Senior Bioanalytical Scientist

Elanco•Fort Dodge, IA

18h

About The Position

At Elanco, the Senior Bioanalytical Scientist supports the QC Department and assigned AS&T projects through analytical method development, validation, transfer, remediation, troubleshooting, and optimization of QC analytical assays. The role establishes an Assay Capability & Control Program to quantify assay variability and uses findings to guide improvement efforts, launches a data-analysis program to track prototyping and blend calculations, leads the reference stability monitoring program, and serves as the site expert for implementation, routine use, syntax updates, and quality assurance related to SoftMax software. The position conducts statistical analysis of assay performance, plans and monitors program milestones, and communicates with departments and stakeholders about schedules, testing status, and concerns. It also manages reagent and supply inventories, operates and maintains calibrated standard equipment, and ensures an orderly laboratory. The scientist trains others, develops and revises procedures and policies, validates new equipment, systems, and processes, and coordinates projects while maintaining high ethical and professional standards. Primary techniques include ELISA, western blotting, SDS-Page, CE, bioassays, viral titrations, serological assays, immunofluorescence, and proof of inactivation. The role assures scientific robustness, accuracy, and compliance with corporate standards, 9CFR, OSHA, EPA, USDA, cGMPs, and customer requirements, as applicable. Less than 10% domestic travel is required to attend business meetings and conferences.

Requirements

Master’s degree in Biotechnology, Bioengineering, Genetics and Genomics, a related field, or a foreign equivalent.
Two years of post-baccalaureate experience in the job offered or in engineering/bioanalytics-related roles.
Two years of experience with a reference stability monitoring program, including data compilation per the CVB Data Guide, quality and statistical work, and final report submission to CVB.
Two years of experience with SoftMax, including creating or updating syntax used for calculations.
Two years of experience implementing SoftMax syntax updates in a regulated laboratory as a quality assurance responsibility.
Two years of experience validating biological assays.
Two years of experience transferring biological assays.
Two years of experience as a QC analytical scientist within the animal vaccine industry, including regulatory documents and aspects such as CFR, VSM, and OoP.
Two years of experience developing biological assays.

Responsibilities

Establish an Assay Capability & Control Program to quantify assay variability and use results to direct assay-improvement efforts and resources.
Launch a data-analysis program to track Elanco's prototyping and blend calculations.
Plan, execute, and monitor program launch milestones to support timely completion and stakeholder satisfaction.
Serve as the site expert for SoftMax implementation, routine use, syntax updates, and related quality assurance.
Lead the reference stability monitoring (RSM) program.
Conduct statistical analysis of assay performance to evaluate variability and improvement targets.
Conduct testing for method development, validation, transfer, remediation, troubleshooting, and optimization of QC analytical assays for assigned AS&T projects.
Prioritize work and implement quality and efficiency improvements.
Maintain communication with other departments and stakeholders, including communicating schedules, test statuses, and concerns.
Manage reagent and supply inventories, operate and maintain calibrated standard equipment, and maintain a clean and orderly laboratory.
Train others on methods and procedures and initiate the creation, development, and revision of procedures and policies.
Validate new equipment, systems, and processes and coordinate projects within the group or department using strategic planning.
Support QC laboratory experiments involving analytical method development, validation, transfer, remediation, and optimization.
Ensure tests and procedures are scientifically robust, accurate, and compliant with applicable corporate and regulatory standards.