Overview

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This role will be a member of the Elanco Reference Standards Group (ERSG) responsible for the ongoing analytical characterization of the Elanco reference standard portfolio. This is a laboratory-based position and will support the analytical work required for testing of reference standard material, as well as some characterization work of R&D molecules, as needed.  The incumbent will collaborate closely with colleagues to plan and execute laboratory-testing experiments across a wide variety of analytical techniques, as required.  This will include some analytical method development, fit for purpose method qualification/validation, execution of compendial test methods, stability studies of solutions, and generation of other analytical data as needed.

Functions, Duties, Tasks:

  • Perform material characterization utilizing a variety of analytical techniques (NMR, IR, HPLC/UPLC, Karl Fischer titration, XRPD, DSC, DVS,etc.)
  • Employ good documentation practices to thoroughly and accurately document all work in a timely manner, utilizing both electronic and paper documentation systems.
  • Evaluate, interpret and verify analytical data, including second person verification of other analysts’ work.
  • Prepare necessary reagents and solutions, maintain necessary consumables and laboratory supplies, including placing purchase requisitions.
  • Maintain laboratory equipment in a constant state of readiness, according to ISO and cGMP requirements, as necessary. Ensure preventative maintenance and calibrations are executed on time and as planned.
  • Author laboratory method procedures, validation protocols and reports, and other GMP documents.
  • Utilize problem-solving/troubleshooting skills to investigate laboratory issues and identify root cause.
  • Execute and document laboratory investigations appropriately when necessary.
  • Provide technical training to other analysts and cross train on other techniques as required to meet business needs
  • Maintain compliance with company, site and regulatory policies and procedures
  • Work collaboratively between groups to ensure support is being optimized to meet business requirements
  • Participate in planning and troubleshooting meetings in order to find effective solutions and streamline processes
  • Maintain appropriate scheduling and planning to ensure reference standard work is executed within given timelines
  • Perform other duties as assigned

Minimum Qualification:

Education: Bachelor’s degree in chemistry, Biology, Engineering, or other applicable analytical scientific discipline.

Experience:

  • Previous 2-5 years of experience working in a pharmaceutical laboratory, with a preference toward GMP experience.
  • Strong working knowledge of analytical laboratory operations with a focus on analytical chemistry
  • Demonstrated experience utilizing HPLC/UPLC, KF, NMR, IR, and other common techniques within a pharmaceutical testing laboratory.
  • Previous experience authoring analytical method procedures, protocols, and technical reports.
  • Demonstrated knowledge of analytical method validation and qualification, as per ICH guidelines.
  • Knowledge of good documentation practices, including usage of an eLN system.
  • Strong analytical problem solving ability
  • Ability to work collaboratively as well as independently to achieve goals
  • Self-starter with excellent written and verbal communication

Additional Preferences:

  • Knowledge of reference standard management and characterization
  • Previous experience with material characterization studies
  • Previous experience using an electronic document management system (EDMS), such as Veeva QDocs.
  • Previous experience utilizing an electronic Quality Management System such as Veeva QMS

Other Information:

  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Expected travel is less than 10%

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Tagged as: EARLY CAREER, MID TO SENIOR LEVEL

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