Ron Frank Email & Phone Number

• Strong background in cGMP, OSHA, FDA, DEA and GLP regulations and guidelines• Experience in drafting and reviewing a variety of cGMP documentation including deviations, batch records, SOP’s, equipment validations (IQ/OQ/PQ) and supporting documents for manufacturing process validation.• Facilities management as it pertains to construction projects both new and renovation of existing facilities to ensure equipment and systems are built to specification prior to going online.• Experience with a wide variety of pilot plant equipment including Delta V automated process control software, Allen Bradley PLC process controls, Factory Talk process control software, pressure filters, agitated filter dryers, glove boxes, heat transfer systems, wiped film evaporators, large scale chromatography columns, sparkler filters, centri-sifters, hammer mills, co mills, tray dryers, cone dryers and centrifuges.• Highly regarded member of cross-functional teams (Analytical, Quality Control, Regulatory Affairs, Quality Assurance, EH&S, Kilo Lab manufacturing and Process Development) to ensure safe and effective process transfer from R&D to pilot scale manufacturing.• Extensive knowledge on safely handling and manufacturing highly potent active pharmaceutical ingredients (HPAPI’s).• Proficient computer skills-Word, Excel, Power Point, Project, ChemDraw, ELN, Beilstein, PHA works, PHA Pro and a variety of other programs and databases.• Process Hazard Analysis including P&ID interpretation, material balance, material of construction, equipment limitations and chemical compatibility considerations.

Listed skills include Gmp, Pharmaceutical Industry, Fda, P&Id, and 24 others.

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  University Of Wisconsin-Stevens Point

  Chemistry