Scientist

Frontage Laboratories • Exton, PA

4d • Onsite

About The Position

For a CRO (Frontage Laboratories, Inc. – Exton, PA): conduct chemical 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, method validation and sample analysis under the guidance of Senior Scientists pursuant to approved protocols, Frontage’s SOPs and ICH Guidance; document and report all testing data in laboratory reports; perform assigned tasks on schedule according to SOPs and supervisor instructions; attend SOP, safety and scientific trainings to remain current with cGMP regulations and safety standards.

Requirements

• Master of Science or foreign equivalent degree in Chemical Engineering, Chemistry, Pharmaceutical Science or a related field.
• Proficiency in study of cell culture, fixation and molecular beacon staining to develop nucleic acid probes targeting intracellular BAX-expressing mRNA, examining dose-dependent response in TK6 cells following irradiation with X-rays via imaging flow cytometry and RT-qPCR, operating pipettes, cell counters and flow cytometry bioanalytical instruments.

Responsibilities

• Conduct chemical 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, method validation and sample analysis under the guidance of Senior Scientists pursuant to approved protocols, Frontage’s SOPs and ICH Guidance.
• Document and report all testing data in laboratory reports.
• Perform assigned tasks on schedule according to SOPs and supervisor instructions.
• Attend SOP, safety and scientific trainings to remain current with cGMP regulations and safety standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior