Akanksha Kala
Scientist at Gilead Sciences I Bio Global MSAT I Commercial Biologics Technical Operations
- Role
- Scientist at Gilead Sciences
- Location
- San Mateo, CA, US
- LinkedIn followers
- 500 followers
Experience
Scientist
Aug 2023 — Present · Foster City, CA, US
Deeply involved in Commercial technology transfer activities (downstream and upstream) for biopharmaceutical drug substance with a strong focus on downstream - Contribute to project work streams such as facility fits, gap and risk assessments, process validation, control strategy development, continued process verification, change management-Serve as key downstream representative working with Contract manufacturing organizations to establish commercial manufacturing process for Gilead products -Author and review reports, protocols and master batch records that are compliant with contemporaneous regulatory guidelines for engineering, PPQ and CPV campaigns -Contribute to regulatory BLA filings in support of launch and expansion of Gilead products through authorship of MSAT sections -Work cross functionally on investigating and addressing complex deviations during program campaigns and contributing to technical CAPAs -Collaborate with process development groups to support process characterization and establishment of design space to support commercial tech transfer and validation -Participate in Person in Plant (PIP) activities in GMP manufacturing sites to serve as lead downstream Subject matter expert during batch execution
Education
Drexel University
Master's degree, Chemical Engineering
2017 — 2019
Ramaiah Institute Of Technology
Bachelor of Engineering - BE, Chemical Engineering
2013 — 2017
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