Scientist

frontage laboratories   Exton, PA   Full-time     Science
Posted on October 2, 2021
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Scientist

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. 

Requirements:

  1. Master or foreign equivalent degree in Chemistry, Pharmaceutical Science, Chemical Engineering, or a related field.
  2. 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.
  3. Proficiency in HPLC, GC, UV, FTIR, wet chemistry techniques, chromatography, spectroscopy, and spectrophotometry techniques.