Clinical Laboratory Scientist II

Clinical Laboratory Scientist II

Job ID: req4369
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Generic Location
Location: 10903 New Hampshire Ave , Silver Spring, MD 20993 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPDs ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPDs support services are aligned with the programs mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus disease and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPDs collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPDs mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Clinical Research (DCR) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. Specifically, CMRPD will provide bioanalytical research services in support of the DCR Special Projects. This includes services intended to support the scientific and research aims of NIAID DCR with a focus on research assay development, optimization, and research laboratory testing of human biospecimens.

KEY ROLES/RESPONSIBILITIES

• Support clinical research to develop and optimize new assays, techniques and programs that involve the use of various robotics and automated platforms.
• Adopt, optimize, and schedule multiplex binding assays such as the Ebola-Detect Assay.
• Schedule, document, and maintain reagents lines for assays.
• Follow approved standard operating procedures to complete testing of samples in an organized, aseptic, high-throughput manner.
• Work collaboratively with team members and collaborators to complete all tasks for the day but also be accountable as an individual for personal tasks.
• Uphold rapid turn-around times of specimen samples by effectively managing resources while maintaining high standards of accuracy.
• Utilize various laboratory equipment such as Biological Safety Cabinet (BSC), centrifuge, pipettes, liquid nitrogen tank, and others.
• Work with dry ice, freezers, and liquid nitrogen tanks to store clinical samples, and perform clinical testing in a BSL-2 environment while always wearing appropriate PPE.
• Assists in standard operating procedure development and documentation for assay validation and verification
• Provide expertise performing serology assays.
• Provide expertise working with automated liquid handlers.
• Provide scientific leadership, mentoring and training to peers.
• Serves as a participating member of a research team and is responsible for locating and reviewing the literature pertinent to the project to identify the most applicable protocols and methods
• Manages the day-to-day operation of the supported laboratories, including coordinating activities of diverse laboratory research projects and ensuring availability of equipment and supplies
• Provides subject matter expertise on all aspects of clinical research supporting endpoint assays, including sample collection, processing, shipping, review of assay qualification and validation reports, specimen testing
• Works through issues about supplies, testing, etc.
• Identifies, tracks, and resolves issues at endpoint assay labs
• Works with laboratory staff to ensure that laboratory equipment is available as needed, properly calibrated, and in working order
• Reviews and recommends new equipment, schedules demonstrations, and initiates procurement. Participates in planning for future equipment needs
• Develops lists of reagents and consumables for assays and research needs
• Provides support to the development and implementation of various technical and logistical tracking systems to meet research and operational needs across the high-profile clinical research projects
• May supervise staff
• This position will be located at the FDA research facility in Silver Spring, MD
• This position is for 12 months or until 8/30/2026

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a PhD from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/biology/microbiology Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of two (2) years of experience in laboratory research, including experience in a BSL-2 laboratory
• Experience related to clinical laboratory operations (e.g., development of Standard Operating Procedures [SOPs], validation and verification of new assays, expertise in laboratory equipment
• Must be detail oriented. Possesses strong verbal communication, writing and organizational skills, including the ability to prioritize multiple tasks and projects
• Ability to work well under pressure, apply technical expertise, and make sound decisions
• Flexibility and willingness to adapt in a changing environment
• Ability to work independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance.
• Ability to make administrative and procedural decisions.
• Comprehensive knowledge of laboratory procedures for clinical research laboratories
• Proficiency in Windows and Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook
• Ability to travel up to 10% domestically and internationally.
• Must be able to obtain and maintain a security clearance

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Familiarity with Good Laboratory Practices (GLP)
• Familiarity with management of biosepcimens and laboratory supplies
• Clinical research with infectious disease experience, preferably with filoviruses
• Experience performing serology assays, working with automated liquid handlers.
• Experience with reviewing data for safety signals
• Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks

JOB HARZARDS OR REQUIREMENTS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

100,400.00 - 172,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions