(Archived) Senior Analyst Bioassay Development

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 position will focus on developing, optimizing and writing reports for analytical methods in support of process development activities and regulatory submissions for biotherapeutic development (e.g. monoclonal antibodies and vaccines). This position will be responsible for designing and implementing biological assays to evaluate biopharmaceutical activity, potency, and stability. The role will require routine interaction with senior scientists across multiple discovery, development, and manufacturing/quality laboratories at Elanco. The incumbent scientist will be expected to support multiple projects at any given time. A strong foundation in protein biochemistry, molecular biology, and cellular biology will be required to proactively search for solutions in this development driven team.

Job Responsibilities:

• Conceptualize, design, optimize, qualify, and transfer assays for biotherapeutics.

• Perform method verification/qualification for biotherapeutic drug substance and drug product on a variety of assay platforms (i.e. cell-based bio assays, ligand binding assays such as ELISA, Octet, MSD, qPCR)

• Transfer knowledge and information from development to manufacturing.

• Document experimental results in notebooks and reports

• Author development, transfer, and regulatory submission documents

Minimum Qualification (education, experience and/or training, required certifications):

• MS or BS in Molecular Biology, Biochemistry, or a related field

• Strong analytical and problem-solving skills; scientific curiosity and creativity

• Demonstrated ability to learn quickly, assimilate new techniques, analyze large datasets

• Effective oral and written communications skills

• High personal ethical and quality standards

• Ability to work productively in an interdisciplinary team environment

Additional Preferences:

• Knowledge/understanding of bioprocessing development

• Experience with ligand binding assays and the generation/validation of cell-based reporter assays

• Knowledge/understanding of USP and/or Ph. Eur. Biopharma methods

• Proven project leadership skills

• Experience with ligand binding assays and the generation/validation of cell-based reporter assays

• Experience interacting with FDA/EMEA/USDA/EPA regulatory reviewers

• Proven project leadership skills

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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