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Scientist/ Sr. Scientist, Analytical R&D
at EAGLE PHARMACEUTICAL, INC.
Woodcliff Lake, NJ

Scientist/ Sr. Scientist, Analytical R&D
at EAGLE PHARMACEUTICAL, INC.
Woodcliff Lake, NJ

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Description

Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company working to advance safe, 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.

 

Job Description:

Summary: The Scientist/ Sr. Scientist, Analytical R&D responsibilities include sample analysis supporting formulation and product development activities, API testing and Impurities characterizations. This position will also develop and validate new analytical methods, and will evaluate, optimize and validate existing analytical methods to ensure method suitability. In addition, this position will manage analytical laboratory and provide guidance to junior level scientists and associates.

 

Responsibilities:

  • Operates Agilent 1260 HPLC system.
  • Performs lab functions including but not limited to providing analytical supports for formulation/product development.
  • Characterizes formulations, in-process samples, API and Impurities using various analytical techniques.
  • Performs stability testing of R&D prototype formulations and compatibility samples.
  • Develops and validate new analytical methods, evaluates and optimizes the existing analytical methods to ensure method suitability.
  • Evaluates analytical method development issues to ensure robust and validatable methods.
  • Maintains laboratory notebooks for documenting experimental procedures and results.
  • Writes protocols and reports analyzing analytical results to support development activities.
  • Manage and provides support to establish and maintain the lab including general lab supplies, equipment and instrument.
  • Interacts with internal teams and outside vendors to provide analytical supports.
  • Complies with all applicable cGMP, GLP and other (e.g., environmental) regulations.

 

Education and Experience:

  • Must have an advanced degree, preferably Ph.D. in a discipline that draws extensively on analytical, organic, physical chemistry or pharmaceutics, with at least 2 years of experience in as an analytical scientist in the pharmaceutical industry.
  • HPLC experience is a must (prefer Agilent 1260).
  • General analytical techniques and instrumentation.
  • Trained to and experience in handling potent compounds (SafeBridge category 3 and above) is preferred.
  • Experience in parenteral product development is preferred but not required.
  • Must have experience in developing, validating and transferring analytical methods to support all phases of clinical development.
  • Experience in writing analytical sections of CMC documents for submission to FDA is preferred.
  • Knowledge of cGMPs, ICH guidelines and other CMC regulations for IND/NDA submissions is preferred.
  • Must be a proven team member, with interpersonal skills that have demonstrated effective, harmonious relations with team members and development functions.

 

Interested candidates should apply by sending their resume to resumes@tpgstaffus.com

 

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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