Cell Manufacturing Lead

Mote Marine Laboratory; Calgary; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leading medical institution is seeking a Cell Manufacturing Lead to oversee the manufacturing of clinical-grade cell therapies. This role involves leading a new cGMP therapy facility, ensuring regulatory compliance, and requires a Ph.D. with extensive experience in cell therapy. The position is pivotal for enhancing cancer treatment efficacy through innovative therapies.

Qualifications

• Extensive experience in cell therapy manufacturing, including T cell culture.
• Proven leadership in GMP-regulated environments.
• Deep expertise in aseptic cell culture and genetic modification.

Responsibilities

• Lead GMP-compliant manufacturing of CAR T and other cell-based therapies.
• Collaborate with process development teams for manufacturing protocols.
• Ensure manufacturing activities adhere to cGMP, GDP, and GLP standards.

Skills

Cell Culture

Manufacturing Process Development

Leadership

Problem Solving

Regulatory Compliance

Education

Ph.D. in Cell Biology, Biotechnology, Immunology, or related field

Tools

CliniMACS Prodigy

Flow Cytometry

ELISA

PCR

Job description

The Arnie Charbonneau Cancer Institute in the Cumming School of Medicine invites applications for a Cell Manufacturing Lead. This Full-time Fixed Term position is for approximately 12 months (based on length of grant funding), with the possibility of extension.

This position reports to the Associate Director of Biomanufacturing at the 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.

The Cell Manufacturing Lead will be responsible for the production of clinical-grade cell therapies in support of early-phase clinical trials, including CAR T cell manufacturing. In the near term, this role will coordinate manufacturing activities in collaboration with the FACT-accredited Cell Therapy Lab (CTL) within Alberta Precision Laboratories (APL). In parallel, the successful candidate will lead the commissioning and operational launch of a new cGMP cell therapy facility at the Riddell Centre¿establishing scalable, long-term manufacturing capabilities.

This position operates at the interface of research and clinical application, with close collaboration across internal teams in process development, quality control, quality assurance, and regulatory affairs, as well as external partners such as APL and Alberta Health Services (AHS). It is ideally suited to a candidate with both technical expertise and leadership experience, ready to help shape and deliver a high-impact cell therapy manufacturing program.

Summary of Key Responsibilities (job functions include but are not limited to):

Cell Manufacturing Leadership:

- Lead GMP-compliant manufacturing of CAR T and other cell-based therapies
- Coordinate with CTL to ensure uninterrupted production for ongoing trials
- Guide the design, commissioning, and operational readiness of the Centre¿s cGMP manufacturing lab
- Develop training programs and ensure staff maintain consistent technical competency and compliance

Process Development & Optimization

- Collaborate with process development teams to implement robust and scalable manufacturing protocols
- Support tech transfer and scale-up activities from development to clinical production
- Identify and implement process optimizations to improve quality, efficiency, and cost-effectiveness

Collaboration & Communication

- Maintain strong relationships with internal teams and external collaborators to support seamless production
- Serve as the point of contact for audits, inspections, and manufacturing-related external communications

Regulatory Compliance

- Ensure all manufacturing activities and documentation adhere to cGMP, GDP, and GLP standards, aligned with Health Canada, FDA, and ICH guidelines
- Lead the preparation, review, and ongoing improvement of manufacturing documents (SOPs, batch records, training materials)

Continuous Improvement & Problem Solving

- Resolve manufacturing issues promptly, using CAPAs and root cause analysis when needed
- Remain informed of evolving regulatory and technical standards through ongoing training and conference participation

Safety & Risk Management

- Ensure all manufacturing activities are conducted safely, following established protocols to minimize risks
- Perform regular risk assessments and implement necessary mitigation strategies

Qualifications / Requirements:

- Ph.D. in Cell Biology, Biotechnology, Immunology, or a related field
- Extensive experience in cell therapy manufacturing, including T cell culture and genetic modification (e.g., transduction, electroporation)
- Proven leadership in GMP-regulated environments, including oversight of technology transfer and clinical-scale production
- Strong self-directed learning skills with the ability to efficiently acquire new techniques and adapt to emerging technologies and methodologies
- Deep expertise in aseptic cell culture, including cell isolation, expansion, and cryopreservation
- Experience with closed-system platforms such as CliniMACS Prodigy or similar automated systems
- Proficiency in in-process and final product testing methods (e.g., flow cytometry, ELISA, PCR)
- Familiarity with electronic batch records (EBRs) and Quality Management Systems (QMS)
- Demonstrated experience leading and mentoring technical staff in a regulated environment
- Strong organizational and project management skills to manage competing priorities under tight timelines
- Effective problem-solving and decision-making in complex, dynamic settings
- In-depth understanding of GxP regulations (GMP, GLP, GDP), with working knowledge of Health Canada, FDA, and ICH guidelines

This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase 3.

Apply here:Cell Manufacturing Lead