Sr. Associate Scientist, Analytical Research

HIKMAColumbus, OH
Onsite

About The Position

We are seeking a talented and motivated Sr. Associate Scientist, Analytical Research to join our team. In this role, you will be responsible for conducting chemical and physical analyses in support of the development of a manufacturable multisource pharmaceutical product. Providing analytical support for the release of registration materials in support of regulatory submissions. Assisting analytical method validation and transfer activities. You will work closely with Senior and Principal Scientists in the Analytical Research team and Formulation Development team.

Requirements

  • Bachelor’s degree in scientific discipline such as chemistry, pharmacology.

Nice To Haves

  • 6 months+ relevant work experience in pharmaceutical industry including but not limited to the following:
  • For API: UV/Vis, IR, pH meter, wet chemistry techniques, GC and HPLC.
  • For Product: UV/VIS, dissolution, pH meter, wet chemistry techniques, and HPLC
  • Experience with the following analytical techniques:
  • Experience in c-GXP analytical laboratories.
  • Inhalation Testing experience.

Responsibilities

  • Performs the assigned analytical tasks in support of product development, registration lot release, pre and post regulatory submission activities.
  • Performs activities within the assigned timelines and in compliance with cGXP's, and company practices and procedures.
  • Follows work instructions, SOPs and company practices.
  • Documents analytical activities and results accurately, in a timely manner and right-first time and maintains integrity of data.
  • Performs assigned tasks in support process changes (e.g. processes, procedures, etc...) within the assigned timelines.
  • Communicates effectively with peers and supervisor about the status of the assigned tasks, maintaining supervisor constantly updated.
  • Follows written analytical procedures.
  • Identifies execution challenges of analytical methods and support trouble shooting activities.
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