Associate Scientist, Analytical Development at EAGLE PHARMACEUTICAL, INC. in Cambridge, MA

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Description

The Associate Scientist, Analytical Development responsibilities include providing sample-analysis support for formulation development, product development, API testing, and impurities characterizations. This position will also support development and validation of new analytical methods as well as evaluation, optimization, and validation of existing analytical methods to ensure method suitability. In addition, this position will provide support to manage and organize the analytical/formulation laboratory.

 

Responsibilities:

  • Prepares diluents, mobile phases, standard and sample solutions, and operates Agilent 1260 HPLC under the guidance of Sr. Scientist.
  • Performs lab functions including but not limited to providing support to analytical method development, validation, and optimization for formulation/product development.
  • Provides support and conducts testing using various techniques to collect analytical data.
  • Performs sample testing of R&D prototype formulations and compatibility samples.
  • Maintains laboratory notebooks for documenting experimental procedures and results.
  • Follows protocols and analytical test methods to conduct experiments for analytical testing of samples to support product development activities.
  • Provides support to establish and maintain the lab including general lab supplies, equipment and instrument.
  • Interacts with internal team members to provide analytical supports.
  • Complies with all applicable cGMP, GLP and other (e.g., environmental, safety) regulations.

 

Education and Experience:

  • Must have a BS degree in a discipline that draws extensively on analytical, organic, physical chemistry or pharmaceutics, with at least 1 year of experience in wet chemistry laboratory.
  • Experience with general analytical techniques, instrumentation and lab support required.
  • Trained to and experience in handling potent compounds (SafeBridge category 3 and above) 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 send their resume to resumes@tpgstaffus.com and include Associate Scientist, Analytical Development in the subject line.

 

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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