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Senior Scientist, Quality Control – Cell Therapy

Location: Philadelphia, PA Department: Research & Development / Quality Control

About the Company:

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

Bria-IMT™, BriaCell’s lead candidate, was awarded Fast Track status by the FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). Bria-IMT™ is a targeted cell-based immunotherapy.

Bria-OTS™, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer and other cancers.

Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

About the Position:

BriaCell Therapeutics is seeking an experienced Senior Scientist, Quality Control to play a key hands-on role in QC activities supporting our pivotal Phase 3 cell-based immunotherapy program and broader clinical pipeline. This individual will independently lead and execute analytical testing, assay qualification/validation, troubleshooting, data analysis, and QC documentation supporting product characterization, release, stability, and late-stage development.

This is a hands-on individual contributor role for an experienced QC scientist who is equally comfortable providing technical leadership and working at the bench. The Senior Scientist will independently own key QC activities while personally executing assays, investigating issues, interpreting data, and preparing required documentation. BriaCell operates with a small, highly collaborative team. Success in this position requires the ability to move fluidly between technical ownership, cross-functional collaboration, and day-to-day laboratory execution.

Responsibilities:

Quality Control Testing & Analytical Execution

  • Lead and perform QC testing supporting in-process, characterization, release, and stability programs for clinical cell therapy products.
  • Independently execute analytical methods including flow cytometry, ELISA, cell-based functional/potency assays, and other relevant QC methods
  • Review analytical data for accuracy, completeness, compliance, and suitability for product disposition and development decisions.
  • Ensure testing is performed in accordance with approved methods, specifications, SOPs, and applicable quality requirements.

Assay Development, Qualification & Validation

  • Lead or independently execute development, optimization, qualification, validation, verification, and transfer of analytical methods used to characterize cell therapy products.
  • Establish scientifically justified assay acceptance criteria and support development of specifications and qualification/validation strategies.
  • Evaluate assay performance using appropriate statistical approaches, including precision, accuracy, linearity, robustness, variability, and reproducibility.
  • Monitor and trend assay performance and identify opportunities to improve method robustness, consistency, and lifecycle control.

Investigations, Troubleshooting & Quality Systems

  • Serve as a technical subject matter expert for complex assay troubleshooting and laboratory investigations.
  • Lead or support OOS, OOT, deviation, and laboratory investigations, including root-cause analysis and scientifically sound corrective actions.
  • Author, review, and maintain SOPs, analytical methods, qualification/validation protocols, technical reports, and investigation documentation.
  • Maintain complete, accurate, and inspection-ready laboratory records in accordance with data integrity and quality expectations.
  • Support CAPA, change control, and other quality-system activities as applicable.

Late-Stage Development & Regulatory Support

  • Support QC activities associated with BriaCell’s pivotal Phase 3 program and future commercialization-readiness milestones.
  • Contribute analytical and QC data to regulatory documentation, technical reports, and responses to regulatory requests.
  • Support inspection readiness and participate as a QC technical SME during audits or regulatory interactions, as needed.
  • Support analytical lifecycle activities related to cell banks, drug product, stability programs, and late-stage manufacturing.

Cross-Functional & External Collaboration

  • Represent QC on cross-functional teams spanning R&D, Manufacturing, CMC, Quality, Regulatory, and Clinical functions.
  • Partner with external testing laboratories and manufacturing organizations to support method transfer, technical troubleshooting, and review of externally generated QC data.
  • Communicate analytical risks, assay performance issues, and recommendations clearly to scientific and cross-functional stakeholders.
  • Provide technical guidance and mentorship to less-experienced scientists, where appropriate.

Qualifications:

  • PhD in Immunology, Cell Biology, Biochemistry, Molecular Biology, or a related scientific discipline.
  • 5+ years of relevant biotechnology or pharmaceutical industry experience; candidates with approximately 5–10 years of progressively responsible QC experience are particularly well aligned with this role.
  • Hands-on expertise with flow cytometry and experience with cell-based functional/potency assays and/or ELISA
  • Experience supporting GMP release and/or stability testing.
  • Experience authoring and executing SOPs, analytical methods, qualification/validation protocols, and technical reports.
  • Demonstrated ability to independently troubleshoot complex analytical assays and investigate performance issues.
  • Strong understanding of statistical approaches used to evaluate assay performance, including precision, accuracy, variability, linearity, robustness, and reproducibility.
  • Strong laboratory documentation practices, data integrity awareness, and attention to detail.

Preferred Qualifications

  • Experience supporting late-stage clinical, Phase 3, or commercialization-readiness programs
  • Cell therapy, cellular immunotherapy, immuno-oncology, or related biologics experience
  • Experience with potency assays and product characterization for cellular products
  • Experience with analytical method transfer to internal or external QC laboratories
  • Experience with OOS/OOT investigations, deviations, CAPAs, and change controls.
  • Familiarity with cGMP, FDA expectations for biologics/cellular therapies, ICH guidance, USP standards, method validation, stability, and data integrity requirements.
  • Experience supporting regulatory filings, audits, inspections, or health authority responses.
  • Experience overseeing or partnering with CROs, CMOs, or external testing laboratories.
  • To apply, Please kindly send your resumes to careers@briacell.com

    Equal Employment Opportunity Statement

    BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

    Third-Party Agency Statement

    BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.

    Scientist, Translational Immunology & Biomarkers

    Location: Philadelphia, PA / Onsite

    About the Company:

    BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

    Bria-IMT™, BriaCell’s lead candidate, was awarded Fast Track status by FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). MBC is breast cancer that has spread to other tissues. Bria-IMT™ is a targeted cell-based immunotherapy.

    Bria-OTS™, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer, and other cancers.

    To apply, Please kindly send your resumes to careers@briacell.com

    About the Position:

    The Scientist, Translational Immunology & Biomarkers will play a key role in designing and executing biomarker and immune-monitoring strategies across BriaCell’s clinical immunotherapy programs. Working at the intersection of Research and Clinical Development, this scientist will characterize treatment-induced immune responses, evaluate pharmacodynamic biomarkers, and identify translational correlates associated with clinical activity.

    This is a hands-on scientific role with responsibility for immunologic assay development and execution, clinical biomarker data analysis and interpretation, and scientific oversight of external laboratories and CROs. The Scientist will work closely with Research, Clinical Development, Clinical Operations, and Regulatory colleagues to translate biomarker findings into insights that inform clinical development of BriaCell’s cell-based immunotherapies

    Responsibilities:

    • Design and execute immunomonitoring and translational biomarker strategies across oncology clinical trials.
    • Develop, optimize, troubleshoot, and execute immune-monitoring assays using clinical samples, including multiparameter flow cytometry, ELISpot/FluoroSpot, intracellular cytokine staining, T-cell functional assays, multiplex cytokine profiling, and humoral immune-response assays
    • Coordinate and oversee clinical biomarker sample collection, processing, tracking, and analysis across PBMC, whole blood, serum/plasma, and tumor-tissue specimens.
    • Analyze and interpret complex immunologic and biomarker datasets to characterize treatment-induced immune responses, pharmacodynamic activity, and translational correlates of clinical outcomes.
    • Provide scientific oversight of CROs and specialty laboratories, including assay transfer/qualification, troubleshooting, study execution, and critical review of data and deliverables.
    • Collaborate with Clinical Development, Clinical Operations, Research, and Regulatory colleagues to integrate biomarker findings into clinical-program strategy.
    • Maintain rigorous experimental documentation and ensure high-quality, reproducible biomarker data.
    • Communicate findings through scientific presentations, reports, and cross-functional program discussions.

    Qualifications:

    Required:

    • PhD in Immunology, Cancer Biology, Molecular Biology, or a related field with 2–4+ years of relevant industry experience
    • Strong background in immunology and immune monitoring
    • Hands-on experience with flow cytometry, PBMC handling, ELISpot, and functional immune assays.
    • Experience designing and optimizing of spectral flow cytometry panel
    • Experience analyzing human translational or clinical biomarker data
    • Strong organizational and analytical skills
    • Comfortable working collaboratively in a team-oriented environment, with the ability to communicate effectively and contribute positively across functions.
    • Knowledge of FlowJo, GraphPad Prism, and basic biomarker data analysis tools .

    Preferred:

    • Experience in immuno-oncology or oncology clinical development
    • Familiarity with cancer vaccines, cell-based immunotherapies, or checkpoint inhibitor combinations
    • Experience with CRO oversight and clinical biomarker workflows

    To apply, Please kindly send your resumes to careers@briacell.com

    Equal Employment Opportunity Statement

    BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

    Third-Party Agency Statement

    BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.

    Clinical Research Associate Intern

    About the Company

    BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

    Bria-IMT™, BriaCell’s lead candidate, was awarded Fast Track status by FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). MBC is breast cancer that has spread to other tissues. Bria-IMT™ is a targeted cell-based immunotherapy.

    Bria-OTS™, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer, and other cancers.

    Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

    About the Position

    The Clinical Research Associate Intern supports the Clinical Development and Clinical Operations teams in the execution and oversight of clinical trials for an immuno-oncology biotechnology company. This internship provides exposure to clinical trial operations, study-site management, regulatory documentation, clinical data review, and cross-functional drug-development activities.

    Reporting to the Director, Clinical Trial Manager, the intern will assist with activities that support study quality, timely execution, Good Clinical Practice (GCP), and accurate clinical documentation. The role is intended for a student or recent graduate seeking practical experience in biotechnology, oncology, immunotherapy, or clinical research.

    Responsibilities

    • Support Clinical Research Associates and Clinical Operations team members with day-to-day clinical trial activities.
    • Assist with tracking study-site activities, enrollment, patient recruitment, study milestones, and outstanding action items.
    • Help prepare for site initiation, monitoring, and close-out activities.
    • Review and organize clinical study documentation, including protocols, informed consent forms, case report forms, monitoring reports, and study correspondence.
    • Assist with maintenance and quality review of Trial Master File documentation and other clinical study records.
    • Support tracking of protocol deviations, data queries, site findings, and follow-up actions.
    • Assist with review of clinical study data for completeness, consistency, and potential discrepancies under appropriate supervision.
    • Support preparation of investigator meetings, site meetings, study-team meetings, and clinical training materials.
    • Assist with communications and follow-up with clinical sites, investigators, CROs, vendors, and other external partners.
    • Help maintain study trackers, dashboards, contact lists, timelines, and other clinical operations tools.
    • Support preparation of clinical summaries, presentations, reports, and study updates.
    • Participate in cross-functional meetings with Clinical Development, Medical, Data Management, Biostatistics, Regulatory, Translational Research, and other functions.
    • Gain familiarity with clinical safety, efficacy, biomarker, and operational data relevant to immuno-oncology clinical trials.
    • Review scientific and clinical literature related to oncology, immunotherapy, tumor immunology, biomarkers, and competitive clinical programs, as assigned.
    • Assist with selected patient-recruitment and retention activities, including tracking enrollment trends and site recruitment challenges.
    • Support clinical teams in maintaining inspection-ready documentation and adherence to applicable company procedures.
    • Maintain confidentiality of patient, clinical, scientific, and company information.
    • Perform other clinical research and administrative activities as assigned.

    Learning Opportunities

    • Clinical trial design and execution
    • Clinical site monitoring and management
    • Good Clinical Practice
    • Oncology and immunotherapy drug development
    • Clinical data review
    • Patient recruitment and retention
    • Clinical safety and efficacy assessment
    • Biomarker and translational research interfaces
    • CRO and vendor management
    • Clinical documentation and Trial Master File practices
    • Cross-functional biotechnology development processes

    Qualifications

    Education

    Currently enrolled in, or recently graduated from, a bachelor's or graduate-level program in a relevant scientific or health-related discipline. Relevant fields may include biology, immunology, molecular biology, cell biology, biochemistry, biotechnology, pharmacology, biomedical sciences, public health, nursing, clinical research, or a related field.

    Preferred Qualifications

    • Interest in oncology, immunology, immunotherapy, cell therapy, or clinical drug development.
    • Coursework or previous research experience in biology, immunology, oncology, clinical research, or related discipline.
    • Familiarity with clinical research concepts and GCP is preferred but not required.
    • Experience working in a research laboratory, academic research environment, healthcare setting, or biotechnology company is helpful.
    • Strong proficiency with Microsoft Word, Excel, and PowerPoint.

    Knowledge, Skills, and Abilities

    • Strong organizational skills and attention to detail.
    • Ability to accurately maintain records, trackers, and documentation.
    • Strong written and verbal communication skills.
    • Ability to interpret basic scientific and clinical information.
    • Interest in learning clinical research regulations, processes, and terminology.
    • Ability to manage multiple assignments and deadlines.
    • Strong analytical and problem-solving skills.
    • Ability to work effectively with cross-functional teams.
    • Professional judgment and discretion when handling confidential information.
    • Willingness to ask questions, seek guidance, and learn in a fast-paced biotechnology environment.
    • Commitment to patient safety, data integrity, scientific rigor, and ethical clinical research.
    • Limited travel to clinical sites, investigator meetings, company meetings, or scientific conferences may be available depending on business needs and the duration of the internship.

    To apply, Please kindly send your resumes to careers@briacell.com

    Equal Employment Opportunity Statement

    BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

    Third-Party Agency Statement

    BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.

    Oncology Clinical Research Associate, Data Mgmt., Analytics & Statistical Support

    Location: Philadelphia, PA / Onsite – Travel Required

    About the Company

    BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

    Bria-IMT™, BriaCell’s lead candidate, was awarded Fast Track status by FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). MBC is breast cancer that has spread to other tissues. Bria-IMT™ is a targeted cell-based immunotherapy.

    Bria-OTS™, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer, and other cancers.

    Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

    About the Position

    We are seeking a flexible and experienced Oncology Clinical Research Coordinator (CRC) or newly transitioned Clinical Research Associate (CRA) to join our Clinical Operations team. This position will be based at BriaCell’s Philadelphia labs/offices and requires the individual to work onsite when not traveling for monitoring, site support, or other study-related activities. The role supports oncology clinical trials and is open to candidates with experience in CROs or academic institutions, even if they lack direct sponsor experience.

    In addition to clinical operations expertise, the ideal candidate will bring a strong background in data management, data analytics, and statistical interpretation, with demonstrated experience analyzing clinical trial data to support study execution, monitoring, and decision‐making.

    Strong communication skills are essential, including the ability to respond promptly to site questions and provide clear, real-time guidance on logistical and operational matters. Team members are also expected to understand and follow each site’s operational policies and requirements.

    Responsibilities

    Site Monitoring

    • Conduct regular onsite and remote monitoring visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
    • Execute monitoring plans tailored to each study.
    • Review case report forms (CRFs), source documentation, and data entries for accuracy, completeness, and consistency.
    • Identify data discrepancies and collaborate with clinical operations team members to ensure timely query resolution.
    • Resolve site-related issues and manage investigational product logistics
    • Maintain strong relationships with site staff and provide real-time support on eligibility, protocol logistics, and operational questions.
    • Deliver high-quality presentations during SQVs/SIVs.

    Data Management, Analytics & Statistical Support

    • Review and interpret clinical trial data to identify trends, risks, and data quality issues
    • Support data cleaning, query management, and reconciliation activities in collaboration with clinical operations team.
    • Analyze enrollment trends, protocol deviations, and site performance metrics
    • Apply basic statistical concepts to interpret trial data and support operational decision-making
    • Contribute to development of data tracking tools, dashboards, and performance reports
    • Ensure accuracy and completeness of data within EDC and other clinical systems (CTMS, IRT)
    • Participate in cross-functional data review meetings and support data-driven study execution

    Recruitment and Retention Strategies

    • Develop and implement tailored patient recruitment and retention plans using approved vendors
    • Analyze recruitment data and site performance metrics to drive strategic improvements
    • Collaborate with site staff to identify and overcome recruitment barriers
    • Track and report recruitment KPIs and provide actionable insights to the project team
    • Prioritize recruitment support and re-training for underperforming sites
    • Conduct in‐service training and apply engagement strategies to improve enrollment

    Communication and Collaboration

    • Serve as the primary point of contact for study sites
    • Collaborate cross-functionally with Clinical Operations, Regulatory and Discovery teams
    • Prepare and present study progress reports, including data trends and analytics insights, to stakeholders

    Training and Development

    • Train and mentor site staff on protocols, GCP, data entry expectations, and system use (EDC/CTMS)
    • Stay current with industry trends, data management practices, and evolving regulatory expectations

    Qualifications

    • Bachelor’s degree in life sciences, nursing, or related field required
    • Clinical degree (MD, RN, PharmD, or equivalent) preferred.
    • Experience in data management, clinical data review, and/or data analytics required
    • Background in statistics, epidemiology, or data analysis strongly preferred
    • Minimum 2–3 years of oncology clinical research experience (CRC or CRA)
    • Experience in CROs or academic institutions acceptable in lieu of direct sponsor experience
    • Strong understanding of GCP, ICH guidelines, and regulatory requirements
    • Demonstrated ability to interpret clinical trial data and apply analytical thinking
    • Proficiency with EDC systems, CTMS, and data tracking/reporting tools
    • Excellent communication, presentation, and problem-solving skills
    • Ability to respond promptly to site inquiries and logistical needs
    • Ability to travel regularly based on monitoring and recruitment requirements

    To apply, Please kindly send your resumes to careers@briacell.com

    Equal Employment Opportunity Statement

    BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

    Third-Party Agency Statement

    BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.