Kim Sobien

Kim Sobien Email and Phone Number

PDA Southeast Chapter President-Elect 2025-2026 @ PDA Southeast Chapter
Raleigh, NC, US
Kim Sobien's Location
Raleigh, North Carolina, United States, United States
Kim Sobien's Contact Details
About Kim Sobien

With over 25 years of experience in the pharmaceutical industry, I am a Senior Microbiology Consultant at ValSource Inc., a leading provider of consulting and validation services for the life sciences sector. My core competencies include pharmaceutical microbiology, contamination control, sterility assurance, quality assurance, quality control, regulatory compliance, investigations/deviations, radiopharmaceutical microbiology, process improvement, and aseptic behavior observation and coaching.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 EM/Microbiology Interest Group, President-Elect (2025-2026) for the PDA Southeast Chapter, Co-Lead for the TR67 writing team, 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.

Kim Sobien's Current Company Details
PDA Southeast Chapter

Pda Southeast Chapter

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PDA Southeast Chapter President-Elect 2025-2026
Raleigh, NC, US
Employees:
2
Kim Sobien Work Experience Details
  • Pda Southeast Chapter
    Pda Southeast Chapter President-Elect 2025-2026
    Pda Southeast Chapter
    Raleigh, Nc, Us
  • Valsource Inc.
    Senior Consultant - Microbiology
    Valsource Inc. Apr 2023 - Present
    Downingtown, Pennsylvania, Us
  • Pda Southeast Chapter
    Pda Southeast Chapter President-Elect 2025-2026
    Pda Southeast Chapter Nov 2024 - Present
  • Gsk
    Contamination Control Lead; Manufacturing, Science & Technology
    Gsk Nov 2021 - Apr 2023
    Brentford, Middlesex, Gb
  • Petnet Solutions, A Siemens Company
    Principal Sterility Assurance Engineer
    Petnet Solutions, A Siemens Company Mar 2017 - Oct 2021
  • Merck
    Associate Director, Regulatory Compliance
    Merck Aug 2015 - Mar 2017
    Rahway, New Jersey, Us
  • Bd Rx, A Wholly-Owned Subsidiary Of Bd (Becton, Dickinson And Company)
    Regulatory Compliance Lead
    Bd Rx, A Wholly-Owned Subsidiary Of Bd (Becton, Dickinson And Company) Jul 2013 - Jul 2015
    Franklin Lakes, New Jersey, Us
    Responsible for Regulatory Compliance for manufacturing of sterile injectable pre-filled syringe generic products.
  • Siemens Medical Solutions
    Quality Engineer 4 / Quality Assurance Compliance
    Siemens Medical Solutions Apr 2012 - Jul 2013
    Forchheim, De
    Radiopharmaceutical (Positron Emission Tomography - PET) Manufacturing at 47 production sites across the US. In-house and CMO product lines.
  • Oso Biopharmaceuticals Manufacturing, Llc
    Microbiology Laboratory Manager
    Oso Biopharmaceuticals Manufacturing, Llc Jan 2009 - Apr 2012
    Albuquerque, Nm, Us
    Microbiology laboratory at CMO - Aseptic fill & finish
  • Oso Biopharmaceuticals Manufacturing, Llc
    Microbiology Lab Supervisor
    Oso Biopharmaceuticals Manufacturing, Llc Jan 2007 - Dec 2009
    Albuquerque, Nm, Us
  • Catalent Pharma Solutions (Now Oso Biopharmaceuticals Mfg, Llc)
    Production Supervisor
    Catalent Pharma Solutions (Now Oso Biopharmaceuticals Mfg, Llc) Sep 2006 - Jan 2007
    Somerset, Nj, Us
  • Catalent Pharma Solutions (Now Oso Biopharmaceuticals Mfg, Llc)
    Lean Six Sigma Black Belt
    Catalent Pharma Solutions (Now Oso Biopharmaceuticals Mfg, Llc) May 2005 - Sep 2006
    Somerset, Nj, Us
  • Cardinal Health (Now Oso Biopharmaceuticals Mfg, Llc)
    Environmental Monitoring Coordinator
    Cardinal Health (Now Oso Biopharmaceuticals Mfg, Llc) Sep 2004 - Jun 2005
    Albuquerque, Nm, Us
  • Pierce Biotechnology (Now Fisherthermo Scientific)
    Quality Systems Specialist / Quality Control Chemist
    Pierce Biotechnology (Now Fisherthermo Scientific) Feb 1999 - Sep 2004

Kim Sobien Skills

Gmp Capa Fda Quality System Pharmaceutical Industry Validation Quality Assurance Biotechnology Aseptic Processing Sop Change Control Quality Control Microbiology 21 Cfr Part 11 Gxp Biopharmaceuticals Regulatory Affairs Manufacturing Quality Auditing Glp Regulatory Requirements Laboratory Environmental Monitoring Process Improvement Trackwise Root Cause Analysis Sterilization Six Sigma Continuous Improvement Cleaning Validation Process Simulation Standard Operating Procedure U.s. Food And Drug Administration Aseptic Technique Cgmp Usp Pharmaceuticals Lean Manufacturing Contract Manufacturing Quality Systems Auditing Qc Operational Excellence Compliance Good Laboratory Practice 5s Risk Assessment Contamination Control Process Development Fmea

Kim Sobien Education Details

  • University Of Wisconsin-La Crosse
    University Of Wisconsin-La Crosse
    Microbiology
  • University Of Phoenix
    University Of Phoenix
    Masters Of Business Administration

Frequently Asked Questions about Kim Sobien

What company does Kim Sobien work for?

Kim Sobien works for Pda Southeast Chapter

What is Kim Sobien's role at the current company?

Kim Sobien's current role is PDA Southeast Chapter President-Elect 2025-2026.

What is Kim Sobien's email address?

Kim Sobien's email address is ki****@****ail.com

What schools did Kim Sobien attend?

Kim Sobien attended University Of Wisconsin-La Crosse, University Of Phoenix.

What skills is Kim Sobien known for?

Kim Sobien has skills like Gmp, Capa, Fda, Quality System, Pharmaceutical Industry, Validation, Quality Assurance, Biotechnology, Aseptic Processing, Sop, Change Control, Quality Control.

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