Craig Oakum

Manager, Analytical Laboratory Services at Experic
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Contact Information
us****@****om
(386) 825-5501
Location
JE

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Eugene (Gene) Reynolds

I have had the pleasure of working directly with Craig for over 10 years. In that time he has grown from a capable scientist, to a lead aerosol scientist, and now to a group leader. Craig has played an integral role in the development of the MicroDose active inhaler technology, developing novel testing techniques for a breath-activated DPI, including in vitro simulation of tidal breathing and its effect on aerosol performance, including face mask deposition. Craig has a "can do" attitude, is an effective technical leader and motivator, and is able to manage complex logistics to ensure that projects get done. He has done a very good job at managing infrastructure issues (metrology, reference standards, etc.) at both a small company (MicroDose) and at a small site within a large company (Teva). He is a dedicated, hard-working individual and leads by example. He would be a valuable technical contributor and manager within any R&D organization.

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Experience

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager, Analytical Laboratory Services
      • May 2021 - Present

    • Quality Control Manager
      • Jan 2019 - May 2021

    • Sports and Recreation Instruction
    • Analytical R&D Group Leader
      • Sep 2007 - Aug 2018

      Formerly MicroDose Therapeutx Jul 2012–Aug 2018 Analytical R&D Group Leader / Supervisor, Teva Pharmaceuticals (Formerly MicroDose Therapeutx) Team leader for analytical development of drug/device combination products. Oversee lab activities to ensure that experiments are properly executed to ensure accuracy and validity. • Interfaced with project management to align weekly goals and lab schedule in development of a Phase 1/Phase 2 ready inhaler. • Authored SOP’s and CAPA’s that resulted in ISO certification. • Spearhead lab operations by ensuring that support activities are completed in a timely manner. • Author and maintain Microsoft Access databases for laboratory activities including metrology, reference standards, drug product development, equipment use, and lab safety labels that that streamlined lab operations for efficiency. Sep 2007–Jul 2012 Scientist II, MicroDose Therapeutx Lead scientist on feasibility studies for investigational new drug applications in proprietary Phase 1/Phase 2 dry powder inhaler technology. • Characterized pharmaceutical development projects for aerodynamic particle size distribution via Next Generation Impactor (NGI), delivered dose uniformity, and simulated breathing studies. • Optimized design of single-dose and multi-dose dry powder inhaler with engineering team through design of experiment (DOE) studies that enabled in several clinical trials. • Developed a simulated clinical dosing system to measure effects of breathing through a dry powder inhaler that resulted in adjustments to the inhaler’s design reducing negative effects on performance. • Trained clinical staff on use of proprietary dry powder inhaler and attended multiple clinical trials as technical support to ensure successful execution with new Phase 1 inhaler technology. • Crafted study materials for clinical trials including drug, user instruction manuals, and supplies. • Authored SOPs and Equipment Procedures for analytical methods used in studies.

    • United Kingdom
    • Retail
    • Quality Lab Associate I
      • Jan 2002 - Aug 2007

      QC Chemist for sterile injectable manufacturing Performed quality tests on finished sterile injectable product, commercial stability, validation, and raw material samples. Tests included assays for active pharmaceutical ingredients, related substances and preservatives by HPLC or GC, oxygen headspace testing by GC, identification by thin layer chromatography, infrared analysis or UV/Vis spectrometry, trace metal presence by atomic absorbance, pH and osmolality measurement, various titration assays, and other miscellaneous tests. • Maintained reference standards (physical and database inventories) as necessary and performed cost analysis that resulted in reduced consumption and increased savings. • Conducted laboratory investigation protocol testing. • Wrote SOPs and test methods and trained other chemists on changes and new procedures and techniques. • Monitored work from other shifts and performed troubleshooting of software and instruments as necessary.

Education

  • Elizabethtown College
    B.S., Biochemistry

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