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. • Maintained compliant department documentation programs including SOP’s & protocols. • Managed department environmental storage monitoring program. • Reviewed and approved company-wide SOP’s. • Knowledge of cGMP’s, FDA and ICH stability guidelines. • Certified in DOT Hazardous Material and IATA Dangerous Goods shipments.

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