Scientist, Method Development - ELISA & MSD

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