Job ID: req4575
Employee Type: exempt full-time
Division: Clinical Research Directorate
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 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.

Program Description

The BioProcessing and Trial Logistics (BPTL) functional team within the Cancer Genomics Research Laboratory (CGR) plays a critical role in supporting the National Cancer Institute (NCI) Division of Cancer Epidemiology and Genetics (DCEG) through expert oversight of biospecimen operations for a variety of research aims. By integrating laboratory operations, biospecimen processing, inventory management, and site coordination, BPTL helps ensure that specimens are collected, processed, stored, tracked, and documented with the highest standards of quality and integrity.

Key Roles/Responsibilities

Responsibilities

• Oversee day-to-day laboratory operations for the BPTL functional team in support of DCEG research activities

• Provide operational supervision and leadership to Research Associate III and Research Associate IV staff, including direction-setting, prioritization of work, coordination across teams, and support for staff development and performance

• Coordinate with existing Connect program management within BPTL as well as the DCEG Connect scientific leadership to ensure appropriate support for biospecimen accrual needs

• Manage biospecimen processing workflows, including receipt, accessioning, processing, aliquoting, storage, and shipment coordination

• Document and communicate collection and processing deviations, coordinate appropriate corrective actions in collaboration with the BPTL Connect program manager and QA staff, and support preventative action implementation with CGR/BPTL leadership.

• Provide needed support to ensure accurate and timely biospecimen inventory management within laboratory databases

• Collaborate with program management and CGR leadership to ensure time-sensitive specimens are handled according to protocol requirements, chain-of-custody expectations, and quality standards

• Coordinate operational priorities across teams and shifts to maintain workflow continuity, staffing coverage, throughput, and laboratory readiness

• Prepare and maintain accurate laboratory records, specimen tracking logs, reports, and other study documentation

• Collaborate with CGR leadership and Connect program management to review laboratory workflow performance, specimen tracking records, shipment documentation, inventory data, and operational reports to identify discrepancies, trends, risks, and opportunities for improvement.

• Coordinate with DCEG and CGR/BPTL leadership to support study needs, operational priorities, and evolving program requirements, including new biospecimen collections as study needs evolve

• Support implementation and continuous improvement of laboratory workflows using CGR’s established quality management systems and high-throughput operational infrastructure including documentation of deviations and authorship and review of standard operating procedures

• Support laboratory quality assurance activities, equipment oversight, supply management, and general laboratory organization

• Train and guide laboratory staff on safe biospecimen handling procedures, documentation practices, and protocol-specific requirements as needed

• Use Excel, Word, Outlook, and laboratory information systems daily for tracking, reporting, communication, and operational management

• Contribute to the successful scale-up of active or new studies through strong coordination, collaboration, prioritization, and data oversight

Basic Qualifications

• Bachelor’s degree from an accredited college/university recognized by the Council for Higher Education Accreditation (CHEA) in a relevant scientific discipline, or four (4) years of relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency

• In addition to the education requirement, a minimum of eight (8) years of relevant laboratory experience with human biospecimens and progressively increasing responsibility in laboratory operations and staff management, specimen management, or clinical research support

• Demonstrated experience overseeing laboratory operations involving human biospecimens, including specimen processing, inventory management, blood fractionation, chain-of-custody procedures, and documentation requirements in research, clinical, or biorepository settings.

• Experience with laboratory data management and specimen tracking systems

• Strong interpersonal and cross-cultural communication skills, with the ability to work effectively with internal leadership and external collection sites

• Experience coordinating multiple activities in a fast-paced, deadline-driven environment

• Proficiency with Microsoft Office Suite, including Excel, Word, Teams and Outlook

• Demonstrated organizational, documentation, and problem-solving skills

• Demonstrated ability to manage data accurately in a fast-paced environment

• Ability to obtain and maintain a security clearance

Preferred Qualifications

• Previous experience overseeing staff and laboratory operations in support of multi-site clinical research or consortia-based specimen collection programs

• Experience with biospecimen inventory management databases, laboratory information management systems (LIMS), or electronic laboratory notebooks (ELNs)

• Familiarity with quality management systems in a regulated or high-throughput laboratory environment

• Experience supporting scale-up of specimen collection operations for active or expanding clinical studies, including experience with automated liquid handling instrumentation

• Experience with specimen shipping/logistics, kit management, and chain-of-custody documentation

• Demonstrable experience reviewing laboratory operational data and using metrics to support workflow improvement

• Knowledge of basic biorepository operations

• Previous experience training and mentoring staff in laboratory procedures and documentation practices

• Demonstrated ability to communicate effectively with scientific, operational, and administrative stakeholders

• Strong data management skills and attention to detail

JOB HAZARDS

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

• Work will involve Biosafety Level II laboratory conditions as well as standard office/administrative conditions.

• Work may involve the use of potentially hazardous chemical or biological materials or may be in areas where such materials are used, requiring the use of personal protective equipment and adherence to strict safety protocols.

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. Salary range: 93,800.00 - 156,875.00 USD. 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.