QC Laboratory Manager - Cell Therapy
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 QC Laboratory Manager oversees day-to-day Quality Control laboratory operations while personally performing GMP analytical testing supporting the manufacture and release of BriaCell Therapeutics' investigational cell-based immunotherapy products. This working manager combines extensive scientific and technical experience with responsibility for laboratory personnel, resources, compliance, and timely test execution.
Reporting to the Senior Director, Quality Assurance, the position independently conducts and troubleshoots release assays; leads analytical method transfer from development or external laboratories into routine QC testing; and guides method qualification, verification, and validation appropriate to intended use. The manager partners with Manufacturing, Quality Assurance, Research and Development, and external testing providers to deliver reliable, documented test results and build scalable laboratory capabilities for late-stage clinical development and potential commercialization.
Responsibilities
Hands-on GMP Release Testing
- Personally perform and oversee routine and nonroutine in-process, product release, and stability testing, as applicable, using approved analytical methods and specifications
- Execute relevant assays for identity, purity, potency, viability, and other established quality attributes; techniques may include multiparameter flow cytometry, ELISA, cell-based functional/potency assays, and cell counting and viability methods.
- Prepare and handle samples, standards, controls, and reagents; assess assay suitability and test results against predefined criteria.
- Troubleshoot assay performance, atypical results, sample issues, and instrument problems; escalate potential product quality concerns promptly.
- Coordinate testing with manufacturing schedules to support timely clinical product release while maintaining data integrity and scientific rigor.
Analytical Method Transfer and Lifecycle
- Lead transfer of analytical procedures from R&D, analytical development, or outside laboratories into BriaCell's GMP QC laboratory
- Assess method maturity and intended use; define sending/receiving laboratory responsibilities, risks, transfer strategy, equipment and material needs, staff training, and readiness criteria.
- Develop and execute approved method-transfer protocols with justified study design, samples, replicates, predefined acceptance criteria, deviation handling, and required documentation.
- Personally execute or directly oversee comparative testing and other scientifically appropriate transfer approaches; investigate method variability and technical gaps.
- Analyze transfer data; document discrepancies, conclusions, approvals, and readiness for routine testing in a final transfer report.
- Lead or support method qualification, verification, validation, and change-related reassessment as appropriate to the assay, development stage, and applicable requirements.
QC Laboratory Leadership and Operations
- Supervise, coach, train, and assign work to QC staff while retaining a meaningful personal laboratory testing workload
- Oversee sample receipt, chain of custody, testing plans, capacity, inventory, reagent management, reference standards, and laboratory workflow
- Ensure equipment qualification, calibration, preventive maintenance, instrument logs, and laboratory readiness are maintained
- Maintain and improve controlled testing procedures, laboratory records, equipment procedures, and efficient workflows.
- Monitor turnaround times, testing quality, assay trends, and resource needs; identify improvements that enable scale-up of late-stage clinical operations
GMP Compliance and Cross-functional Support
- Ensure testing and documentation comply with applicable cGMP, good documentation, and data integrity requirements
- Prepare, review, and approve technical QC documents and data within delegated authority and established independent-review controls.
- Lead scientific portions of OOS/OOT, atypical result, deviation, and assay-failure investigations, in collaboration with independent QA oversight; support CAPA and change control.
- Provide accurate release data and support Certificates of Analysis and other release packages; final product disposition remains with designated authorized Quality personnel.
- Support audits, inspections, regulatory documentation, contract testing laboratory oversight, and cross-functional problem solving.
Qualifications
- Bachelor's or master's degree in Biology, Cell Biology, Immunology, Biochemistry, Biotechnology, Molecular Biology, or another relevant scientific discipline; a PhD is not required.
- At least 7 years of relevant laboratory experience in biotechnology, biopharmaceuticals, or a closely related regulated setting, including extensive recent hands-on analytical testing experience.
- Substantial direct experience performing GMP release testing for biologics, cell therapies, or comparable complex biological products.
- Proven hands-on leadership of analytical method transfers, including planning, protocols, execution, acceptance criteria, troubleshooting, data evaluation, and transfer reports.
- Strong practical skills in relevant biological assays such as flow cytometry, immunoassays, cell-based potency/functional assays, and cell viability/count methods.
- Experience with analytical method qualification/verification/validation, GMP documentation, laboratory investigations, and data integrity.
- Experience overseeing laboratory operations and providing technical direction, training, or people supervision.
- Strong scientific judgment, technical troubleshooting, scheduling, communication, and ability to work in the lab while managing operational priorities.
Preferred Experience
Experience with allogeneic cell therapy, immuno-oncology products, or related advanced therapies.
Experience supporting Phase 3, commercial readiness, or scaling a small GMP QC laboratory
Familiarity with ICH Q2(R2), ICH Q14, USP <1224>, and relevant method transfer principles
Experience coordinating contract testing laboratories, regulatory inspections, LIMS, or electronic laboratory systems
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.