Excellent opportunity for an experienced Method Development Staff Scientist
to join our rapidly growing team in Chantilly, VA
. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide.
Join us, as we partner with leading pharmaceutical and biotechnology companies globally to deliver new medicines to improve public health. This role:
Researches and develops state-of-the-art bioanalytical methods for the assessment of pharmacokinetics, pharmacodynamics and immunogenicity of novel bio-pharmaceutical compounds in biological matrices using a fundamental knowledge of ELISA based immunochemistry principles applied to a variety of technology platforms such MesoScale Discovery™, and in a manner consistent with current regulatory expectations for bioanalysis. The method development staff scientist supports multi-disciplined studies, generates critical scientific results, solve problems, communicates with clients and internal stakeholders and interprets data of a scientific nature. ESSENTIAL JOB DUTIES:
- Undertakes research that includes developing and transferring of highly sensitive, reliable immunoassay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues.
- Performs complex analytical methods on biological matrices, often involving problem solving situations.
- Is familiar with developing or qualifying immunoassay methods in a phase appropriate manner to support either pre-clinical or clinical studies.
- Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in the bioanalysis of large molecule therapeutics and accepts leadership role in developing scientific approaches.
- Acts as lead research scientist, in a team work setting, for technical direction on complex bioanalytical projects.
- Responds to unscheduled deadlines, client needs, crises, etc., without neglecting other duties.
- Produces method development reports for reliable, sensitive, and qualified methods of analyses.
- Authors scientific papers or posters which are published in peer reviewed journals or presented in bioanalysis focused conferences.
- Participates in client visits.
- Contributes to long-range planning and technical policies of the department.
- Performs other related duties as assigned.
- Primarily a bench-based position, however will be expected to participate in meetings/client communications/conference as needed
- MS, (preferably PhD) in chemistry, or equivalent degree, with 2-5 years of industry related experience. Relevant experience may be substituted for education.
- Experience and knowledge of analytical various ELISA based platforms (e.g. ELISA, Meso-Scale Discovery™).
- Proven track record of method development and troubleshooting using de-novo approaches or transfer of qualified/validated plate based immunoassays utilizing various assay formats (e.g., Direct, Indirect, Sandwich, Bridging, etc.,)
- Exprience with Cell-Based Assays is a plus, but not required.
- Skilled in conducting research, compiling data, data interpretation, and writing reports according to FDA & EMA Bioanalytical Method Validation & Immunogenicity regulatory requirements.
- Skilled in performing scientific presentations and preparing scientific publications.
- Knowledge of laboratory automation software, system software, and Microsoft applications.
- Effective oral and written communication skills.
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