Analytical Research & Development Sr. Supervisor

 Analytical Research & Development Sr. Supervisor for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Independently perf daily asgmts following org’s policies + procedures, + state, fed + local laws. Design practical rsrch expts based on lit., vendor DMF, + FDA guidance to support pjct directives. Perf + hold others accountable to dev methods to test raw materials, IP, FP + ST samples using HPLC, Gas Chromatography (GC), UV/Vis, automatic titrator, IR, AA and TLC + dissolution apparatus. Provide recs to Prod Dvlpmnt based on dissolution testing + phys characterization of Company + competitor prods. Troubleshoot existing test methods + procedures. Assess jr staff members re sci + tech capabilities. Work w/ mngmnt to set priorities + reach objectives. Ensure analytical procedures align w/ current compendial + FDA guidance. Introduce new analyt techniques to lab. Operate gen analytical instruments during raw material, in process + finished product release + stability testing. Perf wet chemistry tests. Prep standard + sample sols, + perf calculations associated w/test analyses. May involve extended periods of standing and lifting up to 30 pounds. May undergo background checks and drug screening.  

 Must have Bach in Analytical Chem, Chem, or rel field, 4 yrs rel exp working in analytical lab in pharmaceutical industry, and required skills. In the alternate, must have Masters in Analytical Chem, Chem, or rel field, 3 yrs rel exp working in analytical lab in pharmaceutical industry, and required skills. Required skills: (3 yrs exp) in: operation and interpretation of data generated from usage of analytical instruments such as HPLC, LC/MS, GC/MS, NMR, FTIR, and ICP-MS; preparation, extraction, purification of Wet Chemistry testing samples; SOPs related to pharmaceutical laboratory testing, analyses, and documentation; UV/IR, HPLC, GC, TLC, and dissolution testing instruments operations, methods, and techniques; following FDA, cGLP, cGMP, and SOP regulatory rules, regulations, and guidelines; advanced chemistry, pharmaceutical and statistical theories, methods and procedures; calibration and troubleshooting LC/MS, GC/MS, and ICP-MS, GFAA, NMR in testing and characterization of organic and inorganic compounds; responding to regulatory agency inquires; training and mentoring junior staff, including coordinating and reviewing work; technical report writing; and ensuring compliance with internal policies and procedures.  Any suitable combination of education, training, or experience is acceptable.