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
Skills Required
- Bachelor's degree in Biochemistry, Chemistry, or Biology
- Proven proficiency in immunoassay development and ability to manage multiple projects
- Strong hands-on experience in at least one of: PK, PD/biomarkers, or ADA assay development
- Experience in one or more immunoassay techniques: ELISA, MSD, Gyrolab, AlphaLISA
- Understanding of FDA and ICH guidelines for method validation and sample analysis
- Excellent verbal and technical writing skills and presentation ability
- Ability to work effectively within cross‑functional teams and with distributed staff
- 5+ years of related scientific experience
- Advanced degree (MS/PhD)
- Prior experience in a regulated GLP-compliant environment
- Experience using Watson LIMS
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
