What are the responsibilities and job description for the Scientist position at Adare Pharmaceuticals?
For a CDMO (Frontida BioPharm, Inc. - Philadelphia, PA): provide high-quality analytical testing of finished products, raw materials, Active Pharmaceutical Ingredient (API), in-process products and stability samples; provide analytical method development, verifications and validation in Good Manufacturing Practice (GMP) environment; perform analysis of innovator samples and R&D formulations; compile and interpret analytical and statistical data; review and approve protocols, laboratory notebooks, reports, deviations, Out of Specification (OOS) and laboratory event investigations; provide analytical documents for method validation and ANDA submissions; perform release and stability testing, impurity identification, component screening, qualification and cleaning validation; support regulatory and client audit; conduct formulation development/API/Drug Product process and development through hands-on generation of accurate and precise analytical chemistry data using routine laboratory techniques such as liquid chromatography (HPLC,UPLC), USP/EP dissolution testing, gas chromatography (GC), mass spec and Karl Fisher titration.
Requirements:
- Ph.D. or foreign equivalent degree in Chemistry or a related field.
- 1 year experience in job offered or 1 year of research experience.
- The required experience must include protein function and active site plasticity using unnatural amino acid, small molecule synthesis and characterization.
- Experience in CGMP environment, including development and validation of LC-MS/MS compatible analytical method for raw materials, in-process finished drug product and stability sample Proficiency with HPLC/UPLC, LC-MS/MS, ICP-MS, Dissolution apparatus, Particle size analyzer, Empower, Analyst, MassHunter, UV-vis spectroscopies, IR spectroscopies, fluorescence spectroscopies, NMR, PCRs, DNA, protein electrophoresis and protein purification (affinity, SEC, IEX) cell-based assay.