Quality Control Lead, Arnie Charbonneau Cancer
3 months ago
**Description**
This position reports to the Associate Director of Biomanufacturing at the Riddell Centre and is part of the Riddell Centre for Cancer Immunotherapy (Riddell Centre).
The mission of the Riddell Centre is to reduce the burden of cancer and improve patient survival through the rapid development and implementation of safe and effective immunotherapies. The Biomanufacturing Program supports this mission by producing high-quality cell therapeutics and supportive reagents for preclinical research, product development, and clinical translation.
**Summary of Key Responsibilities** (job functions include but are not limited to):
- Quality Control Management:
- Work with Biomanufacturing Program leadership to oversee all QC activities, ensuring strict adherence to cGMP standards in the production of cell and immune therapies
- Manage the development, implementation, and maintenance of QC protocols, including comprehensive testing procedures, sample management, and release criteria
- Support the QC team, ensuring all tasks are executed with precision and within designated timelines
- Train and mentor technical staff on equipment operation, QC procedures, and best practices to ensure consistency and accuracy in all QC processes
- Collaboration & Communication:
- Collaborate with key internal and external stakeholders, including partners within the Riddell Centre, Alberta Precision Laboratories, Alberta Health Services, and other academic and industry collaborators, to ensure the seamless operation of QC processes
- Act as the primary point of contact for audits related to QC activities, ensuring that all documentation is compliant with regulatory standards and ready for inspection
- Regulatory Compliance:
- Ensure that all QC processes and documentation are fully compliant with GxP regulations (GDP, GLP, GMP) and align with Health Canada, FDA, and ICH guidelines
- Lead the preparation, review, and continuous improvement of QC-related documents, including standard operating procedures, validation reports, and quality records
- Continuous Improvement & Problem Solving:
- Identify and resolve QC issues promptly, implementing corrective actions to prevent recurrence and maintain high standards
- Drive continuous improvement initiatives, enhancing the efficiency, accuracy, and compliance of QC operations
- Stay current with evolving regulations and industry standards by attending relevant meetings, conferences, and workshops, ensuring that QC practices remain aligned with the latest requirements and best practices
- Safety & Risk Management:
- Ensure all QC activities are conducted safely, following established protocols to minimize risk and ensure the safety of the team and the integrity of the products
- Perform regular risk assessments, proactively identifying potential hazards and developing strategies to mitigate them effectively
- General Responsibilities:
- Preparedness to manage additional work hours and high-stress situations, ensuring the consistent delivery of high-quality outputs
- Manage lab equipment and inventory systems to ensure operational efficiency
- Ensure proper calibration and maintenance of QC instruments
**Qualifications / Requirements**:
- Ph.D. or equivalent in Immunology, Biotechnology, Cell Biology, or a related field
- Prior QC experience in a biomanufacturing or pharmaceutical environment is an asset
- Experience managing QC operations within a GMP-regulated environment, including hands-on experience with assay development, validation, and sample management, is an asset.
- Strong self-directed learning skills with the ability to efficiently acquire new techniques and adapt to emerging technologies and methodologies
- Proficiency in QC techniques such as ELISA, PCR, ddPCR, sequencing, and cell-based assays, with the ability to analyze and interpret complex data sets
- Experience designing and conducting multi-parameter flow cytometry experiments and cell sorting, ensuring accurate and reliable results
- Expertise in aseptic techniques and microbial testing to maintain contamination-free environments.
- Skilled in conducting sterility assays and interpreting results in alignment with regulatory standards to ensure product safety
- Strong ability to lead and mentor a small team, fostering a collaborative and productive work environment
- Excellent organizational and project management skills, enabling effective prioritization and timely completion of tasks under tight deadlines
- Advanced problem-solving skills, with the capability to address complex issues within a dynamic regulatory landscape
- Knowledge of GxP regulations, including GDP, GLP, GMP, and familiarity with relevant Health Canada, FDA, and ICH guidelines is an asset
**Application Deadline**: October 11, 2024
This position is part of the AUPE bargaining unit, and falls under the **_Technical Job Family, Phase 3_**.
For a listing of all management and staff opportunities at the University of Calgary, vie
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