Msat Associate Scientist Ii

6 months ago

Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
**Job Title**: MSAT Associate Scientists I/II (Cell Therapy)

Position Summary
This is a critical role that oversees all of the cell and gene therapy technology transfer activities from process development to Good Manufacturing Practices (GMP) at CCRM. As the Associate Scientist I of the Manufacturing Sciences and Technology (MSAT) function, you are a seasoned individual in the field of GMP manufacturing of cell and gene therapy products who is driven by the opportunity to enable the clinical translation of cell therapy and regenerative medicine. This challenging position is available in the MSAT function of CCRM’s Centre for Cell and Vector Production (CCVP) facility. The position involves being the primary technical support person for manufacturing processes. The role will provide direction and process oversight. The Associate Scientist I, MSAT will be responsible for the execution of technology transfer studies in support of GMP activities in the CCVP facility. The role may also require providing guidance to operations personnel.

**Responsibilities**:

- Execute external and internal projects to support GMP activities at the manufacturing scale.
- Perform all functions associated with technology transfer and process support (e.g. develop process understanding, perform gap analysis and / Failure Mode Effects Analysis (FMEA), generate process models, author and review process descriptions and batch records, change controls, perform process monitoring, and data summary and analysis).
- Review client manufacturing process or standard operating procedure (SOPs), bill of equipment and bill of materials for GMP manufacturing compliance.
- Analyze and manage the risks associated with technology transfer, and the introduction of new raw materials for both pilot and production scale batches.
- Transfer complex processes from local and international development and pilot-scale facilities.
- Responsible for the creation of a master batch record (MBR) of the process, making revisions when required.
- Responsible for the successful transfer of Viral Vector and cell therapy Processes into GMP production.
- Support deviation investigations. Identify root cause using a systematic approach and identify Corrective and Preventative Actions (CAPAs).
- Understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, and multivariate analysis.
- Work cross-functionally to ensure communication and collaboration of technical information for critical processes meet required deadlines and customer service outcomes.
- Coordinate with various internal and external stakeholders to effectively communicate study plans and outcomes to maintain commercial manufacturing timelines.
- Train GMP operations and manufacturing personnel.
- Would be participating in the development or pilot, feasibility and engineering runs, and the oversight of GMP manufacturing runs.
- Responsible for the execution of designed protocol experiments via written process documentation prepared in collaboration with internal team members and other attributes as required.
- Work cross-functionally to ensure communication and collaboration of technical information for critical processes meet required deadlines and customer service outcomes
- The role will initiate Material Specifications, generate Technology Transfer documents (e.g., protocols, reports, process summary), perform process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports, and recommend improvements for MSAT practices and procedures.
- The role collaborates with cross-functional teams, including Process Development (PD), Operations/Manufacturing, Quality Assurance, Supply Chain, and Program Management among others to ensure on-time delivery of Technology Transfer activities.

**Requirements**:

- BSc with 2+ years of experience in Biological Sciences, Biomedical/Chemical Engineering/GMP, or another relevant field; MSc with 1+ years of experience or PhD in Biological Sciences, Biomedical/ Chemical Engineering/GMP, or another relevant field is preferred.
- Experienced in aseptic technique and familiarity with mammalian cell culture.
- Strong understanding of cell manufacturing processes and technologies.
- Strong experience with upstream and/or downstream processes.
- GMP experience and understanding of bioprocess technology.
- Strong English written and oral communication skills.

Desired Characteristics
- Strong understanding of, and experience in, executing induced pluripotent reprogramming, immune-oncology and viral vector production processes
- Prior biotech industry experience in process development and process scale-up manufacturing
- Prior experience with cell biology, cell culture, scale-up and mass transfer, bioreactor operations
- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO standards, or medical devi

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