12 days old

Scientist II, AR & D

Amneal Pharmceutical LLC
Piscataway, NJ 08854
  • Job Code
    190JE
Description:

The Scientist II is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment.

Essential Functions:

  • Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
  • Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation.
  • Provides timely responses to all internal and external inquiries.
  • Ensures deadlines are met for product development schedules, and checks that technical and compliance requirements are met.
  • Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
  • Assists with training other members of the analytical development team.
Additional Responsibilities:

  • Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.


Education:

  • A Bachelors Degree (BA/BS) in Chemistry or related science is required.
  • A Master Degree (MS/MA) in Chemistry or related science is preferred.
Experience:

  • 3 years or more of experience in pharmaceutical (with Bachelor's Degree) is required.
  • 1 year or more of experience in pharmaceutical (with Master's Degree) is preferred.
Skills:

  • Enthusiasm and dedication to learn and adopt new analytical techniques. - 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
  • Meet deadlines under pressure. - Intermediate
  • Able to work in a team environment. - 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.
  • Methods development experience.
  • Experience writing the standard operating procedures (SOPs) and test methods.






Posted: 2019-11-24 Expires: 2019-12-23
Sponsored by:
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Sponsored by:
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Scientist II, AR & D

Amneal Pharmceutical LLC
Piscataway, NJ 08854

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