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Formulation R&D, Research Scientist

Job Description

Edenbridge Pharmaceuticals is seeking a senior formulation scientist to join the company in its product development R&D laboratory in Whippany, NJ. This is a unique opportunity for an individual to join an emerging specialty pharmaceutical company in its generic drug product R&D laboratory. The successful candidate will:

  • Work closely with the company's VP of Product Development and VP of Analytical R&D.
  • Be comfortable working in an independent start-up atmosphere.
  • Take the lead role and a hands-on approach to all aspects of the R&D laboratory's product development function using a QbD approach, including all prototype development, API characterization, excipient selection, and process development. The target delivery systems will initially be oral dosage forms, including tablets, capsules and liquids.
  • Be responsible for all processing equipment in the R&D laboratory.
  • Support the transfer of drug product manufacturing from the R&D laboratory to third party CMOs.
  • Author product development reports and other technical documents related to the formulation development activities.
  • Provide formulation and process support and troubleshooting for both current commercial products and products under development at third party laboratories.
  • Use formulation experience and scientific literature to develop, justify and/or investigate formulation and processing techniques.
  • Qualifications

  • Experience in the formulation of generic oral finished dosage drug products is required.
  • Bachelor's degree with 3-7 years, Master's degree with 2-5 years or PhD degree with at least 1 year of relevant pharmaceutical industry experience.
  • Must be comfortable working within an R&D laboratory setting and knowledgeable about the requirements of operating & maintaining an R&D laboratory.
  • Self-starter who can be effective with minimal supervision.
  • Strong equipment skills necessary to select, purchase, set-up, operate and maintain lab-scale processing equipment.
  • Eligible to work with controlled substances and represent the Company before the US DEA.
  • Excellent communication and interpersonal skills with all levels of the company.
  • Writing skills consistent with the ability to prepare concise, timely and accurate reports.
  • Experience with US FDA regulated pharmaceutical development.

Qualified candidates should submit their resumes directly to careers8@edenbridgepharma.com.