Careers

Location: Philadelphia, PA Department: Research & Development

Position Summary
BriaCell Therapeutics is seeking a Scientist or Senior Scientist – Quality Control to support analytical and quality control activities within the R&D organization. This role will contribute to the development, qualification, and execution of analytical assays used to characterize cell-based immunotherapies and support research, development, and manufacturing programs.

The successful candidate will work closely with scientists across the organization to ensure assay rigor, data integrity, and adherence to quality standards, while supporting analytical methods used for product characterization and release testing.

Key Responsibilities

• Perform and support QC testing including flow cytometry, ELISA, cell-based assays, and other analytical methods.
• Assist in the development, optimization, and qualification of analytical assays used to characterize cell therapy products.
• Ensure QC assays are executed according to established protocols and quality standards.

• Support assay qualification activities including evaluation of precision, accuracy, linearity, and robustness.
• Apply appropriate statistical approaches to assess assay performance and reproducibility.
• Participate in defining assay acceptance criteria and qualification plans.
• Maintain complete and accurate experimental documentation and data records.

• Contribute to the preparation and maintenance of standard operating procedures (SOPs), protocols, and technical reports.
• Ensure proper documentation of QC testing and experimental records in accordance with internal quality standards.
• Assist in maintaining an organized and audit-ready laboratory environment.

• Work collaboratively with research scientists, manufacturing partners, and external testing laboratories.
• Support analytical characterization activities related to cell banks, drug product, and research programs.
• Assist in compiling analytical data for internal reports and regulatory documentation.

Qualifications

• PhD in Immunology, Cell Biology, Biochemistry, or related field, with relevant experience

• Experience with analytical assays commonly used in immunology or cell therapy, such as flow cytometry, ELISA, and cell-based functional assays.
• Experience supporting assay development or qualification is preferred.
• Experience working in a biotechnology or pharmaceutical research environment.

• Expertise in statistical approaches used in assay development and qualification in a regulatory environment, including assessment of assay precision, variability, linearity, and reproducibility.
• Experience with flow cytometry and immunological assays is highly desirable.
• Strong laboratory documentation practices and attention to data integrity.

• Strong attention to detail and commitment to high-quality experimental work.
• Ability to work effectively in a collaborative, cross-functional research environment.
• Strong organizational and communication skills.

BriaCell Therapeutics is a biotechnology company developing innovative cellular immunotherapies designed to activate the immune system to target cancer. Our research focuses on developing cell-based vaccine platforms capable of generating durable anti-tumor immune responses.

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

Hybrid/Remote-Travel Required

Clinical degree or foreign equivalent is required

We are seeking a flexible and experienced (Clinical degree or foreign equivalent is required) Oncology Clinical Research Coordinator (CRC) or a newly transitioned Clinical Research Associate (CRA) to join our dynamic Clinical Operations team. This hybrid role supports oncology clinical trials and is open to candidates with experience in CROs or academic institutions, even if they lack direct sponsor experience.

**We also welcome international clinical research professionals who are authorized to work in the United States for any employer and bring prior hands-on experience with U.S.-based clinical research trials**

Remote work flexibility is available, with the expectation that team members adhere to each site's operational policies and requirements. Strong communication skills are essential, with an emphasis on real-time responsiveness to logistical and operational questions from sites.

• Conduct regular on-site and remote monitoring visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Complete monitoring plans tailored to each study.
• Review case report forms (CRFs) and source documents for accuracy and completeness.
• Resolve site-related issues and manage investigational product logistics.
• Maintain positive relationships with site staff and provide real-time support on patient eligibility, protocol logistics, and operational questions.
• Deliver high-quality presentations during SQVs/SIVs.

• Develop and implement tailored patient recruitment and retention plans using approved vendors.
• Collaborate with site staff to identify and overcome recruitment barriers.
• Track and report recruitment and retention metrics, providing regular updates to the project team.
• Prioritize recruitment support and re-training efforts for low-performing sites or those facing enrollment challenges.
• Conduct additional in-service training and apply engagement strategies to boost recruitment.
• Engage with site staff to ensure a positive study experience and address concerns.

• Serve as the primary point of contact for study sites, offering guidance and support.
• Collaborate with cross-functional teams including project managers, data managers, and regulatory affairs.
• Prepare and present study progress reports to internal and external stakeholders.

• Train and mentor site staff on study protocols, GCP, and regulatory requirements.
• Stay current with industry trends and best practices in clinical research and site management.

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degrees, including international clinical degrees, may be considered.
• Minimum 2-3 years of experience in oncology clinical research (CRC or CRA).
• Experience in CROs or academic institutions acceptable in lieu of direct sponsor experience.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong analytical and problem-solving skills.
• Excellent communication and presentation skills, especially for site-facing interactions.
• Ability to respond promptly to site inquiries and logistical needs.
• Willingness to travel weekly -based on monitoring/recruitment requirements.

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

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.

Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

About the Position:

We are seeking a motivated Scientist, Translational Biomarkers & Immunomonitoring to support biomarker strategy and immune monitoring across our clinical immunotherapy programs.

This role will focus on characterization of treatment-induced immune responses, pharmacodynamic biomarkers, and translational correlates of clinical activity. The successful candidate will contribute to biomarker assay execution, data analysis, CRO oversight, and cross-functional translational efforts supporting clinical development.

Responsibilities:

• Support immunomonitoring strategies across oncology clinical trials
• Coordinate biomarker sample collection, processing, tracking, and vendor execution for PBMCs, blood, serum/plasma, and tumor tissue
• Execute and oversee biomarker assays, including:
  • multiparameter flow cytometry
  • ELISpot / FluoroSpot
  • intracellular cytokine staining
  • T-cell functional assays
  • multiplex cytokine profiling
  • humoral immune response assays
  • tumor immune profiling (preferred)
• Analyze immunologic and biomarker datasets to assess treatment-related immune responses and pharmacodynamic activity
• Support external CRO/vendor management, assay troubleshooting, and data review
• Collaborate with Clinical Development, Clinical Operations, Research, Regulatory, etc.
• Prepare presentations, reports, and scientific summaries for internal review

Qualifications:

Required:

• PhD in Immunology, Cancer Biology, Molecular Biology, or related field
  OR
  
• MS with 3–6 years of relevant biotech experience
• Strong background in immunology and immune monitoring
• Hands-on experience with flow cytometry, PBMC handling, ELISpot, and functional immune assays
• 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.

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
• Knowledge of FlowJo, GraphPad Prism, and basic biomarker data analysis tools

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.

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 Senior Director, Quality Assurance will provide senior leadership across core quality systems, GxP compliance activities, and inspection readiness programs. This role is responsible for ensuring that quality systems and practices are scalable, risk-based, inspection-ready, and aligned with regulatory expectations and company priorities.

Reporting directly to the Vice President, Quality Assurance, the Senior Director will oversee broad quality functions, lead major cross-functional quality initiatives, guide quality strategy, and serve as a senior quality leader in business-critical decision-making. This position requires strong regulatory judgment, operational quality expertise, leadership presence, and the ability to influence effectively across Manufacturing, Clinical, Regulatory, R&D, vendors, CDMOs, and Executive Leadership.

Key Responsibilities

• Provide senior leadership across quality operations, compliance systems, and GxP programs.
• Lead broad quality functions across multiple areas, programs, vendors, or external partners.
• Develop and execute quality strategies that support clinical development, manufacturing readiness, regulatory milestones, and organizational growth.
• Oversee quality governance, risk management, deviations, CAPAs, change control, audits, vendor oversight, documentation practices, and management review activities.
• Lead inspection readiness strategy and support regulatory inspections, partner audits, internal audits, and due diligence activities.
• Ensure quality systems are compliant, scalable, inspection-ready, and appropriate for the company’s stage of development.
• Partner with Manufacturing, Clinical, Regulatory, R&D, CDMOs, vendors, and Executive Leadership to identify and manage quality and compliance risks.
• Serve as a senior quality representative in cross-functional decision-making and strategic business discussions.
• Provide leadership during significant quality events, escalations, investigations, or remediation activities.
• Review and approve high-risk, business-critical, or regulatory-impacting quality documentation.
• Establish, monitor, and report quality metrics, trends, risks, and improvement opportunities to senior leadership.
• Drive continuous improvement, standardization, and sustainable implementation across quality systems.
• Lead, mentor, and develop quality managers and staff, strengthening team capability, accountability, and readiness for future growth.
• Promote a culture of compliance, proactive risk management, operational discipline, and continuous improvement.

Qualifications

• Bachelor’s degree in life sciences, biology, chemistry, pharmaceutical sciences, engineering, or a related scientific discipline required.
• Minimum of 12 years of progressive experience in Quality Assurance, Quality Systems, Compliance, or a related quality function within a regulated biotech, pharmaceutical, cell therapy, biologics, or clinical-stage life sciences environment.
• Minimum of 7 years of experience leading quality operations, quality systems, inspection readiness, deviations, CAPAs, change control, audits, vendor oversight, documentation practices, or quality governance.
• Minimum of 5 years of people leadership experience, including managing, coaching, and developing managers and staff.
• Strong working knowledge of applicable GxP requirements, including GMP, GCP, GLP, or related regulatory expectations as applicable to the business.
• Demonstrated experience leading inspection readiness activities and supporting regulatory inspections, partner audits, internal audits, or due diligence activities.
• Strong understanding of Quality Management Systems and the ability to translate regulatory expectations into practical, scalable business processes.
• Experience working cross-functionally with Manufacturing, Clinical, Regulatory, R&D, external vendors, CDMOs, and senior leadership.
• Demonstrated ability to lead through complexity, influence without direct authority, and make sound risk-based decisions.

Key Competencies

• Senior-level regulatory and operational quality judgment.
• Strong risk-based decision-making and issue-escalation discipline.
• Ability to lead broad functions, major systems, and enterprise-level quality initiatives.
• Strong inspection-readiness and quality governance mindset.
• Effective executive communication and ability to influence senior leaders.
• Ability to balance compliance, business priorities, timelines, quality risk, and organizational capacity.
• Strong leadership presence and credibility with internal stakeholders, vendors, partners, and auditors.
• Talent-development mindset with the ability to build leadership capability within the quality function.
• Continuous improvement orientation and ability to strengthen systems in a growing organization.
• Ability to build structure, accountability, and consistency across quality processes.

Preferred Experience

• Experience in immuno-oncology, biologics, cell therapy, oncology clinical development, or early- to mid-stage biotechnology.
• Experience with cell lines.
• Experience working with CDMOs.
• Experience supporting Phase 1-3 drug development.
• Clinical trial knowledge, including quality considerations across clinical development programs.
• Experience supporting external manufacturing, vendor qualification, supplier quality, or regulatory submissions.
• Experience building or improving processes in a growing organization.
• Experience preparing teams for regulatory inspections, partner audits, or due diligence activities.

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.

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.