Senior Bioanalytical Scientist

Elanco in; Fort Dodge (IA); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Elanco, a global leader in animal health, is seeking a QC Analytical Scientist to lead assay capability, data-driven improvements, and regulatory-compliant testing. You will drive method development, validation and transfer while coordinating with cross-functional teams.

Domestic travel up to 10% may be required. You will apply advanced statistics and QC analytics across ELISA, western blotting, SDS-PAGE, CE, and bioassay workflows to ensure robust, compliant results.

Formación

• Master’s degree in Biotechnology, Bioengineering, Genetics and Genomics or related field.
• 2 years post-baccalaureate experience in reference stability monitoring, data analysis, SoftMax, and QC analytical assays.
• Experience with validation, transfer, and development of biological assays.
• Willingness to travel up to 10% domestically.

Responsabilidades

• Establish Assay Capability & Control Program and use results to direct improvement targets.
• Launch a formal program to track prototyping and blend calculations using data analysis.
• Lead the planning, execution, and monitoring of program milestones with stakeholders.
• Serve as site expert for SoftMax implementation, syntax updating, and QA aspects.
• Lead the reference stability monitoring (RSM) program.
• Statistical analysis of assay performance to evaluate variability and targets.
• Conduct testing for method development, validation, transfer, remediation, and troubleshooting QC assays.
• Maintain strong communication with other departments and stakeholders.
• Manage inventories of reagents, calibrate equipment, and maintain a clean lab environment.
• Train others on methods and initiate creation/update of procedures and policies.
• Validate new equipment, systems, and processes; coordinate projects and uphold high ethical standards.

Conocimientos

Data analysis

Quality assurance

Laboratory techniques

Educación

Master’s degree in Biotechnology, Bioengineering, Genetics and Genomics

Herramientas

SoftMax

Descripción del empleo

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your day-to-day will include:

• 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.

You have the following technical skills and qualifications:

• 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.

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 Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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 of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.