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Analytical Technical Services, Associate Scientist

Job Description

Edenbridge Pharmaceuticals is seeking an analytical chemist to join the Company at its Parsippany, NJ office to support its third-party development and contract manufacturing activities. This is an opportunity for an individual to join a growing specialty pharmaceutical company and work on development and manufacturing projects across North America and Western Europe. The successful candidate will:

  • Review and edit CMC documents from development and manufacturing partners, including analytical methods, method transfer/verification/validation protocols/reports and related analytical R&D documentation.
  • Write, review and edit analytical documents from the Company's internal R&D lab for inclusion in a Technology Transfer Summary report and coordinate tech transfer activities and communications amongst multiple disciplines and partners for each respective project.
  • Review DMF documentation and compendia (e.g., USP, EP) to support transfer and testing of drug substances at third party developers and manufacturers.
  • Be the primary point of contact for third party development and contract manufacturing partners related to analytical R&D issues.
  • Work closely with a Manager level supervisor to provide technical guidance and resolve analytical issues.
  • Organize and manage analytical documentation from third party development and contract manufacturing partners.
  • Work with a broad development portfolio of Rx dosage forms, including tablets, capsules, liquids, ophthalmics and topicals.
  • Support NDA and ANDA filings and management of responses received from the FDA.
  • Qualifications

  • Bachelor's or Master's degree with at least 2 years of generic pharmaceutical industry analytical chemistry experience.
  • Experience in the analysis of drug products, methods development/transfer/validation, methods modification and stability testing and related documentation practices necessary for the US FDA approval process.
  • Self-starter who can be effective with minimal supervision.
  • Excellent communication and interpersonal skills to interact with third party partners and across all levels of the Company.
  • Writing skills consistent with the ability to prepare concise, timely and accurate reports and documentation.

Qualified candidates should submit their resumes directly to careers7@edenbridgepharma.com.