Director of Technical Services
Edenbridge Pharmaceuticals is seeking a pharmaceutical scientist to join the Company at its Parsippany, NJ corporate 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, work directly with the Chief Scientific Officer 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.
- Master's degree with 7-10 years or PhD degree with at least 5 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 email@example.com.