Len is a senior consultant with over twenty-nine years of parenteral product development experience in the pharmaceutical and biotechnology industry as well extensive advanced trainer skills.
Len has an extensive background in product/process development, freeze-drying, cleanroom aseptic operations and cGMPs. Len’s pharmaceutical experience includes Clinical Trial Manufacturing, lyophilization (freeze-dry) cycle development, parenteral/solid dose product development, metered dose inhalers, as well as several process/facility start-ups. His major pharmaceutical company experience includes Novartis, IMA Life NA, Cardinal Health, Glaxo SmithKline, Bristol Meyers-Squib, and Praxis Biologics (now Pfizer Vaccines). Prior to working at Novartis, Len was working for the State of North Carolina assisting in the design and start-up of the Biomanufacturing Training and Education Center (BTEC) on Centennial Campus. He developed several Aseptic Operation training programs for the Pharmaceutical industry and the FDA. Len holds a Master of Science in Microbiology/Immunochemistry from the State University of New York and Upstate Medical Center.
Examples of projects completed:
Assisted in the design, construction, start-up of a new Clinical Trial Manufacturing Facility with syringe filling, vial filling and Lyophilization (freeze-dry) capabilities, managed operational activities
Assisted in design, construction and start-up of a Development Laboratory and Clean Room for Pharmaceutical freeze-dry applications; specified all process equipment and analytical support instrumentation, Developed custom lyophilization process parameters for client Pharmaceutical products
Assisted in design, construction and start-up of a new 90,000 ft2 Biomanufacturing Training and Education Center (BTEC) facility which includes a 10,000 ft2 cleanroom.
Successfully designed and delivered annual training programs for FDA inspectors using online courses, synchronous interactive webinars (Elluminate ®, WhiteBoard ®) and 3-day on-site hands-on laboratory training experiments.
Assisted in design, construction and start-up of a new regulatory-compliant Pilot Plant facility for the manufacture of Metered Dose Inhalers (MDI’s) for human use; Responsible for planning, implementing and delivery of clinical manufacturing supplies and services
Team leader for multi-disciplinary intra-company groups and external support companies; successful communication with a wide variety of people including engineers, scientists, vendors, contractors and FDA & European Regulatory Authorities.
Managed Aseptic Cleanroom Suite operations; developed, manufactured and delivered Clinical Trial Material products for investigating new drugs including parenteral (injectable, nasal spray), freeze-dried, solid-dose, DEA-controlled drugs, biopharmaceuticals and vaccines; scale-up and transfer to production facilities worldwide