The Clinical Pharmacodynamic Program (CPP) is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute (NCI). The scope of work includes assay design, development, validation, fitness for purpose testing, transfer and support of assays to internal and external clinical laboratories, and clinical specimen analysis when required. The Internal Quality Control (IQC) laboratory within the CPP program is responsible for maintaining an inventory, quality control testing and distribution process for a large number of critical reagents to support the conduct of validated clinical pharmacodynamic assays across several technology platforms within network of internal and external laboratories.
The Scientist I will assist in the development, validation, and application of quantitative multiplex assays on the Luminex platform to be used in assessing patient response to new anti-cancer agents.
Other responsibilities include, but are not limited to, the following:
- Design ex vivo and in vivo experiments to test immunoassay reagents and efficacy of assays
- Design antigens for generation of antibodies
- Write statements of work for sub-contracted work
- Monitor development of monoclonal antibodies
- Produce and characterize recombinant proteins and/or peptides as calibrators
- Develop and validate multiplex immunoassays of pharmacodynamic biomarkers on luminex platform
- Insure adequate specificity and analytical characteristics of reagents
- Provide timely progress reports and prepare/perform presentations for management review
- Write abstracts/manuscripts for presentations in meetings and publication
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research.
- No experience is required beyond the doctorate degree
- Experience in development, production, and characterization of reagents used in immunoassays (i.e., antibodies and recombinant proteins)
- Proficient in Microsoft office software, electronic data keeping and management, and basic knowledge of statistics applied in data reduction and analysis.
- Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Experience after completing PhD in development and validation of sandwich immunoassays on Luminex platform
- Experience with the application of multiplex assays on the Luminex platform in preclinical and clinical studies
- Experience in monoclonal antibody development, production of recombinant proteins, protein purification techniques, and/or protein characterization
- Complex statistical analysis of multiplex data
- Experience in the development and validation of sandwich immunoassays on the Luminex platform
- Knowledgeable of techniques used in development, production, and characterization of reagents used in immunoassays such as antibodies and recombinant proteins
- Immunoassay data analysis and concepts in immunoassay quality control/good laboratory practice standards
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.