Kim Sobien

About Kim Sobien

I am a Senior Microbiology Consultant with 25+ years of experience in pharmaceutical microbiology, radiopharmaceutical microbiology and process development, contamination control, sterility assurance, quality assurance, quality control, regulatory compliance, investigations/deviations, process improvement, and aseptic behavior observation and coaching. Over my career, I have worked with a variety of drug manufacturing categories, including sterile fill and finish drug product, drug substance, radiopharmaceuticals / theranostics, biologics, and vaccines. As a recognized leader and expert in my field, I have contributed to the advancement of pharmaceutical microbiology through my involvement with the Parenteral Drug Association (PDA), the leading global organization for science, technology, and regulatory information. I am currently Co-Lead for the PDA Microbiology/Environmental Monitoring Interest Group, President-Elect (20••••26) for the PDA Southeast Chapter, Co-Lead for the 2026 PDA Workshop on Microbial Data Deviation Investigations, Co-Lead for the PDA TR67 writing team, instructor for a PDA course on microbiology deviations, have served on the planning committee and as the Industry Co-Chair for the PDA Conference on Pharmaceutical Microbiology, as a member of the PDA Microbial Data Deviation Technical Report Team (TR88), and an author and speaker on various topics related to microbiology and sterility assurance. I am passionate about sharing my knowledge and experience with the industry and helping clients achieve their quality and compliance goals.

Experience

1. Senior Consultant - Microbiology

   ValSource Inc.

   Apr 2023 — Present · Raleigh, NC, US

Education

• University of Wisconsin-La Crosse

  BS, Microbiology

  1993 — 1998

• University of Phoenix

  MS, Masters of Business Administration

  2005 — 2007