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.

Please kindly send your resumes to careers@briacell.com

****Must be authorized to work in the US under any employer****

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.

Please kindly send your resumes to careers@briacell.com