Pharmaceutical science professional versed in analytical chemistry and highly effective at following USP methods, internal SOPs and GMP practices.
Extensive knowledge of analytical testing of oral and topical dosage forms
Experience with training chemists on analytical test methods and techniques
Performing analysis of drug substances and drug products using United States Pharmacopoeia (USP) methods and internal SOPs
Documentation of test procedures into laboratory notebook per cGMP requirements
Elizabeth City State UniversityBachelor of Science: Pharmaceutical SciencePharmaceutical Science
Mayne PharmaGreenville, NCAnalytical Chemist
Follows all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function.
Under general supervision, performs routine and non-routine testing for chromatographic and spectrophotometric methods of analysis in support of pharmaceutical API and product development.
Testing can include but is not limited to assays (potencies, related substances, residual solvents, metals, etc.), rate of release (dissolution), moisture, identification, and other various wet chemistry based measurements.
HPLC based methods are commonly employed along with titrations, UV and IR.
Assists senior laboratory personnel in method development and validation of analytical techniques.
Effective at using Empower to support testing of routine and non-routine analyses.
Solves problems with a single method, instrument or process and under guidance of senior lab personnel; interprets data, draws conclusions, and makes recommendations to supervision/team leader.
Performs other duties related to the position when required by laboratory management.
American Association of Pharmaceutical Scientists, Member
American Chemical Society, Member
Theoretical knowledge of analytical techniques
Motivation and ability to solve complex problems
Experience in use of a range of software, techniques and instruments to carry out research and analyses