.
• Awarded with Rising star and Achiever awards.

Senior Executive-Biologicals Upstream research & development

Projects:

• Optimization of productivity for Lipase from Pichia pastoris.
• Production of GCSF from Escherichia coli BL21 strain.
• Production of menaquinone 7 from Bacillus subtilis.

Senior Executive-Biologicals Upstream manufacturing

Products: Collagenase enzyme (CCH) bulk drug substance for Endo pharmaceutical.INC,USA.

• Experienced in Collagenase enzyme production derived from Clostridium histolyticum.
• Execution of upstream manufacturing activities such as: Inoculum propagation, fermentation, Media and buffer preparation, and harvest broth clarification.
• Involved in the R and D development batch and process validation batches for Collagenase DS production.
• Performed process support validation studies such as KLa determination, mixing study, SIP cycle development study, and OD bias study of correction factor determination for the spectrophotometer.
• CIP and SIP for fermenter and process vessels, handling of POD and Mustang Q filtration systems.
• SOP, BMR, and Qualification protocol preparations and Execution
• Handling QMS elements such as deviation, incident, and change control.
• Conducted training sessions related to upstream documents for fellow colleagues.
• Equipment Qualifications (DQ, IQ, OQ, PQ): Fermenter, Media Preparation Vessels, Biosafety Cabinets, Shaker Incubator, LAF
• extended support for Implementation of SAP PP Module: Master Data creation, uploading & testing.
• Involved in the Operation and Performance Qualification of the SAP PP module.