(Archived) Bioanalytical Scientist – Quality Control

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.

Are you looking for a company with a clear mission to advance the well-being of animals, people, and the planet? Join Elanco to help us realize our vision of Food and Companionship Enriching Life in our Winslow, ME manufacturing facility. As an experienced scientist with a background in biotechnology in-process and release testing, you’ll drive the modern transformation of analytical methods in our Quality Control (QC) Laboratory.

This Scientist role is ideal for the individual looking to make a meaningful impact while pursuing both their short- and long-term career goals. As a global leader in the animal health industry, Elanco offers a variety of career opportunities inside and outside of the Manufacturing & Quality function at exciting locations around the world.

Reporting to the Senior Quality Director, the incumbent will serve as a primary contact for the implementation of new or improved analytical equipment and techniques, including developing best practices, writing training and use documents and developing implementation/validation protocols. This role will work with a global, cross-functional team, both internal and external to the site, including colleagues from QC, Technical Services and Regulatory Affairs.

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 design and execution of 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.
• Participates with 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.

Basic Requirements:

• B.S. in immunology, microbiology, virology, biochemistry, analytical chemistry, veterinary sciences or animal sciences; Master’s degree preferred
• 5+ years of experience in QC Laboratory
• Thorough understanding of USDA and EMEA regulatory requirements
• Experience in experimental design and technical problem-solving
• Skills and knowledge within a field such as cellular, immunological, molecular, bioanalytical and chemical test methods.
• Experience with avian virology and bacteriology preferred
• Continuous improvement mindset

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