For Frontage Laboratories, Inc. – Exton, PA, plan and execute product development experiments for complex drug product projects from pre-formulation design through clinical manufacture based on QbD and DoE principles; perform pre-formulation and formulation development studies of oral solid dosage forms, excipient screening, compatibility study, tablet compression and test, tablet coating, stability study design; perform development and filing of ANDA’s and 505(b) 2 regulatory filings; draft experimental batch records and Quality by Design (QbD)-based report; develop prototype formula proficiency in HPLC, dissolution apparatus, UV-Vis Spectra, fluid bed coating machine, tablet compression machine, high shear granulator, hardness & density tester, disintegration tester, particle size analyzer; utilize experimental design to rapidly optimize formulation composition and in-process specifications; troubleshoot formulation issues that occur during research and development, scale-ups and /or in production; draft regulatory submission document; design and perform excipient screening and formulation feasibility studies for various Active Pharmaceutical Ingredient (API); perform technology transfer when production is performed in different manufacture sites to ensure the results consistency; conduct laboratory investigations and prepare investigation reports.
- Master or foreign equivalent degree in Chemistry, Pharmaceutical Science, Chemical Engineering, or a related field.
- 2 years experience in job offered or 2 years experience as a Scientist in the pharmaceutical industry. The required experience must include solid product development, formulation, and processing development of generic drugs containing water-insoluble API, design oral dosage formulations meeting FDA guidance, pharmaceutical manufacturing per cGMP procedures, optimization of manufacturing processes, use of bi-layer tablets press, fluid bed (top and bottom spray), roller compactor, co-mill, encapsulator and tablet coater, high shear granulator, tablet laser drilling machine, tablet printing machine, development of tablet and capsule formulations for controlled release and delayed release and manufacture GMP batches.
- Proficiency in HPLC, GC, UV, FTIR, wet chemistry techniques, chromatography, spectroscopy, and spectrophotometry techniques.