26 days old

Research Scientist I, AR & D

Amneal Pharmceuticals LLC
Piscataway, NJ 08854
  • Job Code
    200OR
Description:

  • Research Scientist, Analytical Method Development fulfills a critical role in supporting the analytical development and validation of testing methods for the Analytical R&D laboratory, to characterize drug substance, raw materials, and drug products. The individual is a part of the Analytical Method Development team which develops, validates, and qualifies testing methods for active pharmaceutical ingredients, excipients and dosage forms, including reverse engineering of reference products.

Essential Functions:

  • Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis.
  • Development and optimization of new and existing analytical methods for qualification, release testing of products
  • Provide timely responses to internal and external inquiries.
  • Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities. Expand analytical capabilities of the Analytical Group.
  • Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, purity of components.
  • Evaluate, recommend and implement new analytical technologies and instrumentation for testing

Additional Responsibilities:

  • Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.
  • Leads team members on assigned projects, as required.
  • Participates and leads scientific discussions on projects with cross-functional team.


Education:



  • Bachelors Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences - Required
  • Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences - Preferred
  • Ph. D. in pharmaceutical sciences or related subject - Preferred

Experience:



  • 8 years or more in pharmaceutical experience (with Bachelor's Degree)
  • 6 years or more in pharmaceutical experience (with Masters Degree)
  • less than one year in pharmaceutical experience (with Ph.D.)

Skills:



  • Enthusiasm and dedication performing as an individual contributor and in a team environment. - Intermediate
  • Written and verbal communication and presentation skills. - Intermediate
  • Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate
  • Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
  • Ability to lead projects, and meet deadlines. - Intermediate
  • Creativity to solve technical and compliance problems. - Intermediate

Specialized Knowledge:



  • Broad knowledge of modern analytical equipment and techniques.
  • Extensive experience in cGMP laboratory testing. Hands-on experience with HPLC, GC, TLC, and MS.
  • Method development and validation experience.
  • Experience writing the standard operating procedures (SOPs) and test methods.
  • Experience with regulatory document compilation.







Posted: 2020-10-05 Expires: 2020-11-03
Sponsored by:
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Sponsored by:
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Research Scientist I, AR & D

Amneal Pharmceuticals LLC
Piscataway, NJ 08854

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