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Product Development & Technical Services Manager

Job Description

Edenbridge Pharmaceuticals is seeking a pharmaceutical scientist 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 manage development and manufacturing partners across North America and Western Europe. The successful candidate will:

  • Manage third party development and contract manufacturing operations for the Company.
  • Oversee a broad development portfolio of oral Rx dosage forms, including tablets, capsules and liquids.
  • Provide technical guidance to help troubleshoot and resolve formulation, manufacturing and analytical issues for commercial products.
  • Oversee batch manufacturing at third party CMO sites, including hands-on involvement for registration and validation batches.
  • Review, edit and approve written work product from development and manufacturing partners, including product development reports, stability protocols & reports, manufacturing & packaging batch records, product transfer reports and process validation protocols & reports.
  • Coordinate the activities and communications amongst multiple disciplines and partners for each respective project.
  • Lead weekly meetings with partners to keep projects on schedule and focused on timely completion of established goals.
  • Support NDA and ANDA filings and management of responses received from the FDA.
  • Qualifications

  • Bachelor's degree with 5+ years, Master's degree with 3-5 years or PhD degree with at least 1-3 years of relevant pharmaceutical industry experience.
  • Extensive hands-on experience in drug product formulation and manufacturing required, preferably in generic Rx products.
  • Self-starter who can be effective with minimal supervision.
  • Strong leadership skills necessary to oversee development and manufacturing activities at third party facilities.
  • Excellent communication and interpersonal skills across 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 and manufacturing.

Qualified candidates should submit their resumes directly to careers3@edenbridgepharma.com.