We have an exciting opportunity for a Method Development Staff Scientist to join our team in Chantilly, VA. Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work!
Researches and develops bio-analytical methods for the assessment of pharmacokinetics, pharmacodynamics and immunogenicity of bio-pharmaceutical compounds in biological matrices using a fundamental knowledge of ELISA based immunochemistry principles applied to a variety of technology platforms such as Gyros™, Simoa™, Luminex™ and MesoScale Discovery™, and in a manner consistent with current regulatory expectations for bioanalysis. The method development staff scientist supports multi-disciplined studies, generates 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 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.
Why People choose to work at Covance?
At Covance, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends!
- 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™, Luminex™, Hamilton™ Liquid Handling Immunoassay modular automation Gyros™, Simoa™, etc.).
- 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.,)
- 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.
Posting ID: 584171231Posted: 2021-01-27