Quality Control Specialist, ATMF

Job Summary

The Advanced Therapeutics Manufacturing Facility (ATMF) is a new CFI-funded project and part of Canada’s Immuno-Engineering and Biomanufacturing Hub (CIEBH), a UBC-led national research hub that aims to align the critical mass of immune-engineering with biomanufacturing and public health strengths concentrated in BC. This multi-year, multi-phase initiative aims to build a Good Manufacturing Practice (GMP) biomanufacturing core facility to produce advanced therapeutics - such as cells, mRNA vaccines, and ancillary plasmid DNA - essential for early-phase clinical trials, addressing current health challenges, and strengthening Canada’s pandemic preparedness.

The Quality Control (QC) Specialist, ATMF is responsible for developing and executing the analytical testing that supports ATMF's advanced therapeutic products, including RNA therapeutics, cell therapies, and viral vectors.

Working within a Good Manufacturing Practice (GMP) compliant facility, this role performs QC release and stability testing to support translational research and clinical trials. Under the general direction of facility leadership, the incumbent coordinates the optimization of phase-appropriate QC assays and analytical methods in accordance with International Council for Harmonisation , United States of Pharmacopeia , and European Pharmacopeia guidelines, drafts standard operating procedures, and maintains the technical organization of QC laboratory operations.

The QC Specialist reports directly to the Director, GMP Operations, Quality and Regulatory, ATMF. The incumbent works in close collaboration with the ATMF Process Development (PD) and GMP production teams, Quality Assurance (QA) personnel, and academic partners to support the timely testing and release of translational products.

Organizational Status
The University of British Columbia is a global centre for research and teaching, consistently ranked among the top 20 public universities in the world. Since 1915, UBC’s entrepreneurial spirit has embraced innovation and challenged the status quo. UBC encourages its students, staff

and faculty to challenge convention, lead discovery and explore new ways of learning. At UBC, bold thinking is given a place to develop into ideas that can change the world.

Our Vision: To Transform Health for Everyone

Ranked among the world’s top medical schools with the fifth-largest MD enrollment in North America, the UBC Faculty of Medicine is a leader in both the science and the practice of medicine. Across British Columbia, more than 12,000 faculty and staff are training the next generation of doctors and health care professionals, making remarkable discoveries, and helping to create the pathways to better health for our communities at home and around the world.

The Faculty - comprised of approximately 2,200 administrative support, technical/research and management and professional staff, as well approximately 650 full-time academic and over 10,000 clinical faculty members - is composed of 19 academic basic science and/or clinical departments, 3 schools, and 25 research centres and institutes. Together with its University and Health Authority partners, the Faculty delivers innovative programs and conducts research in the areas of health and life sciences. Faculty, staff and trainees are located at university campuses, clinical academic campuses in hospital settings and other regionally based centres across the province.

The UBC Vancouver Campus is located on the traditional, ancestral, and unceded territory of the xʷməθkʷəy̓əm (Musqueam) people. The City of Vancouver is located on Musqueam, Squamish, and Tsleil-Waututh First Nations territory.

The QC Specialist is a member of the ATMF GMP Operations team and reports to the Director, GMP Operations, Quality and Regulatory. The position interacts closely with Process Development, GMP Production, Quality Assurance, and academic collaborators to facilitate quality control operations and support the timely advancement and release of translational products.

Work Performed
1. Assay Development & Tech Transfer Support

• Develops and optimizes analytical and functional QC procedures across the ATMF pipeline - RNA, cell therapy, viral vector - in line with ICH, USP, and EP guidelines.
• Writes and executes qualification and validation protocols for clinical-trial-enabling methods, including potency, purity, identity, safety, and impurity testing.
• Oversees tech transfer of analytical methods into the ATMF QC environment, whether coming from the PD lab or an external partner.
• Drafts SOPs, protocols, and technical reports for review and approval by QA and the Director.

2. QC Testing & Technical Operations

Performs analytical testing on clinical-grade, GMP- grade and investigational raw materials, in-process intermediates, and final drug products, using platforms appropriate to the relevant modality:

• qPCR, digital droplet PCR (ddPCR), capillary electrophoresis, and nucleic acid analysis.
• Multi-color flow cytometry, cell count/viability (using automated counters), and cell-based functional/potency assays.
• Dynamic Light Scattering (DLS), ELISA, Western Blotting, and spectrophotometry.
• Supports the development of stability protocols, organizes and tracks the ATMF stability program, and pulls and tests samples in accordance with approved stability protocols.
• Manages sample receipt, storage, distribution, and tracking for in-house and approved contract laboratory testing, including review of analytical data and test documentation.
• Troubleshoots analytical instrumentation and documents out-of-specification (OOS) or out-of-trend (OOT) test results for investigation.

3. GMP Compliance, Documentation & Equipment Qualification

• Maintains detailed, GMP-compliant documentation of all QC-laboratory activities to ensure complete data integrity.
• Executes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for QC laboratory instrumentation per approved protocols and under the direction of QA.
• Identifies, documents, and assists in investigating deviations, non-conformances, and OOS events; contributes technical data to help formulate corrective and preventive actions (CAPAs).
• Manages QC lab inventory including reagents, reference standards, controls - and associated ordering.
• Manages QC laboratory instrumentation maintenance and calibration.

4. Training & Technical Coordination

• Trains junior technical staff, research assistants, and trainees on QC assays, analytical methods and GMP documentation.
• Provides input into the design of QC workflows, laboratory layout, and data management systems.
• Serves as a technical resource for QC-related questions during internal audits and regulatory inspections, escalating to the Director as needed.
• Assists ATMF leadership in prioritizing daily testing schedules and tracking project timelines.

Consequence of Error/Judgement
The QC Specialist works under minimal supervision and is expected to exercise sound technical judgment and compliance awareness day to day.

This role contributes testing data and technical assessments that inform batch disposition decisions made by QA. Errors in technique, data recording, or judgment at this stage increase risk downstream, though such errors are also subject to independent QA review prior to product release. Consequences may include:

• Repeat testing or delayed batch disposition timelines due to testing errors or incomplete documentation.
• Additional QA review or investigation triggered by incomplete, inconsistent, or late QC records.
• Contribution to audit or inspection findings if GMP documentation standards are not consistently maintained.

Accordingly, attention to detail and consistent documentation practices are core expectations of the role.

Supervision Received
The position reports to the Director, GMP Operations, Quality and Regulatory, ATMF, receiving general direction on project milestones and priorities. The incumbent is expected to work independently on day-to-day assay execution, optimization, and troubleshooting.

Supervision Given
No direct reports. The role does include peer training and technical guidance for junior technicians, graduate students, and facility trainees.

Minimum Qualifications
Completion of a university degree in a relevant discipline or technical program and a minimum four years of related experience or an equivalent combination of education and experience. Some positions may require a graduate degree.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

University degree in a relevant discipline (Biochemistry, Molecular Biology, Immunology, Biotechnology, or similar) plus a minimum of four years of related laboratory experience, or an equivalent combination of education and experience. Relevant graduate coursework or an M.Sc. may be considered an asset.

Technical & Regulatory Experience

• GMP/GLP experience in a regulated cleanroom environment (Grade A/B/C/D) within biomanufacturing, pharma, or biotech.
• Demonstrated experience developing, troubleshooting, and validating analytical methods in accordance with ICH, USP, and EP guidelines.
• Demonstrated proficiency across multiple modalities, including RNA therapeutics (DLS, encapsulation efficiency, particle size, Ribogreen, RNA integrity), cell therapy (multi-color flow cytometry, complex gating strategies, viability, phenotypic characterization), and viral vectors (qPCR/ddPCR physical titer, infectivity/transduction assays, ELISA for HCP/hcDNA clearance).
• Demonstrated experience in developing and executing stability studies in accordance with ICH guidelines.

Experience authoring and executing IQ/OQ/PQ protocols for laboratory instrumentation.

Professional & Communication Skills

• Comfortable coordinating across teams and mentoring others through experimental protocols.
• Demonstrated ability to conduct OOS/OOT investigations and contribute to root cause analysis.
• Strong organization skills, technical writing skills (SOPs, deviations, validation and stability protocols) and clear verbal communication across multi-disciplinary teams.
• Contributes to a collaborative, respectful, and inclusive laboratory environment.

Equity and Diversity

UBC hires on the basis of merit and is strongly committed to equity and diversity within its community. We especially welcome applications from visible minority group members, women, Indigenous persons, persons with disabilities, persons of minority sexual orientations and gender identities, and others with the skills and knowledge to productively engage with diverse communities.