Bio Bioassay Researcher Comparison Matrix

Position: Bio Bioassay Researcher Candidate Comparison Matrix
## Bio Bioassay Researcher Candidate Comparison Matrix Apply:
US - MD, Silver Spring:
Full time:
Posted Today:
44962
** Job Family:
** Scientific Research & Analysis
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* Travel Required:

** None
*
* Clearance Required:

** None This role will support the FDA by performing laboratory-based experiments and providing scientific support for approved bioassay projects. The role will establish and characterize cell-based and biochemical assays used to evaluate biological therapeutics and will generate validated, reproducible research data in accordance with FDA laboratory standards and SOPs.

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* What You Will Do:

*** Culture and maintain identified immortalized cell lines under air-liquid interface conditions.
* Optimize transcytosis and permeation bioassays to evaluate apical-to-basal and basal-to-apical transport of monoclonal antibodies and other biological therapeutics across polarized epithelial cell layers.
* Validate bioassays for reproducibility, sensitivity, and specificity.
* Perform hands-on laboratory work using cell culture, qRT-PCR, ELISA, western blotting, immunohistochemistry, and other relevant in vitro and analytical techniques.
* Collect, process, analyze, and document laboratory data accurately and completely in accordance with FDA laboratory standards.
* Maintain electronic laboratory notebooks and experimental records on a rolling basis with no documentation gaps.
* Contribute to collaborative research activities, data analysis, scientific summaries, technical reports, presentations, and other written materials.
* Participate in interdisciplinary teams, scientific discussions, weekly research updates, ad hoc meetings, and knowledge-transfer activities.
* Immediately report safety incidents, near-misses, potential hazards, anomalous results, risks, issues, and concerns through the required FDA channels.
* Protect all government research information and data from unauthorized release.  
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* What You Will Need:

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* * Bachelor's Degree Required
* Minimum of four (4) years of hands-on laboratory experience in cell-based assay development and biological therapeutics research.
* Experience with mammalian cell culture and in vitro model systems.
* Experience with one or more relevant techniques, including qRT-PCR, ELISA, western blotting, immunohistochemistry, or comparable biochemical assays.
* Experience designing, optimizing, characterizing, and validating bioassays against defined performance criteria.
* Ability to produce scientifically sound, reproducible, and thoroughly documented experimental work and data.
* Strong laboratory documentation, data analysis, scientific writing, presentation, and technical communication skills.
* Ability to work onsite at the White Oak FDA Campus and comply with FDA facility access, safety, security, badging, and laboratory requirements.
* Ability to obtain a favorable Tier 1 background determination and PIV card. The solicitation does not specify a minimum degree or minimum years of experience.
** What Would Be Nice To Have:
*** Experience developing transcytosis or permeation assays using polarized epithelial cell layers and air-liquid interface conditions.
* Experience evaluating monoclonal antibodies, inhaled or intranasally delivered biological therapeutics, or other complex biological products.
* Familiarity with FDA or OPQR laboratory standards, SOPs, pharmaceutical quality research, or regulatory science.
* Experience collaborating with internal and external research partners and sharing laboratory methods and protocols.
* Experience preparing weekly research updates and final research summaries in Microsoft Word or PowerPoint.

The annual salary range for this position is $98,000.00-$. Compensation decisions depend on a wide range of factors, including but not limited…