Nancy Sullivan Email & Phone Number

Princeton, NJ

• Directed the commercial and development raw material and product stability programs and provided protocols, reports and statistical analyses.
• Managed commercial products reference standards programs and domestic clinical supplies programs.
• Designed transportation test protocols based on IAEA, PDA and ISTA guidelines.
• Attended FDA teleconferences as the stability/documentation SME and provided technical data packages.
• Compiled CMC sections of NDA, IND and SNDA’s for Regulatory and FDA submissions.
• Reviewed documentation for technology transfer to analytical and manufacturing contract vendors.

New Brunswick, NJ

• Coordinated stability studies for diagnostic agents and raw materials used in the manufacture of these products.
• Followed protocols, obtains and compiled data by interaction with QC and Analytical R & D and issued research reports including statistical analyses.
• Wrote SOP and stability protocols and compiled data needed for Regulatory and the FDA.
• Prepared log sheets and reviewed manufacturing records for the approval of clinical, stability and toxicology supplies.
• Coordinated the labeling, shipment and return of clinical supplies and maintain records.
• Supervision of professionals and operations in the stability group.

New Brunswick, NJ

• Prepared diagnostic agents for clinical and stability studies.
• Conducted experiments directed towards reformulating proposed and existing diagnostic agents.
• Gained familiarity with Standard Operating Procedures (SOP) for Good Manufacturing Practices (GMP) for the sterile and prep areas.
• Developed analytical methods and performed pharmaceutical analysis of drug substances and dosage forms using HPLC.
• Supervised technical personnel involved in performing method development and routine HPLC assays.
• Familiar with Perkin-Elmer LIMS and Hewlett Packard 3357 Lab Automation System.

Somerville, NJ

• Research and development of new and existing positive photoresist products.
• Projects included improved thermal stability of resist and novel sensitizer evaluations using the laser interferometry method.
• Handled formulations of resist samples for field testing and customer requests within set time limits.

Masters, Chemistry

Bachelor Of Arts (B.A.), Biochemistry