Senior Bioanalytical Scientist

• Establish Assay Capability & Control Program (quantify assay variability) and use the results to direct efforts/resources towards additional assay improvement targets.
• Launch a formal program to track Elanco’s prototyping and blend calculations using data analysis.
• Lead the planning, execution, and monitoring of program launch milestones, ensuring timely completion and stakeholder satisfaction.
• Serve as site expert for implementation, routine use, syntax updating, and quality assurance aspects related to SoftMax software.
• Lead the reference stability monitoring (RSM) program. Statistical analysis of assay performance to evaluate assay variability and targets for improvement.
• Conduct testing for method development, validation, transfer, remediation, and/or troubleshooting/optimization of QC analytical assays for assigned AS&T projects, prioritizing work and implementing quality and efficiency improvements.
• Maintain strong communication with other departments and stakeholders.
• Manage inventories of reagents and supplies, operate and maintain calibrated standard equipment, and ensure a clean and orderly laboratory environment.
• Demonstrate strong technical knowledge of basic scientific principles, and effectively communicate schedules, test statuses, and concerns.
• Train others on methods and procedures, and initiate the creation, development, and revision of procedures and policies.
• Validate new equipment, systems, and/or processes, coordinate projects within the group or department using strategic planning and uphold high ethical and professional standards to maintain Elanco's excellent reputation.
• Support the QC Department with the execution of laboratory experiments including analytical method development, validation, transfer, remediation, and optimization. Primary techniques are ELISA, western blotting, SDS-Page, CE, bioassays, viral titrations, serological assay, immunofluorescence, and proof of inactivation.
• Assures the scientific robustness, accuracy, and compliance of all tests and procedures to corporate standards, 9CFR, OSHA, EPA, USDA, cGMPs, and customer requirements as applicable.

• Requirement – Master’s degree in Biotechnology, Bioengineering, Genetics and Genomics, a related field, or a foreign equivalent plus 2 years post-baccalaureate experience in job offered or any engineering/bioanalytics related roles.
• Relevant experience – Applicants must have 2 years of experience in the following: (1) reference stability monitoring program, to include data compilation per CVB Data Guide, quality and statistical work, and final report submission to CVB; (2) SoftMax, including experience creating/updating syntax used for the calculations; (3) (Quality assurance) implementation of SoftMax syntax updates in a regulated laboratory; (4) Validation of biological assays; (5) Transfer of biological assays; (6) QC analytical scientist within the animal vaccine industry including regulatory documents/aspects CFR, VSM, and OoP; and (7) Development of biological assays.
• Less than 10% domestic travel required to attend business meetings and conferences.

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