Senior Scientist, Analytical Research & Development in Durham, NC at Integrated Resources, Inc

Date Posted: 6/25/2020

Job Snapshot

  • Employee Type:
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Will support formulation development work by developing (with some guidance and support) and validating suitable analytical test methods, with a focus on GC methods.
Will perform hands-on lab work and may coordinate work with junior level analytical staff. Need to provide routine characterization of the R&D formulations and should provide analytical support for studies necessary for chemistry and manufacturing controls. In addition, should be capable of troubleshooting methods and work with formulation scientists in developing assay methods (active and critical excipients), fast LC methods for DDU and APSD analytical finish, and transferring methods to the quality control (QC) laboratory.
Must be able to draft test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP. Ability to guide junior level analytical scientists and chemists is preferred and should work closely with formulation scientists. Good oral and written communication skill and working in a team environment
Troubleshoot equipment problem and work with instrument manufacturer to resolve issues. Coordinate equipment qualification and calibration. Organize and maintain laboratory for efficient operation.

BS with 5+ years of experience (pharmaceuticals or related) or MS in Science with 3+ years of experience (pharmaceuticals or related)
Experience in test method validation
Experience with HPLC and GC, including strong GC MD skills
Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing up to 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting).

Experience with test method development
Experience with MDI product testing
Experience developing generic products, including inhalation products
Familiarity with cGMP regulations, FDA guidance documents and QbD
Able to wear a respirator.