| Job Description | We are looking to add a Method Development Scientist in our Immunochemistry department at Covance. As a Scientist you will undertake original research that includes developing highly sensitive, reliable immunoassay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues. Additional responsibilities include:
Perform complex bioanalytical methods on biological matrices, often involving problem solving situations.
Apply and interpret scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies and accept a leadership role in developing scientific approaches
Act as research scientist, in a team work setting, for technical direction on complex bioanalytical projects
Produce reports for reliable, sensitive, and validated methods of analyses.
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Provide technical/scientific guidance and leadership to the study team as well as other areas of the company to ensure project completion.
Author scientific papers which are published in peer reviewed journals.
Participate in client visits.
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covances impressive history of company stability and growth. Weve achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. In the role described below, you will have the opportunity to shape the evolution of a growing business. We are looking for a candidate with a thorough knowledge of the scientific field, who can collaborate with others and direct their own efforts with a drive to succeed.
We are looking for the best to lead the best. As one of the worlds largest and most comprehensive drug development service companies, we respond to pharmaceutical and biotechnology clients' toughest drug development challenges. Covance has achieved impressive growth through our talented team's dedication to bringing the miracles of medicine to market
Education/Qualifications Required Education:
Ph.D in Biochemistry, Chemistry or Biology with 1-2 years of related industry experience.
MS degree plus 8-10 years of related hands-on laboratory experience.
Experience Required Experience:
Proven track record of immunoassay method development.
Prior experience working in a regulated GLP compliant environment.
Skilled in conducting research, compiling data, data interpretation, and writing reports according to regulatory requirements.
Skilled in performing scientific presentations and preparing scientific publications.
Highly Desired Experience:
CRO experience.
Hands on experience in one or more immunoassay techniques (Ligand-binding assay: ELISA, MSD, Biacore and/or RIA applicable to Pharmacokinetic and Immunogenicity studies.
Hands on experience developing cell-based assays applicable to Pharmacokinetic and Immunogenicity studies.
Experience developing and validating Immunogenicity (anti-drug antibody assays).
Familiarity with FDA Bioanalytical method validation guidance, and industry guidance on Immunogenecity method validation.
Prior hands on experience working with cell based assays as it relates to monoclonal assays.
Knowledge of Laboratory Automation and Data Reduction Software (e.g. Softmax, StatLIA etc) and LIMS systems (e.g. Watson).
Experience with MSD or Electrochemiluminescent (ECL) Immunoassay. |
| | Company | | Covance, Inc | Job Code | | State or Province | | Virginia | | |
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