Senior Bioanalytical Scientist

Elanco • Fort Dodge, IA

2d

About The Position

Elanco is seeking a Senior Bioanalytical Scientist to support its QC Department and assigned Analytical Sciences and Technology (AS&T) projects. The role establishes and monitors assay capability and control programs, analyzes assay variability and reference stability, and uses results to direct improvement efforts. It also leads a formal data-analysis program for tracking prototyping and blend calculations and serves as the site expert for implementation, routine use, syntax updates, and quality assurance related to SoftMax software.

The position conducts and supports testing for development, validation, transfer, remediation, troubleshooting, and optimization of QC analytical assays. Techniques include ELISA, western blotting, SDS-Page, capillary electrophoresis (CE), bioassays, viral titrations, serological assays, immunofluorescence, and proof of inactivation. The scientist helps ensure tests and procedures are scientifically robust, accurate, and compliant with applicable corporate standards, 9CFR, OSHA, EPA, USDA, cGMPs, and customer requirements.

The role also coordinates program milestones and departmental projects, communicates with stakeholders, manages laboratory supplies and equipment, trains others, and helps develop and revise procedures and policies. Less than 10% domestic travel is required for business meetings and conferences.

Requirements

• Master’s degree in Biotechnology, Bioengineering, Genetics and Genomics, a related field, or a foreign equivalent.
• At least 2 years of post-baccalaureate experience in the job offered or in engineering/bioanalytics-related roles.
• At least 2 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.
• At least 2 years of experience with SoftMax, including creating or updating syntax used for calculations.
• At least 2 years of experience implementing SoftMax syntax updates in a regulated laboratory as part of quality assurance.
• At least 2 years of experience validating biological assays.
• At least 2 years of experience transferring biological assays.
• At least 2 years of experience as a QC analytical scientist in the animal vaccine industry, including regulatory documents and aspects such as CFR, VSM, and OoP.
• At least 2 years of experience developing biological assays.

Responsibilities

• Establish an Assay Capability & Control Program to quantify assay variability and direct resources toward assay improvement.
• Launch and track a program for Elanco’s prototyping and blend calculations using data analysis.
• 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, including statistical analysis of assay performance and variability.
• 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.
• Manage reagent and supply inventories; operate and maintain calibrated standard equipment; and keep the laboratory clean and orderly.
• Communicate schedules, test statuses, and concerns effectively.
• Train others on methods and procedures, and initiate the creation, development, and revision of procedures and policies.
• Validate new equipment, systems, and processes; coordinate group or departmental projects using strategic planning; and uphold high ethical and professional standards.
• Support QC laboratory experiments involving analytical method development, validation, transfer, remediation, and optimization.
• Ensure the scientific robustness, accuracy, and compliance of tests and procedures with applicable corporate standards, 9CFR, OSHA, EPA, USDA, cGMPs, and customer requirements.
• Attend business meetings and conferences requiring less than 10% domestic travel.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior