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Quality Control Analytical Specialist

Elanco

Last Updated: 12/02/22

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.

Looking for a role with purpose? Want to impact Elanco’s Healthy Purpose to advance the well-being of animals, people, and the planet, enabling us to realize our vision of Food and Companionship Enriching Life? Are you an experienced scientist familiar with biotechnology in-process and release testing? Enjoy modernizing, optimizing, and troubleshooting existing and new analytical methods in a Quality Control (QC) Laboratory?

This role will work cross-functionally with QC, Technical Services, Regulatory Affairs, other Quality Control advisors, and external specialists to identify, remediate and implement assays used for characterization of biotechnology products, specifically avian viral and bacterial vaccines. The candidate will utilize their experience with technical writing, experimental design, mentoring and training technicians and leading through influence to support transformation of the QC laboratory in Winslow, ME.

Responsibilities

  • Designs, conducts and oversees the execution of laboratory experiments including analytical method development, validation and transfer. Primary techniques are viral titration (cell and egg based), ELISA, SDS-Page, bioassays, serological assay, immunofluorescence and proof of inactivation.
  • Assists with the designing and conducting personnel training, laboratory investigations, troubleshooting and project management.
  • Interfaces with other scientists in a variety of technical disciplines including process development, formulation development, clinical operations, quality control, quality assurance, discovery, and manufacturing.
  • Provides innovative solutions to historical assay issues utilizing individual and network technical knowledge.
  • Proposes, evaluates, and independently applies basic scientific principles and keeps abreast of new methods and advances in product characterization.
  • Participate in process and analytical technology transfer, statistical process control development, process technical evaluations, process quality improvements (PAT), and site technology infrastructure strategy and implementation.
  • Provide technical guidance to the laboratory, site and Elanco biotechnology network on various analytical topics, including method development and improvements, approaches to troubleshooting significant analytical technical issues, references, and regulatory initiatives.
  • Participate in developing analytical and vaccine manufacturing control strategies and technical problem solving.
  • Prepares verification and validation studies in accordance with current regulatory guidance
  • Assists with projects involving target animal safety exemptions

Minimum Requirements

  • B.S. in immunology, microbiology virology, biochemistry, analytical chemistry, veterinary sciences or animal science, with a minimum of 4 years of experience, M.S. with a minimum of 2 years of experience.
  • Relevant industry and/or laboratory experience.
  • Must possess skills and knowledge within a field such as cellular, immunological, molecular, bioanalytical and chemical test methods. (Experience with avian virology and bacteriology preferred)
  • Must have a thorough understanding of USDA and EMEA regulatory requirements
  • Skills and past experience in experimental design, technical problem solving and continuous improvement

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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



Company Details

Greenfield, Indiana, United States
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health...