Senior Scientist

Frontage Laboratories • Exton, PA

9d • Onsite

About The Position

Senior 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 Principal Scientist pursuant to approved protocols, Frontage’s SOPs and ICH Guidance; document and report all testing data in lab reports; perform assigned tasks on schedule according to standard operating procedure 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 Biology, Biotechnology, Chemistry, Environment and Sustainability or a related field.
• Experience or coursework in laboratory equipment operation, biological sample processing, data collection and documentation of test results, quantitative analysis of biological data using software such as Excel or R, generating tables, figures, and reports for large datasets, interpreting statistical results. Experience can be gained while pursuing degree.
• Knowledge of analytical techniques such as LC/MS, chromatography analysis, chemical analysis principles and HPLC, Good Laboratory Practice (GLP) and compliance with standard operating procedures.

Responsibilities

• 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 Principal Scientist pursuant to approved protocols, Frontage’s SOPs and ICH Guidance
• document and report all testing data in lab reports
• perform assigned tasks on schedule according to standard operating procedure 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: Mid Level
• Number of Employees: 501-1,000 employees