Scientist, Method Development - Ligand Binding Assays

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you! 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