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Senior Method Development Scientist-Large Molecule Bioanalysis

Company: Covance
Location: Chantilly
Posted on: June 6, 2021

Job Description:

We have an exciting opportunity for aMethod Development SR. Staff Scientistto join our team inChantilly, 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!

This role:
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:
- Performs research involved in developing de-novo and/or method transfers of highly sensitive, proprietary Ligand Binding Assays (ELISA-based immunoassays) for accurate and precise analysis of large molecule therapeutics in biological fluids and tissues
- Can perform multiple complex bioanalytical methods in parallel
- Is familiar with developing or qualifying immunoassay methods in a drug development phase-appropriate manner to support either pre-clinical or clinical studies for various therapeutic modalities including but not limited to: Monoclonal Antibodies, Bi-specific Antibodies, Peptides, Peptide Conjugates, Recombinant Human Proteins, Antibody-Drug Conjugates, Gene and Cell-Therapy Products and other large molecule therapeutics
- Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in the bioanalysis of large molecule therapeutics in developing and/or improving existing approaches to support Pharmacokinetic/Pharmacodynamic quantitative measurements or detection and characterization of Anti-Drug Antibodies
- Acts as a research scientist, in a collaborative manner, to provide technical direction to downstream colleagues (e.g., Method Validators, Lead Scientists, & Project Managers) in the application of various methods
- Responds to requests, client needs, crises, etc., without neglecting other duties for prolonged periods of time
- Can author and contribute to Method Development Reports
- Is highly competent at presenting scientific content involving Method Development approaches in weekly or bi-weekly client communication meetings
- Can author or contribute to scientific papers and/or posters which are published in peer reviewed journals or presented at bioanalysis focused conferences
- Can contribute ideas to process improvement of method development workflow
- 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.

Keywords: Covance, Chantilly , Senior Method Development Scientist-Large Molecule Bioanalysis, Other , Chantilly, Virginia

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