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Celerion is seeking a Senior Scientist to join our Ligand Binding Assay Development team. The successful candidate will have strong problem-solving skills, scientific expertise, and experience in ligand binding bioanalytical method development, with the ability to independently lead complex scientific projects and serve as a trusted technical resource for sponsors and internal teams.
This full-time role is located at our Lincoln, NE facility.
As a Senior Scientist, Method Development, you will provide scientific expertise, method development leadership, and project ownership to the Ligand Binding Assay Development group at Celerion. A key component of the role is to drive innovation and change management while helping the organization remain at the forefront of Ligand Binding Bioanalytical Sciences. The Senior Scientist will also play an active role in sponsor engagement, scientific strategy, mentoring, and developing junior scientists.
Responsibilities:
- Lead and contribute to original and innovative research and techniques, including the development of ligand binding assays using state-of-the-art technologies for the rapid and accurate analysis of proteins, peptides, and antibodies in biological matrices.
- Lead and/or support projects of diverse scope that require non-routine analysis, scientific judgment, and evaluation of complex data.
- Perform and oversee assays for pharmacokinetics (PK), pharmacodynamics (PD)/biomarkers, and anti-drug antibodies (ADA) in accordance with applicable regulatory requirements and quality systems.
- Provide scientific recommendations and defend technical decisions using appropriate data and regulatory/scientific rationale.
- Serve as a key scientific point of contact for assigned sponsors; respond to sponsor questions and requests in a timely, accurate, and professional manner.
- Communicate assay strategy, experimental rationale, results, challenges, deviations, risks, and recommendations to clients with varying levels of scientific expertise; proactively set expectations and escalate issues when appropriate.
- Analyze and interpret data, generate summary tables and technical reports, troubleshoot assay performance, and peer-review data and documentation for accuracy, completeness, and scientific soundness.
- Work effectively within and across teams to meet project objectives and timelines, including prioritizing resources and coordinating work under time constraints.
- Support the Associate Director in achieving challenging business objectives for the Method Development team, including innovation, change management, evaluation of new technologies, 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, and translate scientific findings into practical recommendations for project teams and sponsors.
- Provide technical/scientific guidance and leadership to study teams and other areas of the company to ensure project completion in a timely manner; proactively identify risks, propose solutions, and drive issue resolution.
- Author scientific manuscripts for publication in peer-reviewed journals and present research findings through posters and oral presentations at scientific conferences, as appropriate.
- Lead or participate in client calls and visits, providing technical expertise, presenting data and recommendations, and addressing scientific questions with confidence and professionalism.
- Train, mentor, coach, and provide constructive feedback to scientists and other team members; help develop technical capabilities and promote a culture of scientific excellence and accountability.
Requirements:
- Minimum of a Bachelor’s degree in Biochemistry, Chemistry or Biology required. An advanced degree is preferred.
- 8+ years of related scientific experience; CRO or pharmaceutical/biotech industry experience is a plus.
- Proven proficiency in immunoassay development, with the ability to independently manage multiple projects and priorities simultaneously.
- Demonstrated scientific leadership, project ownership, and accountability for successful delivery of complex bioanalytical projects.
- Demonstrated experience mentoring, coaching, and providing technical leadership to junior scientists and colleagues.
- Demonstrated direct sponsor/client interaction, technical presentation, and meeting leadership experience; ability to build and maintain effective client relationships.
- Strong hands-on experience in at least one of the following: pharmacokinetics (PK), pharmacodynamics (PD)/biomarkers, or ADA assay development.
- Understanding of FDA and ICH guidelines in method development, validation and sample analysis.
- Prior experience working in a regulated GLP-compliant environment.
- Experience in two or more immunoassay techniques (Ligand Binding assay: ELISA, MSD, Gyrolab, AlphaLISA, ELISpot).
- Experience using Watson LIMS is preferred.
- Excellent verbal, presentation, and technical writing skills, with the ability to communicate effectively with scientists, clients, and stakeholders across disciplines and levels of expertise.
- Ability to work effectively within a team and with staff in other teams/locations, while demonstrating strong interpersonal, influencing, and collaboration skills.
- Ability to evaluate, recommend, and implement new technologies, platforms, or methodologies as appropriate.
- Experience with computer system validation (CSV) and/or User Acceptance Testing (UAT).
- Experience serving as an SME for authoring, revising, and implementing SOP content.
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