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 II, Clinical Pharmacodynamic Assay Reagent Quality Control Manager, will:
- Manage a quality control laboratory responsible for performing incoming quality control testing on critical reagents for validated clinical pharmacodynamic assays across several technology platforms (i.e., multiplex immunofluorescence assays on slide based clinical biopsy analyses and circulating tumor cells; ELISA and Luminex assays on extracted clinical biopsies and cellular extracts, etc.
- Oversee the procurement of bulk quantities of antibodies and other critical reagents and oversee their analytical and performance testing and subsequent release according to established reagent and clinical assay specifications
- Oversee the production and release of custom assay control and proficiency specimens
- Maintain a large inventory of assay critical reagents and associated electronic database
- Oversee the distribution of assay critical reagents to external and internal laboratories
- Supervise research associates in performing all laboratory operations, associated procurement and QC reporting activities
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. (Additional qualifying experience may be substituted for the required education).
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, at least two years of experience in assay reagent quality control and/or GMP manufacturing environment is required; post-doctoral training or experience is required for this position.
- Demonstrated experience in antibody analytical and performance characterizations.
- Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Experience with one or more of the following techniques: Sandwich ELISA, Luminex assays, slide based multiplex immunofluorescence assay staining and analysis methods, immunoassay development, antibody conjugation, protein purification, SDS-PAGE and Western blotting
- Ability to independently develop and modify methods and techniques
- Proficiency with Microsoft Office (Excel, Word, and PowerPoint)
- Experience working in a GxP environment. Quantitative laboratory work in biochemistry, biology, chemistry, biotechnology
- Experience in supervising laboratory staff from the entry technician level through associate scientist level bench scientists
- Experience in the following areas: antibody and protein analytical and performance quality control evaluations
- Experience in inventory of qualified assay reagents, including procurement, handling, testing and distribution
- Ability to provide day to day supervision of a small group of research associates
- Outstanding ability to collaborate with a diverse group of scientific staff responsible for initial development and validation of the clinical pharmacodynamic assays across several platforms and also core facilities providing testing support (histology, pathology, FFPE slide staining, whole slide image scanning, protein and antibody production, antibody conjugation, preclinical tissue generation, cell culture support, etc.).
- Ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports and presentations
- A record of publication in refereed scientific literature
- Ability to master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations; hands-on instrumentation work is required for this position
- Ability to maintain precise records
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.