Job Information
Frontage Laboratories, Inc. Scientist (Group Leader) in Exton, Pennsylvania
For a CRO (Frontage Laboratories, Inc. - Exton, PA): plan, execute, and supervise product development experiments for complex drug product projects from pre-formulation design through Clinical Trial Material (CTM) manufacturing; write, review, and approve Pharmaceutical Development Report (PDR) for CTM Batch Manufacturing; design phase-appropriate formulations for drug development ranging from preclinical to clinical phase II, and for CTM manufacturing of sterile and non-sterile pharmaceutical dosage forms; oversee and modify formulations containing High-Potency Active Pharmaceutical Ingredients (HPAPIs); develop analytical methods, prototype formulations and predetermined Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) for drug products and substances; and comply with all regulatory requirements.
Requirements:
Master of Science or foreign equivalent degree in Pharmaceutical Sciences, Chemistry, or a related field.
2 years of experience in the job offered or 2 years of experience as a Scientist in Formulation and Development in the pharmaceutical industry. The required experience must include experience in pre-formulation studies, excipient compatibility studies, component compatibility studies, and prototype formulation and processing development of generic drugs containing HPAPIs and design oral dosage formulations meeting FDA guidance, pharmaceutical manufacturing per cGMP procedures and optimization of manufacturing processes.
Please submit your resume to the company at the following address:
Xiayue (Summer) Yin, Esq., Associate Legal Counsel, Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341.