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Responsible for the strategic and technical oversight of corporate reference standard materials used at Elanco.  The Reference Standard Coordinator ensures a consistent high quality supply of reference standards by working with internal and external partners to source and characterize various chemical and biological entities for application as reference materials.  This material is then supplied to the Elanco QC and R&D laboratory networks.  This role will partner closely with R&D to establish new reference standards to support new product development.


In addition, this role will be responsible for driving continuous improvement and operational efficiency through the identification and implementation of new technologies and enhanced capabilities. Activities include specification and acquisition of source material, inventory management, order fulfillment, design of analytical testing protocols, oversight of third party testing laboratories, evaluation of characterization data, documentation of technical rationale for decisions, and publication of profile and Certificate of Analysis documentation for reference standards.  Will collaborate closely with internal and external testing laboratories, as well as the third party facility managing the storage, dispensing, and shipment of reference standard materials.


Job Responsibilities:

  • Designs, authors, and reviews scientific conclusions and content of documents such as reference standard protocols and profiles
  • Directs the acquisition of information and data related to reference standard source batch materials
  • Looks for opportunities to implement creative and novel solutions.
  • Creates and implements new technologies and capabilities when appropriate.
  • Drives continuous improvement and operational efficiency.
  • Understands the analytical procedures utilized for chemical and biological characterization of pharmaceutical materials and how these tests relate to the molecule analytical control strategies.
  • Assesses and acts on analytical data that are generated to support the characterization and suitability of use of reference standards, including statistical analysis and evaluation.
  • Oversees analytical characterization testing performed at third party laboratories.  Identifies appropriate laboratories to perform testing as needed.
  • Understands the proper selection and application of reference standard specifications; participates in the formulation of reference standard specifications
  • Appropriately monitors and manages inventory of reference materials, and performs activities needed to ensure timely resupply of source batch materials
  • Drives decisions regarding establishment and maintenance of reference standards
  • Gains laboratory and molecule technical expert support in resolving difficult laboratory and reference standard issues
  • Drives resolution to obstacles associated with resources, test assignments, and timing associated with laboratory testing
  • Employs detailed analytical problem solving skills to resolve technical issues with broad impact to the organization.
  • Leads investigations of departures from quality standards
  • Anticipates potential gaps in the existing quality system and acts to present resolutions in a timely and proactive manner
  • Perform any other duties or serve in such other capacity as may be determined by Company management.


Minimum Qualifications:

  • Bachelors degree in Chemistry, Biology, Engineering, or other applicable scientific discipline.
  • Strong working knowledge of analytical laboratory operations with a focus on analytical chemistry.
  • Minimum of 5+ years of experience actively working in a pharmaceutical laboratory.
  • Demonstrated experience with analytical characterization of both small and large molecules/biologics.
  • Strong working knowledge in GMP compliance with global regulatory requirements (FDA, MHRA, EMEA, etc.)
  • Previous experience with reference standard characterization and management of reference standard materials.
  • Demonstrated ability to drive continuous improvement and implement novel solutions.
  • Ability to effectively communicate verbally and in writing
  • Ability to effectively influence remote teams and stakeholders
  • Strong problem solving skills and decision-making abilities
  • Ability to influence without authority and negotiate positive outcomes
  • Demonstrated ability in managing a variety of processes and projects
  • Ability to work independently and employ the initiative to find solutions, prioritize and exercise discretion


Additional Preferences:

  • Previous experience providing technical oversight of third party contract laboratory operations.
  • Experience utilizing Veeva QDocs for document management.
  • Experience utilizing Veeva QMS for documentation of deviations and change controls..


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