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Scientist-Analytical III

  • Unicon Pharma
  • 01/04/20
  • Lake Forest, IL
  • 60045
  • 33.00 / Hourly
  • Contractor
Job Description:
Leads and plans analytical laboratory assignments and activities to meet established project goals and timelines. Provides extractable and leachables and impurity identification support in developing new products.
Assists in LC/MS or GC/MS method development and executes method validations and method transfers.
Designs and executes extractable and leachables studies per USP and .
Prepares and reviews technical documents, including protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required.
Ensures that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.
Assists in performing laboratory investigations.
Work directly with parties beyond R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMOs), and involvement with other divisions of client.
Evaluates new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes.
Performs duties with a high level of independence.

Bachelors degree in the physical or biological sciences with 8 to 10 years of industry experience, MS with 4 to 5 years of industry experience or PhD degree with 1 to 2 years of industry experience.
Must have strong experience in extractables/leachables, chromatography and mass spectrometry (LC/MS, GC/MS).
Strong written and oral communication skills and the use of MS Office (Word, Excel) are required
Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

Key Skills:
Assists in LC/MS or GC/MS method development and executes method validations and method transfers. Experience in extractables/leachables,

Employer Information

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