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Cell Based Potency Assay Jobs (NOW HIRING)

UCB

Scientist II - Molecular Analytics & NGS

Boston, MA · Hybrid

$99K - $130K/yr

Utilizing strong biology foundations to help guide or run cell-based potency assays to evaluate biological function and activity * Support gene therapy platform development through the application of ...

US Tech Solutions

R&D Scientist

Lake Forest, IL · On-site

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 ...

UCB

Scientist II - Molecular Analytics & NGS

Boston, MA · On-site

$99K - $130K/yr

Utilizing strong biology foundations to help guide or run cell-based potency assays to evaluate biological function and activity * Support gene therapy platform development through the application of ...

Alcami-5

Scientist III - Bioassay

Wilmington, NC · On-site

The Scientist III, 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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All JobsCell Based Potency Assay Jobs

Cell Based Potency Assay information

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 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 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 September 2026, with employment types broken down into 1% As Needed, 75% Full Time, 17% Part Time, and 7% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution.

Vice President, Pharmaceutical Sciences

Cambridge, MA

Beam Therapeutics
Biotechnology Research and Development • 501 - 1,000 employees
Learn more about Beam Therapeuticsexternal

Full-time

Re-posted 3 days ago

Key responsibilities

  • Support the development and implementation of potency assays and analytical methods throughout the drug product lifecycle.

  • Lead, mentor, and develop the team responsible for assay development and support cross-functional collaboration for drug product development.

  • Prepare and review documentation for regulatory submissions and act as a subject matter expert during regulatory interactions.

Job description

Position Overview:

Beam is seeking a highly talented and motivated VP of Pharmaceutical Sciences, to support our advancing portfolio of in-vivo and ex-vivo programs. Serving as a subject matter expert, this leader will be accountable for supporting all our cell-based potency assays. Their role will also drive our drug product development of our targeting moieties for our LNP platform and other macromolecules. They will support the lifecycle of the targeted drug product from IND submission through BLA approval. The candidate will define the strategic direction for our potency assays and key analytical methods, partnering closely with key stakeholders across the Pharmaceutical Sciences team. This is a high-impact leadership role requiring a data-driven, collaborative, results-oriented professional to ensure rapid progression of our key drug products through clinical development into commercial. This person will be responsible for comprehensive communication across all levels of the business, status reporting, risk management, escalation and resolution of issues.

Primary Responsibilities:

  • Provides strategic, technical, and tactical leadership for all potency assays.
  • Leads, mentors and develops the team responsible for the development of potency assays.
  • Accountable for in vitro assay strategy to enable an IND through a BLA.
  • Develop and implement strategic direction for analytical assays partnering with Analytical Development and Quality Control.
  • Develop and implement strategic direction for drug product development for key binders and ligands including resolving manufacturing challenges.
  • Work closely with CMC and cross-functional sub teams under the direction of the Program team(s).
  • Develop and implement comprehensive product lifecycle strategies around assay development, manufacturing, and quality control in conjunction with Quality Assurance, Quality Control, Manufacturing, Process, and Analytical Development.
  • Support lifecycle changes for potency assays.
  • Work directly with regulatory and key stakeholders on the development and implementation of platform processes and analytics across the product lifecycle for in-vivo programs.
  • Lead the preparation of source documentation and technical review of CMC sections for global regulatory submissions specifically focusing on Module 3.
  • Act as the subject matter expert during regulatory meetings and support information requests from regulatory agencies.
  • Actively identify risks across drug product areas during the product lifecycle. Oversee data-driven risk assessments and drive implementation of risk mitigations.
  • Partner with Quality Assurance to ensure our potency assays comply with current Good Manufacturing Practices (cGMP), ICH guidelines, and phase-appropriate compliance standards.

Qualifications:

  • MS, Ph.D., in Pharmaceutical Sciences, Biology, Biochemistry Chemistry, Chemical Engineering, Biomedical Engineering or equivalent technical field.
  • 15+ years of experience in CMC development, including leadership experience.
  • Strong experience and/or subject matter expertise in assay development, nucleic acid and/or Lipid Nanoparticle (LNP) manufacturing and analytics.
  • Demonstrated experience advancing programs from preclinical through IND acceptance and preferably through Biological License Application (BLA) submission.
  • Experience with cell based and analytical techniques such as HPLC, NGS, PCR, ELISA, MS, RNA quantitation, cell-based assays.
  • External CDMO alliance management experience and oversight preferred.
  • Strong background in participating in regulatory submissions and interactions.
  • Strong knowledge of critical quality attributes and quality by design principles for nucleic acids and/or lipid nanoparticles.
  • Strong cGMP manufacturing knowledge.
  • High attention to detail with strong risk identification, management, and problem-solving skills.
  • Able to effectively communicate upward (leadership) and outward (cross-functional teams) with strong presentation skills.

Apply