Bachelor's degree in Biochemistry, Chemistry, or Biology; advanced degree preferred.
5+ years of relevant scientific experience; CRO/industry experience is a plus.
Proficiency in immunoassay development; ability to manage multiple projects simultaneously.
Hands-on experience in pharmacokinetics (PK) or pharmacodynamics (PD)/biomarkers, ADA assay development.
Familiarity with FDA and ICH guidelines for method validation and sample analysis.
Experience in a GLP-compliant setting preferred.
Familiarity with immunoassay techniques (e.g., ELISA, MSD, Gyrolab, AlphaLISA).
Experience with Watson LIMS preferred.
Strong verbal and technical writing skills; capable of presenting research findings.
Responsibilities
Conduct innovative research for ligand binding assay development using cutting-edge technologies.
Perform regulatory-compliant assays including PK, PD/biomarkers, and ADA.
Analyze and interpret data, creating summary tables and troubleshooting assay performance.
Collaborate effectively within and across teams to meet project deadlines.
Support the associate director in achieving business objectives related to method development and market growth.
Develop methods while adhering to scientific theories and regulatory requirements in bioanalytical studies.
Provide technical guidance and leadership to study teams to ensure timely project completion.
Author scientific manuscripts and present findings at conferences.
Offer expertise during client interactions.
Benefits
Opportunity to contribute to life-saving treatments through innovative research.
Supportive work environment that emphasizes teamwork and collaboration.
Engagement in cutting-edge scientific research and technologies.
Possibility for professional development and advancement in career.
Involvement in publishing and presenting research, enhancing professional visibility.
Full Job Description
Celerion is seeking a Scientist to join our Ligand Binding Assay Development team. The successful candidate will have strong problem-solving skills, scientific expertise and knowledge in Ligand Binding bioanalytical method development.
This full-time role is located at our Lincoln, NE facility.
As a Scientist, Method Development, you will provide scientific expertise and method development skills to the Ligand Binding Assay Development group at Celerion. A key component of the role is to provide innovation and change management required to remain on the cutting edge of Ligand Binding Bioanalytical Sciences.
Responsibilities:
Undertake original and innovative research and techniques that include developing ligand binding assays utilizing state-of-the-art technologies for the rapid and accurate analysis of protein/peptides/ antibodies in biological matrices
Perform assays (pharmacokinetics (PK), pharmacodynamics PD)/biomarkers, ADA) according to regulatory and quality systems
Analyze and interpret data, generate summary tables, and troubleshoot assay performance, as well as peer-review raw data for accuracy and completeness
Work effectively within a team and across teams to meet objectives under time constraints
Support the associate director in achieving challenging business objectives for the method development team. Includes innovation, change management, evaluation of new technology, and growth in market share, revenue, profit, and customer loyalty.
Develop methods by applying and interpreting scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies
Provide technical/scientific guidance and leadership to study teams, as well as other areas of the company to ensure project completion in a timely manner
Author scientific manuscripts for publication in peer-reviewed journals and present research findings through posters and oral presentations at scientific conferences
Participate and provide technical expertise during client calls and visits
Requirements:
Minimum of a Bachelor's degree in Biochemistry, Chemistry or Biology required. An advanced degree is preferred.
5+ years of related scientific experience preferred, CRO/industry experience is a plus
The candidate must have proven proficiency in immunoassay development and be capable of working on multiple projects simultaneously
Strong hands-on experience in at least one of the following pharmacokinetics (PK), pharmacodynamics (PD)/biomarkers, ADA assay development
Understanding of FDA and ICH guidelines in method validation and sample analysis
Prior experience working in a regulated GLP-compliant environment is preferred
Experience in one or more immunoassay techniques (Ligand Binding assay: ELISA, MSD, Gyrolab, AlphaLISA)
Experience using Watson LIMS is preferred
Excellent verbal and technical writing skills and be capable of presenting to an audience of researchers from a variety of disciplines
Ability to work well with a team and with staff in other locations effectively
