Scientist for Frontage Laboratories, Inc. - Exton, 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, validation and verifications 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 Out of Tolerance (OOT) investigations, specifications, and analytical documents for method validation and ANDA submissions; perform release and stability testing, impurity identification, component screening, qualification and cleaning validation; conduct in vitro permeation test (IVPT) and in vitro release test (IVRT) studies using radiolabeled and non-radiolabeled compounds; conduct bioanalytical assays using HPLC and LC/MS; and generate data for mass balance studies.
1. Master of Science or foreign equivalent degree in Bioengineering, Biotechnology or a related field.
2. 1 year experience in job offered or 1 year research experience. This required experience must include biohazard materials handling, biomaterial synthesis, characterization, cytotoxicity experiment and cell culturing, designing experiment incorporating biological samples, developing 3D collagen hydrogel experiments and image live cells using a fluorescent microscope, synthesis and functionalization of micro and nanoparticles, synthesis and functionalization of peptides and operation of various protein processing technologies including solid liquid separation and protein purification. Experience can be gained while pursuing degree.
3. Proficiency in HPLC/UPLC, Mass spectrometry (MS), UV-Vis Spectroscopy and Microscopy, Chemdraw, JMP, SPSS, Image J, Chimera and Unscrambler X.