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Research Scientist I, AR & D

Company: Amneal Pharmaceuticals
Location: Piscataway
Posted on: November 19, 2021

Job Description:

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 testingAdditional 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.Qualifications - ExternalEducation:
                      • 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 - PreferredExperience:
                            • 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. - IntermediateSpecialized 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

Keywords: Amneal Pharmaceuticals, Trenton , Research Scientist I, AR & D, Other , Piscataway, New Jersey

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