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Cell Based Potency Assay Jobs in Raleigh, NC (NOW HIRING)

BioAgilytix

Analyst III - Cell-based

Durham, NC · On-site

Troubleshoot assays * Compile/process data (make power export) * Prepare summary tables * Peer ... Hands-on experience performing cell-based assays. * Knowledge of mammalian cell culture techniques ...

AskBio

Associate Scientist, AS&T

Durham, NC

... cell-based potency assays, NGS, HPLC, and AUC, driving method evolution, troubleshooting complex technical challenges, and enabling program objectives. * Guide the design and execution of ...

AskBio

Associate Scientist, AS&T

Durham, NC · On-site

... cell-based potency assays, NGS, HPLC, and AUC, driving method evolution, troubleshooting complex technical challenges, and enabling program objectives. * Guide the design and execution of ...

KBI Biopharma, Inc.

KBI: US - Scientist I

Durham, NC · On-site

$86K - $115K/yr

Perform analyses and evaluate data from bioassays, including cell-based assays and ELISAs. Responsibilities: * Regularly exercises technical discretion in the execution and interpretation of ...

KBI Biopharma, Inc.

KBI: US - Scientist I

Durham, NC

$86K - $115K/yr

Perform analyses and evaluate data from bioassays, including cell-based assays and ELISAs. Responsibilities: * Regularly exercises technical discretion in the execution and interpretation of ...

Duke University

Postdoctoral Associate

Durham, NC · On-site

Flow cytrometry / cell-based assays / B-T cell interaction Choose Duke. Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age ...

Duke University

Postdoctoral Associate

Durham, NC

Flow cytrometry / cell-based assays / B-T cell interaction Choose Duke. Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age ...

Advanced Recruiting Partners

Senior Scientist

Durham, NC · On-site

$82K - $113K/yr

This individual will play a key role in executing and optimizing a variety of molecular and cellular assays focused on DNA, RNA, proteins, and cell-based systems. The ideal candidate brings strong ...

UNC-Chapel Hill

Open Rank

Chapel Hill, NC · On-site

... and/or cell-based functional receptor pharmacology assays. 4. Strong peer-reviewed publication record in computational, structural, and/or molecular neuroscience. Preferred Qualifications ...

AskBio

Associate Scientist, Immunology

Durham, NC · On-site

Independently design and execute complex assays related to neutralizing and total antibody development, utilizing strong scientific expertise and knowledge of adeno viral vector and cell-based ...

AskBio

Associate Scientist, Immunology

Durham, NC

Independently design and execute complex assays related to neutralizing and total antibody development, utilizing strong scientific expertise and knowledge of adeno viral vector and cell-based ...

DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred. * Proficiency in ...

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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 are popular job titles related to Cell Based Potency Assay jobs in Raleigh, NC?

For Cell Based Potency Assay jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Cell Based Potency Assay jobs in Raleigh, NC look for?

The top searched job categories for Cell Based Potency Assay jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Cell Based Potency Assay jobs?

Cities near Raleigh, NC with the most Cell Based Potency Assay job openings:

Cell Based Potency Assay jobs near you

Associate Scientist, AS&T

Asklepios BioPharmaceutical, Inc.

Durham, NC • On-site

Full-time

Posted 19 days ago

Job description

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need.
  • Provide an environment for employees to reach their fullest potential.

Our values:
  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.

Analytical support
  • Lead the development and implementation of phase-appropriate analytical control strategies for gene therapy products, integrating scientific expertise, regulatory expectations, and product knowledge to ensure robust product characterization and lifecycle support.
  • Apply advanced scientific knowledge and broad analytical expertise to direct lifecycle management of complex bioanalytical methods, including but not limited to PCR/ddPCR, ELISA, cell-based potency assays, NGS, HPLC, and AUC, driving method evolution, troubleshooting complex technical challenges, and enabling program objectives.
  • Guide the design and execution of scientifically sound method qualification, validation, transfer, and comparability strategies for rAAV programs, leveraging comprehensive understanding of regulatory requirements, assay performance, and product development considerations.
  • Integrate and interpret analytical data across multiple programs and functional disciplines to identify trends, assess method variability and provide strategic recommendations that support product quality, process understanding, and decision-making.
  • Apply statistical methodologies and scientific judgment to evaluate assay performance, capability, robustness, and lifecycle suitability, developing innovative approaches to address complex analytical challenges and improve data-driven decision-making.
  • Drive continuous improvement and innovation in analytical sciences through the advancement of emerging technologies, digitalization, automation, and novel scientific approaches, guiding the development of new procedures, enhancing operational efficiency, and strengthening analytical capabilities across the organization

Tech transfer and external partner management
  • Lead analytical method transfers across CDMOs, CROs, and internal QC laboratories, applying broad scientific expertise and strategic oversight to ensure successful implementation, knowledge transfer, and sustained method performance throughout the product lifecycle
  • Author, review, and approve transfer protocols, validation strategies, technical reports, and scientific justifications, ensuring alignment with regulatory expectations, quality standards, and program objectives while advancing best practices in analytical sciences
  • Serve as the Analytical Sciences & Technology (AS&T) subject matter expert for external partners, leveraging technical knowledge and cross-functional understanding to establish scientific alignment, resolve complex analytical issues, and drive effective outcomes across organizational boundaries.
  • Lead troubleshooting and resolution of cross-site analytical challenges by integrating scientific principles, data-driven approaches, and multidisciplinary expertise to ensure method consistency, robustness, comparability, and compliance across global laboratory networks.

Quality support
  • Provide scientific oversight for complex analytical investigations, including OOS, OOT, and deviation events, applying technical expertise, data-driven methodologies, and multidisciplinary knowledge to aid in the identification of root causes, assess impact, and develop effective resolution strategies.
  • Partner with Quality, Manufacturing, Regulatory, and other functional areas to develop, and implement, scientifically sound CAPAs, ensuring sustainable improvements, operational excellence, compliance, and alignment with company objectives.
  • Drive inspection readiness by providing scientific leadership in the evaluation, documentation, and resolution of analytical quality events, ensuring robust investigation practices, regulatory compliance, and continuous improvement across the analytical lifecycle.

Regulatory
  • Author and review analytical sections of global regulatory submissions (IND, BLA, MAA), leveraging expertise in analytical control strategies and regulatory requirements to support successful product development and registration
  • Participate in the development and continuous evolution of analytical control strategies, integrating multidisciplinary scientific insights, product knowledge, and emerging regulatory guidance to ensure robust product quality, control, and lifecycle management.
  • Support regulatory interactions, inspections, and responses as an analytical SM

Minimum Requirements
  • Bachelor's degree in biology, microbiology, molecular biology, biotechnology or related field with 8+ years of relevant work experience, or a Master's degree with 4+ years of relevant work experience
  • Demonstrated experience working in matrix organizations and independent management of cross-functional initiatives
  • Ability to influence without direct authority across teams and functions
  • Hands-on experience supporting GMP environments
  • Experience with method validation, transfer, and lifecycle management
  • Knowledge of analytical methods supporting biologics manufacturing
  • Understanding ICH, FDA, and EMA requirements for gene therapy products.
  • Excellent written and verbal communication skills
  • High attention to detail and data integrity mindset
  • Strong problem-solving and investigative skills

Preferred Education, Experience and Skills
  • Industry experience with strong focus on gene therapies analytical methodologies
  • Experience with stability studies and impurity profiling
  • Project management and prioritization skills
  • Experience supporting regulatory filings and agency interactions
  • Knowledge of Quality by Design (QbD) and risk-based approaches

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

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