Senior Director of Analytical Development at Eagle Pharmaceutical in Woodcliff Lake, NJ

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Description

Eagle is a specialty pharmaceutical company working to advance safe and efficient injectable treatments for patients across oncology, critical care, and orphan diseases.  As a group of inventors, visionaries, and life science leaders, we are bound by the belief that patients deserve the best possible experiences in healthcare. That’s why our focus on engineering new formulations is designed to make life-saving medicines easier to use. We discover and develop new formulations to make medicines more convenient and faster to use. We look to unlock the potential in proven medicines to benefit more patients and healthcare providers.   Our goal is to provide safe and accessible products through the application of innovative formulation technology to FDA-approved medicines, as well as through the discovery and development of novel therapeutic agents.



 



Eagle Pharmaceuticals Inc. is seeking a Senior Director of Analytical Development to oversee their efforts at Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO).



 



Job Description



 



  • Using a strong technical background, provide leadership in the development of 505(b)(2) parenteral products.

  • Leading the CRO and CMO in development and validation of analytical methods and launches of new products.

  • Identifying new CROs and CMOs to partner with in development and manufacturing.

  • Review Drug Master Files to assure material complies with guidelines.

  • Prepare documents for Investigational New Drug and New Drug Application submissions.

  • 15% Domestic Travel.

  • Great knowledge of Current Good Manufacturing Processes.

 



Job Requirements



 



  • Experience in Analytical Development

  • 505(b)(2) New Drug Application experience

  • Ph.D. 10+ years, BS with 17+ years, MS with 15+ years of Pharmaceutical experience

  • Some Parenteral product experience

  • Knowledge of Current Good Manufacturing Processes

  • Experience managing an internal and external staff

 



The above requirements and qualifications are meant to describe the general nature of the position and do not represent all duties to be performed by the selected candidate. Please note that only candidates who are under consideration for the position will be contacted. 



 



If interested in this position, please submit your resume at https://careers-eaglepharmaceuticals.icims.com/jobs/1066/senior-director%2c-analytical-development/job

 



All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.



 

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