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Cell Based Potency Assay Jobs (NOW HIRING)

Parexel

Scientist III - Potency Assay - FSP

Three Rivers, MI · On-site

$32.50 - $40.75/hr

Execute cell-based potency assay sample testing following written analytical procedure * Ensure work is recorded in an electronic document in a real-time manner that is clear and concise and ...

US Tech Solutions

R&D Scientist

Lake Forest, IL

Develop and qualify precise ELISA, CRBA and cell-based potency methods for analysis of large ... Perform characterization sample testing, statistical data analysis and summarize assay results ...

Alcami Corporation

Sr. Scientist I - Bioassay

Durham, NC

$82K - $113K/yr

The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing ...

Alcami Corporation

Sr. Scientist I - Bioassay

Wilmington, NC · On-site

$83K - $114K/yr

The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing ...

Alcami Corporation

Sr. Scientist I - Bioassay

Durham, NC

$82K - $113K/yr

The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing ...

Alcami Corporation

Sr. Scientist I - Bioassay

Wilmington, NC · On-site

$83K - $114K/yr

The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing ...

Alcami Corporation

Sr. Scientist I - Bioassay

Durham, NC · On-site

$82K - $113K/yr

The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing ...

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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.

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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 June 2026, with employment types broken down into 2% Internship, 27% As Needed, and 71% Full Time. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Senior Scientist, Cell-Based Potency Assay Development

RecruitSeq

South San Francisco, CA • On-site

$110K - $150K/yr

Other

This job post has expired today. Applications are no longer accepted.

Job description

Scientist I/II/Sr, Bioanalytical Assay Development

South San Francisco, CA


Our client is an emerging gene therapy biotech developing next‑generation therapeutics using cutting‑edge gene engineering platforms. The company is advancing a pipeline of preclinical and early clinical programs targeting serious unmet medical needs.


We are hiring a Scientist who will work on the bioanalytical strategy across preclinical and clinical programs, from assay design through regulatory submission support. You will support development, qualification, and validation of PK/PD, biomarker, and potency assays, manage external partners, and serve as a key interface between Research, Development, and Regulatory to drive data‑driven decisions.



Responsibilities



  • Design, develop, and execute bioanalytical assays to support preclinical and clinical studies, including PK/PD and biomarker assessments
  • Perform routine and complex experiments, analyze data, and clearly document results
  • Support development of cell-based potency assays for early-stage and clinical programs
  • Troubleshoot assays and optimize methods to improve performance and reproducibility
  • Maintain accurate and organized laboratory records and ensure data integrity
  • Collaborate with cross-functional teams including R&D, Clinical Development, and Translational Sciences
  • Coordinate with external CROs for sample analysis and timelines as needed
  • Contribute to regulatory documentation by supporting bioanalytical sections of INDs and other filings
  • Stay current with relevant technologies and apply new methods where appropriate
  • Present findings in team meetings and contribute to scientific discussions
  • Ensure compliance with GLP/GCP standards and internal quality systems




Qualifications



  • Ph.D. in Biology, Pharmacology, Bioanalytical Chemistry, or related discipline with 0-7 years of industry experience.
  • Demonstrated expertise in development, qualification, and validation of bioanalytical, biomarker, and cell‑based potency assays to support preclinical and clinical studies.
  • Deep, hands‑on experience with techniques such as qPCR, digital PCR, ligand‑binding assays (e.g., ELISA, MSD), LC‑MS/MS, flow cytometry, and reporter gene assays.
  • Strong understanding of PK/PD concepts, translational science, and how bioanalytical data informs dose selection and clinical strategy.
  • Proven track record leading bioanalytical workstreams and driving cross‑functional alignment in a fast‑paced biotech environment.
  • Experience managing CROs and external partners, including assay transfer, validation oversight, and routine sample testing.
  • Familiarity with regulatory expectations and guidance for bioanalytical methods and data in submissions to agencies such as FDA and EMA.
  • Excellent communication, leadership, and organizational skills, with the ability to operate strategically while remaining hands‑on as needed.

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