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Cell Based Potency Assay Jobs (NOW HIRING)

Cellares

Quality Control Analyst

Bridgewater, NJ · On-site

$90K - $210K/yr

Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.) * Perform timely and accurate peer review of ...

Lumencor

Cell-Based Assay Scientist

Beaverton, OR · On-site

$36.75 - $46/hr

The Cell-Based Assay Scientist uses specialized laboratory skills and technical knowledge to support Lumencor's hardware, software and reagent products related to cell-based assays. These activities ...

Cellares

Quality Control Analyst

Bridgewater, NJ · On-site

$90K - $210K/yr

Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.) * Perform timely and accurate peer review of ...

Cellares

Quality Control Analyst

Bridgewater, NJ

$90K - $210K/yr

Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.) * Perform timely and accurate peer review of ...

Lumencor

Cell-Based Assay Scientist

Beaverton, OR · On-site

$36.75 - $46/hr

The Cell-Based Assay Scientist uses specialized laboratory skills and technical knowledge to support Lumencor's hardware, software and reagent products related to cell-based assays. These activities ...

Novartis

Associate Expert Potency

East Hanover, NJ · On-site

$84K - $126K/yr

Participate in method development and qualification of cell-based potency assays suitable for both in-process and drug product (DP) lot release and quality attribute assessment for AAV and LVV viral ...

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All JobsCell Based Potency Assay Jobs

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.

More about Cell Based Potency Assay jobs
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Cell Based Potency Assay jobs near you
Infographic showing various Cell Based Potency Assay job openings in the United States as of July 2026, with employment types broken down into 38% Locum Tenens, 6% Internship, 44% Full Time, 2% Part Time, 1% Contract, and 9% Summer. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.
Director, Analytical Development (Flow Cytometry & Method Validation)

Director, Analytical Development (Flow Cytometry & Method Validation)

Orca Bio

Sacramento, CA

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 days ago

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
 
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

Summary:

In this Sacramento-based role, reporting into our VP/Head of CMC, you will lead the design, development, validation, and lifecycle management of analytical methods supporting cell therapy programs. This role will provide strategic and technical leadership with a strong emphasis on advanced flow cytometry, method validation, and cell-based assays. The ideal candidate brings deep expertise in cell therapy analytics, a proven track record in regulatory submissions, and demonstrated success in building and leading high-performing scientific teams.

Responsibilities

Leadership & Strategy

  • Provide scientific and operational leadership for the Analytical Development function supporting cell therapy programs.
  • Build, mentor, and lead a team of scientists specializing in flow cytometry, cell-based assays, and analytical characterization.
  • Define and execute analytical strategies aligned with program, regulatory, and commercialization timelines.
  • Collaborate cross-functionally with Process Development, Manufacturing, Regulatory Affairs, QC, and Clinical teams.
  • Develop methods related to raw material testing and microbial release tests.

Flow Cytometry & Cell Therapy Expertise

  • Lead the development, optimization, and qualification of multiparametric flow cytometry assays for cell identity, purity, potency, and phenotypic characterization.
  • Establish standardized panels, controls, and gating strategies for complex cell therapy products (e.g., CAR-T, TCR-T, stem cell-derived therapies).
  • Drive innovation in high-dimensional cytometry and data analysis approaches.

Analytical Method Development & Validation

  • Oversee development, qualification, transfer, and ICH-compliant validation of analytical methods.
  • Ensure assays meet regulatory expectations for precision, accuracy, specificity, robustness, and stability.
  • Lead comparability studies, reference standard programs, and method lifecycle management.
  • Establish an efficient strategy for method validation and transfer.

Regulatory & Compliance

  • Author and review analytical sections of IND, BLA, and other regulatory submissions.
  • Serve as a technical subject matter expert during regulatory agency interactions.
  • Ensure compliance with cGMP, GLP, and regulatory guidelines.

Operational Excellence

  • Drive continuous improvement in assay robustness, throughput, and scalability.
  • Manage budgets, timelines, and resource allocation across multiple programs.
  • Oversee technology transfer to Quality Control laboratories.
Required Qualifications

Education & Experience

  • Ph.D. in Immunology, Cell Biology, Analytical Chemistry, or related field required
  • Minimum 10+ years of industry experience in biotech or pharma
  • 8+ years' experience in experience in cell therapy analytical development (e.g., CAR-T, gene-modified cells, stem cells)
  • MSc degree acceptable with 15+ years of relevant experience

Technical Expertise

  • Deep expertise in flow cytometry assay development (multicolor panels, intracellular staining, rare cell detection, functional assays)
  • Strong background in analytical method validation (ICH Q2 and regulatory expectations)
  • Experience with cell-based potency assays
  • Familiarity with advanced cytometry technologies (e.g., spectral cytometry, CyTOF) is a plus
  • Strong understanding of CMC development for biologics and cell therapies

Leadership Skills

  • Proven experience leading and developing high-performing teams
  • Strong project management and cross-functional leadership skills
  • Ability to influence stakeholders at all organizational levels
  • Strategic thinking and scientific rigor
  • Strong communication and presentation skills
  • Results-driven with a focus on quality and compliance
  • Ability to manage complexity in a fast-paced environment
Preferred Qualifications
  • Experience supporting late-stage clinical programs or commercial products
  • Prior experience interacting with FDA/EMA regulatory agencies
  • Experience in data analysis tools (FlowJo or equivalent)
  • Knowledge of automation and digital data systems in analytical labs
$175,000 - $215,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
 
Who we are
 
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
 
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
 
We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo.
 
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
 
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
 
Notice to staffing firms
 
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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