Bioassay Research Scientist II

About the role

The researcher will support laboratory-based experiments focused on NF-κB activity and signal detection strategies. This work supports regulatory science objectives related to potency assay development for biological products whose mechanisms of action depend on modulation of specific subunits.

Responsibilities

• Perform mammalian cell culture, cell line engineering support, and maintenance of relevant human cell lines used as bioassay substrates.
• Develop, optimize, and support qualification of cell-based bioassays capable of detecting total NF-κB activity and subunit-specific NF-κB activity, with emphasis on c-Rel-specific bioassays for comparative analysis studies.
• Process, analyze, interpret, and document experimental data in accordance with project plans, laboratory standards, and applicable quality expectations.
• Prepare technical reports, scientific summaries, presentations, and final project documentation describing experimental procedures, data analysis, findings, and conclusions.
• Support manuscript preparation and dissemination of scientific findings through internal and external scientific presentations or conferences.
• Maintain complete and accurate laboratory notebooks, experimental records, methods, data files, and supporting documentation.
• Participate in interdisciplinary scientific collaborations with regulatory staff and other project stakeholders to advance public health objectives.
• Provide project updates, progress summaries, issue identification, and recommendations to support effective project execution.

Requirements

• Ph.D. degree in molecular biology, cell biology, or a closely related scientific field.
• Minimum two (2) years of relevant research experience in general molecular biology, cell-based assay development, bioassay characterization, and experimental design and mammalian cell culture techniques.
• Experience designing and executing scientific studies independently with high-level guidance from project leaders.
• Experience conducting data collection, analysis, and preparation of scientific manuscripts, technical reports, or research summaries.
• Ability to process, interpret, and clearly communicate complex scientific data to technical and non-technical stakeholders.
• Excellent written and oral communication skills, including experience preparing technical reports and scientific presentations.
• Ability to work effectively in a collaborative laboratory research environment and support regulatory science objectives.

Qualifications

• Experience developing, optimizing, qualifying, or validating bioassay methods for biological products, biotechnology products, biosimilars, or complex therapeutics.
• Experience developing potency, functional, mechanism-of-action, or subunit-specific bioassays (i.e. NF-κB, c-Rel, RelA, RelB, p50, p52) and analyzing inflammatory and oncology-related signaling pathways.
• Familiarity with ICH, USP, FDA, GLP, ISO, or equivalent laboratory quality standards.
• Experience preparing manuscripts, scientific posters, regulatory science reports, white papers, or conference presentations.
• Prior experience supporting FDA, HHS, NIH, or other public health or regulatory science research programs.

Skills

• Strong laboratory skills, including mammalian cell culture techniques and bioassay development.
• Proficiency in data analysis and interpretation.
• Effective communication skills, both written and verbal.
• Collaborative and team-oriented approach.

Benefits

The annual salary range for this position is $65,000.00-$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Pay

The annual salary range for this position is $65,000.00-$108,000.00.

Schedule

Full-time, 40 hours per week.