To address rapidly changing program needs across several ongoing research projects within the Division of Applied Regulatory Science (DARS), the FDA requires scientists with experience across several different scientific disciplines including molecular biology. DARS currently requires a scientist with a high level of technical experience in molecular biology and DNA sequencing platforms.  The scientist will provide technical support to regulatory research in the Division of Applied Regulatory Science (DARS) located in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), FDA. DARS seeks to move new science into the regulatory review process and close the gap between scientific innovation and medical product review.

Multiple areas of regulatory research have been transformed by advances in molecular biology and the development of innovative technologies that enable comprehensive characterization of the genome, transcriptome, epigenome, and proteome. High-throughput molecular platforms, including next-generation sequencing (NGS), single-cell sequencing, and other omics technologies, have expanded opportunities for biomarker discovery and mechanistic investigations, supporting the identification of clinically meaningful differences in drug responses and biological systems.

The Division of Applied Regulatory Science (DARS) is actively evaluating emerging molecular and omics technologies to advance regulatory science and support the development, standardization, and validation of innovative assays for drug testing and safety assessment. These efforts contribute to the evaluation and implementation of New Approach Methodologies (NAMs) for regulatory applications.

The Molecular Biologist will provide scientific support for ongoing and emerging research programs within DARS. Responsibilities include conducting molecular biology studies using cell-based systems; performing mammalian cell culture, including three-dimensional (3D) spheroid models; extracting and characterizing nucleic acids from these cells and tissues using RT-qPCR arrays and/or sequencing; preparing libraries for sequencing platforms, including next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq); and performing bioinformatic and statistical analyses of data generated from these studies. The incumbent will also contribute to the development, validation, optimization, and implementation of innovative molecular and omics-based methodologies supporting DARS research.

Requirements

a. Participate in continuous quality improvement initiatives for laboratory processes and collaborate with laboratory staff to implement process improvements and best practices.

b. Work with the laboratory lead to develop, optimize, validate, and implement molecular biology methods and sequencing workflows that support omics-based analyses and the evaluation of New Approach Methodologies (NAMs), including array-based platforms, next-generation sequencing (NGS), and single-cell RNA sequencing (scRNA-seq). In collaboration with the laboratory lead, interpret molecular and omics-based data, communicate scientific findings, and contribute to technical reports and presentations.

d. Plan, develop, perform, document, and report all phases of method development, validation, technology transfer, and implementation of new or updated molecular biology and sequencing platforms.

e. Perform mammalian cell culture using suspension, adherent (2D), and three-dimensional (3D) culture systems, including spheroid models, to support assay development and mechanistic studies.

f. Troubleshoot laboratory methods, instrumentation, and sequencing workflows, proactively identifying and resolving technical challenges to ensure high-quality and reproducible data.

4. Position Requirements

Education and Experience: The position identified under this Task Order shall meet the labor category requirements defined in the base contract and the additional qualifications listed below.

Essential Requirements & Qualifications:

a. PhD in Molecular Biology, Cell Biology, Genetics, Genomics, Biotechnology, or closely related scientific discipline.

b. Strong technical and scientific background in contemporary molecular biology techniques and DNA/RNA sequencing technologies.

c. A minimum of five (5) years of post-graduation research laboratory experience.

d. Experience handling human biospecimens in a Biosafety Level 2 (BSL-2) laboratory environment.

e. Demonstrated ability to independently troubleshoot, optimize, develop, and validate molecular biology and sequencing methods.

f. Strong computer, scientific, analytical, and organizational skills; experience using Laboratory Information Management Systems (LIMS) is desirable.

g. Excellent written and verbal communication skills with strong attention to detail.

h. Demonstrated ability to work independently and collaboratively within multidisciplinary teams, while maintaining adaptability, initiative, and professionalism.

i. Ability to rapidly learn new technologies, manage multiple projects simultaneously, maintain accurate laboratory documentation, follow established procedures, and comply with Division and Center policies.

j. Authorization to work in the United States without restriction or the need for visa sponsorship.

Preferred Expertise (experience in some or all of the following):

a. Mammalian cell culture, including suspension, adherent (2D), and three-dimensional (3D) culture systems (e.g., spheroids and organoids).

b. RNA, DNA, and protein extraction, quantification, and quality assessment.

c. PCR, RT-qPCR, digital PCR, microarray, and other nucleic acid-based technologies.

d. DNA/RNA sequencing platforms, including next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) as well as experience with bioinformatic analysis is highly desirable

e. Genomic, transcriptomic, proteomic, and other multi-omics analyses.

f. In vitro drug testing and cell-based functional assays.

Benefits

• PPO/HMO Health Plan (includes medical, dental, and vision)
  
• 401K Retirement Plan
  
• Paid Time Off (PTO)