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Jeff Zadrozny, PMP

Jeff Zadrozny, PMP

Process Development Chemist

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  • Timeline

  • About me

    Senior Project Manager at Roeslein & Associates

  • Education

    • Colorado State University

      -
      Bachelor of Science Biochemistry

      Graduate Courses: • Bioprocess Purification (Colorado Bioprocess Center) • Drug Development, UCHSC School of Pharmaceutical SciencesAdditional Education:• Supply Chain Strategy and Management course, MIT Sloan School of Management

  • Experience

    • Hauser, Inc.

      Jan 1990 - Jan 1996
      Process Development Chemist

      Developed and optimized isolation and purification processes for GMP pharmaceuticals (Taxol) and herbal products.Performed early bench-top feasibility studies, pilot scale development and optimization, scale-up, and large-scale plant startup.Authored GMP documentation, SOPs and batch records.Developed, scaled-up, and started up a large-scale chromatographic process. Developed a critical automated on-line analytical system, involving HPLC and ELSD.Authored experimental results section of prospective validation that was approved by FDA. Show less

    • Sulzer Biologics, Inc.

      Jan 1996 - Jan 2001
      Process Development Engineer

      Installation, qualification and start-up of pilot scale equipment for purification of Transforming Growth Factor (TGF-B) family glycoproteins, under GMP compliance. Optimized protein purification process through bench-scale development studies, analytical method development and process data aquisition and control.

    • Proligo, Boulder CO.

      Jan 2001 - Jan 2002
      Manager, GMP Oligonucleotide Manufacturing

      Managed workforce and facility for contract manufacturing of pre-clinical, phase I and phase II oligonucleotide drugs.

    • Hauser Pharmaceutical Services, Denver CO.

      Sept 2002 - Feb 2008
      Project Manager, GMP Manufacturing (Senior Chemist)

      Project Manager for process development and manufacturing of multiple Phase I to Phase III APIs, dietary supplements and packaging products.Performed R&D, scale-up, plant construction management and start-up activities for a commercial GMP dietary supplement process.

    • Accera

      Feb 2008 - Feb 2015
      Director of Manufacturing

      Directed manufacturing program and GMP systems development leading to on-time national product launch of Axona, a medical food for the dietary management of Alzheimer’s disease.Manage development of multiple product formats for US and ex-US markets.Responsible for procurement, supply chain, MRP, logistics and finished product manufacturing. Composed CMC section of IND for Phase 2/3 study of AC-1204, accepted by FDAAccera was recognized as 2009 company of the year by the Colorado BioScience Association. Show less

    • Roeslein & Associates

      Feb 2015 - now
      Senior Project Manager

      Manage engineering, procurement, fabrication and installation projects for global customers in the (D&I) aluminum beverage can industry. Manage Renewable Natural Gas development, engineering, procurement, installation and start-up projects for Roeslein Alternative Energy

  • Licenses & Certifications

    • PMP

      Project Management Institute

    • CFS

      Institute of Food Technologists (IFT)
      Jan 2013