Senior Scientist, Quality Control - Cell Therapy
hace 15 días
Philadelphia
Job Description 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-IMTTM, 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-IMTTM is a targeted cell-based immunotherapy. Bria-OTSTM, 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: www.briacell.com 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., • Direct hands-on experience working within or closely supporting a GMP Quality Control function., • Demonstrated ownership of analytical method qualification and/or validation in a regulated environment., • 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., • Ability to work effectively in a fast-paced, collaborative small-biotech environment while remaining highly engaged in hands-on laboratory work. Preferred Qualifications • Experience supporting late-stage clinical, Phase 3, or commercialization-readiness program, • 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 visit www.briacell.com and click on “About Us” to submit your application through the Careers section. 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. \nCompany Description 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. 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.