Carin von Kahr
Associate Director, Msat @AskBio Inc.
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WORK HISTORY
Associate Director, Msat @AskBio Inc.
Durham, NC, US
Leads CMC MSAT function for gene therapy cardiac programs (Drug Substance and Drug Product), collaborating across teams to define and execute CMC strategy with external CDMO partners.Oversees all aspects of technology transfer for global clinical programs, guiding technical teams on overall strategy, scale-up, facility and manufacturing readiness to ensure supply continuity. Provides technical oversight and support to CDMO for Pilot and cGMP batch execution, including investigation leadership and person-in-plant activities.Contributes to shaping regulatory strategy for clinical programs, authoring documentation and serving as SME for agency interactions including briefing preparation, in addition to participating on the regulatory intelligence team.Manages and mentors organization of high caliber scientists and engineers to deliver organizational goals and actualize robust process control strategies for the manufacture of gene therapy products.
EDUCATION
Colorado State University
M.S., Chemical Engineering
North Carolina State University
Bachelor of Science, Chemical Engineering
North Carolina State University
B.S., Chemical Engineering
ABOUT CARIN VON KAHR
Accomplished pharmaceutical and biotechnology leader with 20 years of expertise in process development, manufacturing sciences, and process engineering organizations. Proven success in technology transfer from small-scale processes through scale-up, facility fit, operational readiness, and execution of complex manufacturing campaigns across early-phase clinical through commercialization, including New Product Introduction (NPI) and Process Performance Qualification (PPQ). Skilled in technical project management, strategic planning, alliance (CDMO) oversight, and managing partnerships, with a record of driving operational success through building robust business processes and clear partnership frameworks. Adept at leading global CMC teams to achieve product realization with robust process control strategies and regulatory submissions (BLA) to support successful agency inspections. Recognized for fostering collaboration across international teams, aligning stakeholders understanding and ways of working to ensure quality, compliance, and risk reduction — consistently delivering innovative therapies from development through commercialization.
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