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Potency Assay Analytical Jobs (NOW HIRING)

$67K - $92K/yr

Perform tissue culture-based potency assays on live vaccine products, process intermediates, and ... Provide analytical assay/technical support for new and in-line vaccine programs * Routine sample ...

Performs analytical testing including relative potency assay, protein expression assay, flow cytometry, cell count, cell viability, qPCR/dPCR, etc. * Support tracking and trending systems, and ...

Quality Control Analyst III/IV

Seattle, WA · On-site

$27.25 - $36.75/hr

... potency assays used for in-process and product release testing. * Own development, optimization, and transfer of analytical methods from internal/external partners in alignment with ICH / FDA ...

Showing results 41-60

Potency Assay Analytical information

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$29.5K

$100.7K

$193.5K

How much do potency assay analytical jobs pay per year?

As of Sep 13, 2026, the average yearly pay for potency assay analytical in the United States is $100,673.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,500.00 and $125,000.00 per year, depending on experience, location, and employer.

What is a potency assay analytical specialist?

A Potency Assay Analytical specialist is a scientist or technician who designs, conducts, and validates assays that measure the biological or chemical activity (potency) of pharmaceutical products, especially biologics and vaccines. Their work ensures that drugs meet required potency specifications for efficacy and regulatory approval. They use a variety of analytical techniques, such as cell-based assays, ELISA, or chromatographic methods, to assess product strength and consistency. This role is crucial in quality control and product development within pharmaceutical and biotechnology companies.

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

To excel as a Potency Assay Analytical Scientist, you need a solid background in biochemistry, molecular biology, or a related field, often with a bachelor’s or master’s degree. Familiarity with analytical techniques such as ELISA, PCR, cell-based assays, and experience using laboratory information management systems (LIMS) are typical requirements. Attention to detail, problem-solving, and effective communication are critical soft skills for interpreting data and collaborating with cross-functional teams. These competencies ensure accurate assay development, regulatory compliance, and the reliable measurement of drug potency in pharmaceutical environments.

What are some common challenges faced by professionals in potency assay analytical roles, and how are they typically addressed?

Professionals in Potency Assay Analytical roles often encounter challenges such as establishing robust, reproducible assay methods and ensuring regulatory compliance. Variability in biological samples and complex data analysis can also pose difficulties. These challenges are typically managed by collaborating closely with cross-functional teams, implementing rigorous method validation protocols, and regularly calibrating instruments. Ongoing training and clear documentation help maintain consistency and regulatory standards, ensuring data integrity throughout the assay process.

What is the difference between Potency Assay Analytical vs Microbiologist?

AspectPotency Assay AnalyticalMicrobiologist
Required CredentialsLaboratory certifications, scientific degreesBiology, microbiology degrees, lab certifications
Work EnvironmentPharmaceutical or biotech labs, quality controlResearch labs, healthcare, environmental testing
Industry UsageDrug development, quality assuranceMedical, environmental, food safety

Potency Assay Analytical professionals focus on measuring the biological activity of drugs to ensure efficacy, often working in pharmaceutical labs. Microbiologists study microorganisms, including bacteria and fungi, in various settings. While both roles require laboratory skills and scientific credentials, their focus areas differ significantly, with Potency Assay Analytical specialists concentrating on drug potency and microbiologists on microbial analysis.

What other helpful pages are available for Potency Assay Analytical?

Other pages related to Potency Assay Analytical:

Infographic showing various Potency Assay Analytical job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 93% Full Time, 4% Part Time, and 2% Contract. Highlights an 82% Physical, 5% Hybrid, and 13% Remote job distribution, with an average salary of $100,673 per year, or $48.4 per hour.

Senior Scientist, Analytical Development

Boston, MA

Crispr Therapeutics
Biotechnology Research and Development • 201 - 500 employees

$140K - $155K/yr

Full-time

Re-posted 23 days ago


Key responsibilities

  • Lead the development, optimization, and qualification of cell-based assays for Drug Products and Drug Substances.

  • Oversee cell-based assay technology transfer and qualification, including leading the team in qualifying and maintaining cell lines.

  • Provide technical and operational oversight to contract labs supporting cell-based potency tests.


Job description

Job Description:

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY(exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.CRISPR Therapeuticsis advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact,CRISPR Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco,California.

Job Summary

Reporting to the Director of Analytical Development, theSenior Scientistwillberesponsiblefordevelopment, implementation, and qualification of cell-basedassays(potency, immunogenicity, etc.).The candidate will leadcell-basedanalytical technology transfers from Analytical Development to collaborators within and outside CRISPR Therapeutics.They will also authorsections of regulatory briefing packages or submissions related to technicalrole.

Responsibilities

  • Lead a team responsible for the development, optimization, and technology transfer and qualification of cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio, including potency assays for ex-vivo and in-vivo programs. Lead the team in qualifying andmaintainingcell lines for various potency assays.

  • Expertise in flow cytometry-based assays required to support various cell-based testing. Lead team responsible for trending potency data andestablishingspecifications for lot release and stability studies.

  • Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products across the portfolio.

  • Maintain awareness of applicable regulatory guidelines inareaof expertise, including but not limited to guidelines from ICH, USP, EP, and JP.

Minimum Qualifications

  • Ph.D. in Biology, Chemistry, ChemicalEngineeringor related discipline with4 -8+years ofpost-PhDrelevant industry experience, or non-PhD with 12-15 years of relevant experience.

  • Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, sanger sequencing, and amplicon next generation sequencing platforms.

  • Proficient in statisticalanalysessoftware, including JMP,GraphPAD,Qubas,Softmax,FlowJo,MACSQuantify.

  • Proficient in parallel line analysis for interpretation of potency data.

  • Expertiseapplied to both ex-vivo and in-vivo cell and gene therapy platforms.

  • Experience in leading assay lifecycle management for Cell and Gene Therapy products is strongly desired.

Preferred Qualifications

  • Ability to mentor a team of scientistsinto increasingresponsibility.

  • Experience with authoring regulatory submission documents.

  • Experience with leading analytical method transfer and supporting process technology transfer.

  • Awareness of regulatory guidelines in FDA and EMA guidance documents, CFR, ICH, USP, and Ph. Eur.

  • Proficient in risk assessments to support comparability assessments, process and method changes, andestablishdrug product critical quality attributes.

  • Ability to work in cross functional teams supporting product development and tech transfers.

Competencies

  • Collaborative - Openness, One Team

  • Undaunted - Fearless, Can-do attitude

  • Results Orientation - Delivering progress toward our mission.Senseof urgency in solving problems.

  • Entrepreneurial Spirit - Proactive. Ownership mindset.

Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.

Senior Scientist, Analytical Development: Base pay range of $140,000 to $155,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy