Mrudang Shah
Senior Qualification Engineer @Nkarta, Inc
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WORK HISTORY
Senior Qualification Engineer @Nkarta, Inc
South San Francisco, CA, US
Development of vendor as well as internal qualification documents for manufacturing and QC equipment. Execution of qualification documents as well as deviation reporting. Generation of summary reports from qualifications.
EDUCATION
Shardamandir Vinaymandir
High School Diploma, Science
Sardar Patel University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
Keck Graduate Institute
Professional Master's, Bioscience Business & Bioprocessing
Wayne State University
Ph.D., Pharmaceutical Sciences
ABOUT MRUDANG SHAH
Cross-Functional Technical Project Manager and Qualification Engineer with 10+ years of experience in the fields of Biotechnology, Cell/Gene Therapy and Pharmaceutical Sciences. I have expertise in equipment design and engineering as well as Manufacturing and Quality Control areas. I help companies realize their vision by efficient delivery of technical projects. Some examples include: 1. As a Technical Project Manager, I enabled the delivery of QC laboratory with qualified equipment for a gene therapy client to transfer mature QC methods from analytical development to the QC laboratory. As a Technical Project Manager, I transitioned into a project with existing conflict due to budget constraints. I helped identify the root cause of conflict to ensure the realization of project goals in a timely manner. This enabled timely release of manufacturing suite for Drug Product formulation, filling and packaging for an advanced surgery therapeutic client. As a Drug Product and Packaging Engineer, I managed the outsourcing of drug product as well as packaging aspects for commercial products. In addition, I oversaw the mechanical shipping qualification as well as Product Quality Impact testing for newly engineerd container-closure systems for commercial therapeutics. I participated as a technical lead to evaluate potential of using ocean shipping route as a method for commercial therapeutic shipping to reduce carbon footprint. The client is a global biotech company. As a Qualification Engineer, I was involved in a project that started with proof-of-concept design of the equipment. I participated in design optimization by Factory and Site Acceptance Testing. I was also involved in the Qualification of an integrated equipment to enable client to perform packaging and serialization of fill-finished drug product. I get excited about opportunities to deliver on high value projects to serve patients in the areas of highly unmet needs. I am looking for roles that involve management as well as hands-on delivery of high value projects. I love exploring collaboration opportunities to develop symbiotic relationships. Please reach out to me at m••••••••@gmail.com
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