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

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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