Scientist

For a CRO (Frontage Laboratories, Inc. - Exton, PA): conduct chemical and physical testing of finished products, raw materials, Active Pharmaceutical Ingredient (API), in-process products, stability samples to support new product formulation development for both Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) projects as per the approved test methods; conduct analytical method development, transfer and validation under the guidance of Senior Scientist pursuant to approved protocols, Frontages SOPs and ICH Guidance; and document and report all testing in the laboratory reports.

Requirements:
1. Master of Science or foreign equivalent degree in Pharmaceutical Science, Pharmaceutics, or a related field.
2. 1 year of experience in the job offered or 1 year of experience as a Clinical Research Coordinator. The required experience must include oncology clinical trial (including Phase I/II/III) management, covering protocol adherence, regulatory submissions and compliance with FDA guidelines. Experience can be gained while pursuing degree.
3. Proficiency in HPLC, UV Spectroscopy and LC-MS, PCR, gene extraction, bacterial transformation, Western blotting and cell culture.
4. Knowledge of current Good Manufacturing Practices (cGMP) and Good Clinical Practices (cGCP).

Hours: 40 per week - Monday through Friday.

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