Senior Scientist, Bioanalytical Development - 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
Position Summary
We are seeking an experienced, highly motivated Senior Scientist, Bioanalytical Development to support late-stage (Phase 3) bioanalytical method qualification and validation, and the continued development of our cell therapy programs and advancement of our analytical capabilities.
The Senior Scientist, Bioanalytical Development will develop, optimize, qualify, and transfer bioanalytical methods to support BriaCell's clinical-stage cell therapy programs and future commercial manufacturing requirements.
This hands-on scientific position requires extensive experience in bioanalytical assay development, particularly multiparameter flow cytometry, cell-based potency assays, and analytical method qualification. The successful candidate will apply strong scientific judgment to characterize cell therapy products and evaluate critical quality attributes, including identity, purity, potency, and viability.
Working with Research and Development, Manufacturing, Quality Control, Quality Assurance, and external partners, this scientist will bridge development-stage assays with late-stage (Phase III) clinical and commercial analytical requirements.
Key Responsibilities
Bioanalytical Method Development and Optimization
- Independently design, develop, optimize, and execute bioanalytical assays for cell-based immunotherapies.
- Develop multiparameter flow cytometry methods, including panel design, gating strategies, controls, data acquisition, analysis, and troubleshooting.
- Develop and optimize cell-based functional and potency assays relevant to product biology and mechanism of action.
- Establish analytical methods for product identity, purity, potency, viability, and other critical quality attributes.
- Evaluate assay performance, variability, reproducibility, and robustness using appropriate experimental design and statistical analysis.
- Conduct laboratory experiments, interpret data, troubleshoot complex technical challenges, and recommend improvements.
Method Qualification, Validation, and Technology Transfer
- Lead or contribute to analytical method qualification, verification, and validation appropriate to intended use and stage of development.
- Develop and execute protocols evaluating relevant performance characteristics, including precision, accuracy, specificity, range, and robustness, as applicable.
- Define assay acceptance criteria, suitability requirements, controls, and critical reagent strategies.
- Lead analytical method transfers to internal QC teams, contract laboratories, and manufacturing partners, including comparative studies, troubleshooting, and transfer reports.
- Work with QC and QA to establish reliable, well-documented methods suitable for routine GMP use.
Clinical Development and Commercial Readiness
- Provide analytical support for product characterization, process development, comparability, and analytical control strategies.
- Develop or refine potency methods and other assays supporting late-stage clinical development and potential commercial manufacturing.
- Support analytical strategies for in-process controls, product release, stability, and characterization.
- Generate and interpret data and technical documentation supporting regulatory submissions and responses to health authority questions .
- Collaborate on critical quality attributes, analytical specifications, assay lifecycle management, and product comparability.
Scientific Collaboration and Technical Leadership
- Serve as a subject matter expert in flow cytometry, cell-based potency testing, and bioanalytical development.
- Collaborate with R&D, Process Development, Manufacturing, QC, QA, Regulatory Affairs, and external technical partners.
- Provide guidance and hands-on support to research associates and laboratory colleagues.
- Write analytical methods, protocols, technical reports, and scientific presentations; maintain accurate laboratory documentation.
Required Qualifications
- Master's degree or PhD in Cell Biology, Immunology, Molecular Biology, Biochemistry, Biotechnology, Bioengineering, or a related scientific discipline.
- Minimum of 8 years of relevant biotechnology or biopharmaceutical laboratory experience, including substantial hands-on bioanalytical method development.
- Extensive experience designing, optimizing, troubleshooting, and qualifying biological analytical methods.
- Demonstrated expertise in multiparameter flow cytometry, including panel design, instrument operation, gating, analysis, and assay troubleshooting.
- Demonstrated experience developing and optimizing cell-based functional or potency assays.
- Experience with analytical method qualification and/or validation, including protocols, execution, performance evaluation, and technical documentation.
- Experience with mammalian cell culture and analytical methods relevant to cell therapies.
- Understanding of assay controls, reproducibility, analytical performance, and data interpretation.
- Experience supporting biological products through clinical development or toward commercial manufacturing.
- Ability to independently design and execute experiments, solve complex technical problems, and communicate results.
Preferred Qualifications
- Direct experience with cellular immunotherapies, cancer immunology, or advanced cell therapy products .
- Experience developing and qualifying potency assays for cell-based therapeutics.
- Experience with GMP-facing method transfer, validation, assay lifecycle management, and comparability assessments.
- Familiarity with ICH Q2(R2), ICH Q14, and applicable FDA expectations for cell therapy analytical controls.
- Experience interacting with contract testing laboratories or CDMOs and supporting late-stage clinical or commercialization programs.
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.