Scientist for Frontage Laboratories, Inc. - Exton, PA.
Conduct analytical testing of finished products, raw materials, Active Pharmaceutical Ingredient (API), in-process products, stability samples to support new product formulation development; provide high-quality analytical method development, validation and verifications pursuant to Good Manufacturing Practice (GMP); analyze innovator samples and R&D formulations; generate technical documents required for method validation and ANDA submissions; and perform samples analysis including release and stability testing, impurity identification, component screening, qualification, and cleaning validation.
- Master of Science or foreign equivalent degree in Chemistry, Pharmaceutical Science or a related field.
- 6 months experience in job offered or 6 months experience as a Formulation Chemist. This required experience must include formulation development of solid oral (tablets and capsules) dosage forms (immediate and controlled release), screening and quantitation method, optimize QbD, operate processing, packaging, and testing equipment for batching making and product testings, develop raw material and finished product specifications, stability testing of new products, and HPLC and dissolution methods development of drug products.
- Proficient with HPLC, dissolution apparatus, UV-Vis Spectra, Empower, Chemstation, Chromeleon, Chemdraw, Fluid bed drier, Hardness & Density tester, Tableting machine and particle size analyzer.