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Cell Based Potency Assay Jobs in Washington (NOW HIRING)

... cell-based and biochemical assays for biological therapeutics. The researcher will support ... Experience developing potency, functional, or mechanism-of-action bioassays for biologics ...

Bioassay Researcher

Silver Spring, MD · On-site

$85K - $141K/yr

... cell-based and biochemical assays for biological therapeutics. The researcher will support ... Experience developing potency, functional, or mechanism-of-action bioassays for biologics ...

QC Manager

Germantown, MD · On-site

$95K - $120K/yr

Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc. DESIRED KEY COMPETENCIES : * Demonstrated ability to manage a team and work independently on projects, and ...

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Cell Based Potency Assay information

What are some common challenges faced when developing and validating cell based potency assays in a laboratory setting?

Developing and validating cell-based potency assays can be challenging due to the inherent biological variability of living cells, which can impact assay reproducibility and consistency. Additionally, optimizing assay conditions—such as cell passage number, incubation times, and reagent quality—requires careful attention to detail. Collaboration across multidisciplinary teams, including scientists, quality control, and regulatory affairs, is often necessary to ensure the assay meets rigorous industry and compliance standards. Successful candidates should be comfortable troubleshooting technical issues and adapting protocols to achieve reliable results.

What are the key skills and qualifications needed to thrive as a cell based potency assay scientist, and why are they important?

To excel as a Cell Based Potency Assay Scientist, you need a solid background in cellular biology, assay development, and quantitative analysis, usually supported by a degree in life sciences or a related field. Familiarity with laboratory instruments like flow cytometers, plate readers, and proficiency in data analysis software such as GraphPad Prism are typically required, along with knowledge of GMP/GLP standards. Attention to detail, strong problem-solving abilities, and effective communication skills are essential soft skills in this role. These competencies ensure accurate assay results, regulatory compliance, and clear collaboration with cross-functional teams in biopharmaceutical development.

What are cell based potency assays?

Cell based potency assays are laboratory tests that use living cells to measure the biological activity of a drug, vaccine, or biologic product. These assays help determine how effective a compound is in producing a desired cellular response, making them crucial for drug development and quality control. By closely mimicking the drug’s mechanism of action in the body, they provide more relevant information about efficacy and safety compared to non-cellular assays.

What is the difference between Cell Based Potency Assay vs Cell Culture Technician?

AspectCell Based Potency AssayCell Culture Technician
Primary ResponsibilitiesAssessing the biological activity of products using cell-based methodsMaintaining and preparing cell cultures for various experiments
Required SkillsKnowledge of assay development, data analysis, cell biology techniquesCell culture techniques, aseptic handling, media preparation
Work EnvironmentLaboratories focused on assay validation and quality controlCell culture labs, manufacturing, or research facilities
Common CertificationsBiotech or laboratory certifications, cell biology trainingCell culture training, laboratory safety certifications

While both roles involve working with cells, the Cell Based Potency Assay specialist focuses on developing and performing assays to measure product activity, whereas the Cell Culture Technician primarily prepares and maintains cell cultures. The assay role requires analytical skills and assay-specific knowledge, while the technician role emphasizes cell handling and maintenance skills.

What job categories do people searching Cell Based Potency Assay jobs in Washington look for? The top searched job categories for Cell Based Potency Assay jobs in Washington are:
What cities in Washington are hiring for Cell Based Potency Assay jobs? Cities in Washington with the most Cell Based Potency Assay job openings:

hESC Associate Scientist_Scientist levels I or II

Workforce Genetics

Germantown, MD

Full-time

Posted 24 days ago


Job description

Embryonic Stem Cell Associate Scientist/Scientist I/II


Our client is seeking a highly skilled Associate Scientist/Scientist to contribute to their efforts in embryonic stem cell biology and early development processes. This role involves hands-on work with human pluripotent stem cells, development of differentiation protocols and stem cell-based solutions, and application of advanced analytical methods to study lineage specification and embryogenesis. The successful candidate will design, execute, and optimize experiments, interpret complex datasets, and collaborate closely with multidisciplinary teams to advance our scientific and translational objectives, deepen our understanding of embryonic stem cell development, facilitate next-generation therapeutic platforms, and help drive high-quality, reproducible science in a fast-paced, cross-functional environment.


Education:

  • BS/MS in Stem Cell Biology, Developmental/Cell Biology, Embryology, Molecular/Cell Biology, Reproductive Biology, or related fields. A master’s degree is preferred. Ph.D.’s with requisite experience will also be considered for this position.
  • 3+ years of relevant industry experience.
  • Prior experience in biotech, GMP, or regulated lab environments is strongly preferred.
  • Demonstrated expertise in applied research, translational projects, process development, and a strong product‑oriented approach.
  • Certification as a stem cell professional (CSCP) is optional but not a requirement.


Responsibilities:

  • Expand and maintain human embryonic stem cells (hESCs) under feeder-free and feeder-based conditions, including media optimization and validation.
  • Develop 2D and 3D (organoid) cell cultures.
  • Ensure stable pluripotency, perform routine passaging, and prevent spontaneous differentiation.
  • Execute and optimize differentiation protocols into specific lineages (endoderm, mesoderm, ectoderm).
  • Perform colony picking, clonal expansion, and establish new and stable hESC lines.
  • Scale up hESC cultures from research grade to clinical grade production (suspension, bioreactors, automation-ready systems).
  • Apply knowledge of early embryo development (cleavage to blastocyst), germ layer formation, and lineage specification.
  • Characterize stem cells using flow cytometry for pluripotency and lineage markers. Potency assay development. Immunostaining assays. qPCR, and gene expression profiling. Protein assays (Western blotting and ELISA). Fluorescence or confocal microscopy and live-cell imaging. Single-cell RNA-Seq and other omics platforms.
  • Assess genomic stability through karyotyping and related assays.
  • Analyze experimental data using appropriate software and statistical tools (e.g., FlowJo, ImageJ, GraphPad Prism, etc.).
  • Design, express, and troubleshoot mRNA constructs; perform transfections for transient gene expression, optimize delivery methods for high efficiency, isolate clones, and express and validate encoded proteins in hESCs.
  • Create and maintain master and working cell banks.
  • Conduct QC assays for viability, identity, sterility, and contamination control (e.g., bacteria, mycoplasma).
  • Optional: Optimize culture system, differentiation protocols under defined conditions, and assay workflows.
  • Work within GLP/GMP guidelines for stem cells and their derived products when applicable.
  • Ensure compliance with ethical and regulatory requirements for hESC research.
  • Design, execute, and troubleshoot complex experiments independently.
  • Maintain accurate lab notebooks and documentation, and follow SOPs and quality systems.
  • Present data clearly in meetings, reports, and cross-functional reviews.
  • Lead independent research projects and contribute to scientific strategy.
  • Support white paper/manuscript preparations and conference presentations as needed.

Technical expertise:

  • Experience with translational research or clinical trials involving embryonic stem cells and developmental embryology.
  • Proficient in the isolation and derivation of hESC lines, characterization using analytical and molecular assays, and karyotyping/genomic stability analysis.
  • Familiarity with key signaling pathways, including Wnt, BMP, FGF, TGF-b.
  • Knowledgeable in clonal isolation, screening, and validation; transfection and transduction methods; and cryopreservation, thawing, stability testing, and recovery of hESCs.
  • Strong understanding of ethical guidelines overseeing hESC research.
  • Familiarity with Institutional Review Board (IRB) processes and institutional compliance requirements.
  • Knowledge of national and international stem cell regulations (NIH and FDA guidelines) and regulatory expectations for clinical grade ESC/iPSC products (identity, purity, potency assays).
  • Experienced in contributing to IND-supporting studies and ethical compliance in human and animal research.
  • Understanding of FDA regulatory frameworks, CMC and batch records, and SOP development, optimization, and documentation.
  • Strong collaboration skills with various teams and clear, effective scientific communication, including data presentation and detailed reporting.
  • Demonstrated problem-solving ability and expertise in troubleshooting complex experimental workflows.
  • Experience mentoring junior scientists or technicians.
  • Exceptional attention to detail, essential for embryonic stem cell workflows.
  • Ability to present research outcomes and contribute to white papers/manuscripts.
  • Demonstrate project management capabilities and work within timelines and budgets.
  • Proficient in aseptic techniques and experienced working in BSL-2 environments.
  • Competence in experimental design and data analysis.