Analytical Chemist
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Job Classification: Technical/Regulatory

Position Summary:Responsible for the execution of sample testing. Able to work independently following the USP, SOP or other written procedures and supervise task-related lab assistant activities.

Job Classification: Technical.

Job Chain of Supervision: Reports to Director, Analytical Services or designee.

Duties:

  • Perform appropriate documentation practices
  • Perform the preparation and testing of samples using HPLC, Dissolution (Apparatus 1 and 2, Rotating Bottle), and Disintegration, GC, CE, UV-vis and other techniques in the USP.
  • Conduct method validations using a pre-approved protocol.
  • Perform data calculations. Review and interpret data and look for trends, anomalies, outliers.
  • Perform peer review of data generated by other analysts and technicians.
  • Perform data investigations with supervision.
  • Write draft reports for product release and stability study samples, as well as method developments and validations.
  • May perform instrument DQ/IQ/OQ/PQ, repair, maintenance and calibration.
  • Train employees on instrument use and scientific techniques.
  • Assure that work is conducted in accordance with GMP requirements, and PharmAssist SOP requirements.

Education/Experience Requirements:

  • M.S., B.S./B.A., or A.S./A.A. in Chemistry or other laboratory-based science with related laboratory experience.
  • Demonstrated ability to perform basic analytical skills, such as balance use, pipetting, bringing to volume, mixing, preparing reagents, etc.
  • Familiarity with Excel, Word Perfect, Word computer software.
  • Theoretical understanding of chemistry and demonstrated ability to perform related mathematical and statistical calculations.
  • Demonstrated ability in the use of HPLC, Dissolution (Apparatus 1 and 2, Rotating Bottle), Disintegration, GC, CE, UV-Vis and/or other instrumental techniques.

Orientation Training Requirements:

  • Training in CFR 21 (cGMP regulations).
  • Training in applicable ICH, USP, FDA testing guidelines.
  • Training in applicable PharmAssist SOPs.
  • Training in the use of laboratory instrumentation and software.
  • General laboratory safety and waste management.

Annual Training Requirements:

  • Training in CFR 21 (cGMP regulations).
  • Training in applicable PharmAssist SOPs.
  • General laboratory safety and waste management.
  • Technical advancement through outside courses, internal research, and/or publications.

Please submit a cover letter and your resume by email to: 

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