This job listing has expired and the position may no longer be open for hire.

Consultant-Ref Std Coordinator at Elanco in greenfield, Indiana

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

This role will be responsible for the strategic and technical oversight of all corporate reference standard materials used at Elanco.  Perform or coordinate the processes necessary to ensure consistent supply of accurately defined reference standard materials and supporting data to laboratories across the Global QC network.  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.

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

  • 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 specific 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

  • Leads the team consisting of laboratories and other key stakeholders associated with executing the reference standard characterization or re-evaluation.

  • Perform any other duties or serve in such other capacity as may be determined by Company management.

Basic Qualifications:

Education:

  • Bachelors degree in Chemistry, Biology, Engineering, or other applicable scientific discipline.

Experience:


  • Strong working knowledge of analytical laboratory operations with a focus on analytical chemistry..

  • 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.

  • 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, prioritise 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





More jobs in greenfield, Indiana

Management
about 9 hours ago

Elanco
$192,500.00 per year
Management
about 9 hours ago

Elanco
Science
about 9 hours ago

Elanco
$225,000.00 per year
More jobs in General Business

General Business
10 minutes ago

Cross Technologies
General Business
39 minutes ago

Kendo Brands
General Business
39 minutes ago

Kendo Brands