- Operate and troubleshoot instruments including HPLC/UPLC, Dissolution, Karl-Fischer, GC, FTIR, UV- Follow test methods and protocols, and SOP’s- Document all results in notebook per GMP- Peer review notebooks- Comply to all regulatory agencies including FDA, EPA, OSHA and DEA

- Manage daily activities of research lab including scheduling, data analysis and review, supervising chemists, ordering supplies and instrumentation, report generation to support ANDA's, and method qualification- Sourced API's and impurities to support research projects- Worked closely with formulators to ensure proper analytical support

- Developed and maintained all documents and specifications for Continuous Extrusion and Molded board lines- Led small team of technicians in all aspects of physical testing and blending materials for manufacturing.- Maintained physical inventory and released all incoming and outgoing products and raw materials.- Documented all daily manufactured products and kept thorough inventory of production.

- Taught environmental science classes to undergraduate students.

- Performed acid digestion and analyzed samples for FeO and Fe2O3 using colometric assay. Prepared raw material samples for XRAY detection. Performed analysis of moisture, LOI, and prepared samples for Flourine analyzer using acid digestion then analyzed using Metrohm instrument. - Led Safety Team for department. Performed monthly safety walk-throughs and organize presentations for monthly meetings.

Performed all analytical functions to support formulation and feasibility studies for novel, polymer-based drug delivery system including content, dissolution, and bio-analytical assays.

Developed and validated methodology for finished transdermal systems, including HPLC, Headspace/GC/FID, and dissolution testing. Optimized existing methods through method improvements.- Supervised 2-3 lower-level scientists in the execution of validation protocols and general training on method development.- Performed all other supervisory duties including performance evaluations, scheduling of projects, and department budgeting.- Wrote validation protocols, final validation reports, SOP's, test methods, and research reports. Assisted in writing CMC section of NDA.

- Developed and validated methods for determinations of drug levels in plasma and serum samples, using various extraction methods and analyzing the samples using HPLC and GC/MS techniques.- Wrote protocols for validation and summary reports after completion of validation.- Supervised Laboratory Technicians in scheduling and completion of bio-analytical studies. Wrote final data summaries.- Assisted in writing the CMC section of two IND’s.- Performed routine analysis of finished pharmaceutical product to determine content and uniformity, using HPLC methodology.- Wrote SOP's, test methods, and validation reports.