Analytical Scientist II Job

Develop and validate new analytical methods, support formulation studies and perform analytical testing to support regulatory submissions which may include: Instrumental analysis such as HPLC, GC, UV, ICP-MS, LC-MS, GC-MS and FTIR as well as wet chemistry such as titrations, LOD and chemical identification tests; Develop analytical methods based on HPLC, GC, GC/MS LC/MS and ICP/MS following scientific approach; Complete method development and validation in a timely manner to support new product development and ANDA submissions; Perform analytical testing of raw materials, finished product, and components including wet chemistry and analytical chemistry techniques; Support change in project priorities and be able to adapt to fast paced working environment; Perform routine maintenance of analytical instruments; Provide analytical support to formulation group in order to finalize the formulation composition and components for new products; Prepare standard volumetric solutions and reagents used in testing; Perform critical interpretation of analytical data; Execution of mathematical calculations as outlined in test methods; Assess data to determine if the material tested meets its specifications; Peer review and approval of raw data; Write and review SOPs, Validation Protocols, Validation Reports, Quality Protocols, Test Methods, and Specifications; Clear (legible), accurate, and complete documentation of test activities on approved worksheets and laboratory notebooks; Manage and track assigned projects; Perform Extractable/leachable studies for container closure systems of drug products; Maintain compliance with required training; Perform pre-formulation laboratory experiments and studies.

PhD or foreign degree equivalent in Chemistry or related field and 3 years of experience in job offered or as a Chemist, Analytical Chemist or Analytical Scientist. Employer also accepts Master’s or foreign degree equivalent in Chemistry and 6 years of experience in the job offered or as a Chemist, Analytical Chemist or Analytical Scientist or Bachelor’s or foreign degree equivalent in Chemistry or related field and 8 years of experience in job offered or as a Chemist, Analytical Chemist or Analytical Scientist. Special skills – Experience with laboratory instrumentation such as HPLC, GC, LC-MS, GC-MS, FTIR, and UV-Vis; working with different LC detectors such as RI, ELSD, CAD and MS; HPLC; and GC, particle size, wet chemistry or DSC/TGA. Minimal (0- 5%) domestic travel required.