David Slifer Email & Phone Number

Philadelphia, PA, US

Conshohocken, PA

* Performed process engineering design for a sterile cartridge facility capable of producing 36,000 units per hour.* Designed a 5 stage homogenization process which produces 24MM vials of an emulsion product annually.* Conducted hydraulic calculations for utility systems such as clean steam, process air and water for injection.* Prepared capacity analysis.

Managed development projects leading to the manufacture of GLP and clinical supplies for client-based Phase I & II studies. Participated in interdepartmental planning meetings.

• Designed and executed formulation and process scale-up studies to support development of solid and liq-uid nanoparticulate dosage forms intended for oral and parenteral administration.
• Utilized design of experiments to identify the critical parameters of existing processing equip-ment which decreased manufacturing times up to 50%.
• Coordinated the sterile manufacture, packaging and shipment of a clinical supply between 3 sites located in 3 different states by developing and implementing an in-depth process flow diagram.
• Facilitated the technology transfer of a sterile formulation and process to a client by designing novel sterilization containers, preparing study reports and conducting validation experiments, providing royalty.

• Supported the commercial process development of nanoparticulate dispersions by planning and conduct-ing design of experiment studies, including critical parameters optimization.
• Developed and scaled-up successful nanoparticle processes for two commercially marketed prod-ucts (TriCor, MegAce ES) which had combined sales in excess of $1.6 billion in 2010.
• Expanded capability of pilot scale equipment by conducting experiments designed to push the operating limitations, increasing the maximum operating speed by 33%.

* Performed analytical testing in support of: analytical method development and validation, formulation and process development projects, GLP toxicology supplies, in-process and release testing of clinical supplies. Planned, designed and executed analytical methods in support of process development and formulation development projects; generated.

* Performed release and stability testing of various levels of pharmaceutical drug products and raw materials, primarily by HPLC.* Coordinated all drug stability operations including protocol design and execution, inventory control, and stability chamber maintenance.

M.S., Chemical Engineering

Concentration in Biochemical Engineering

B.S., Chemical Engineering

Minor - Economics