Msat Scientist I

3 weeks ago


Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
**Department**: Deliver

Position Summary
This is a critical role that oversees all the cell and gene therapy Good Manufacturing Practices (GMP) operations and technology transfer activities. As the Manufacturing Sciences and Technology (MSAT) Scientist I at CCRM, you are a seasoned individual in the field of cell and gene therapy manufacturing processes, with experience following GMP and driven by the opportunity to enable the clinical translation of cell therapy and regenerative medicine. This challenging position is available in the process transfer and support function of MSAT at our Centre for Cell and Vector Production (CCVP) facility. In this position you are the primary technical support person for manufacturing processes and must thoroughly understand the manufacturing process, aseptic handlings, process mapping, risk analysis, process implementation and other technology transfer related issues. The MSAT Scientist I is expected to actively participate in the planning and problem-solving of technology transfer related issues and the execution of all technology transfer studies in support of GMP activities at the GMP facility. The MSAT Scientist I will work in cooperation with other departments during the technology transfer and the individual will be involved in training other MSAT associates.

**Responsibilities**:

- Execution of MSAT laboratory studies in the lab to support GMP activities for downstream viral vector manufacturing at small and large scale.
- Drive the process transfer and provide process support as per agreed timelines in close collaboration with internal and external parties.
- Responsible for the introduction and support of qualification of new process technologies into GMP manufacturing, while managing technical risks associated with process transfer.
- Review client manufacturing processes or standard operating procedures (SOPs), bill of equipment (BOE) and bill of materials (BOM) for GMP manufacturing compliance.
- Identify risks and develop mitigation plans in the downstream process and enable quick and robust decision-making through efficient team collaboration.
- Responsible for analyzing and managing the risks associated with process transfer, and the introduction of new raw materials for both pilot and production scale batches, and transfer complex processes from international development and pilot scale facilities.
- Perform all functions associated with process transfer and process support, e.g., develop process understanding; perform gap analysis/failure mode and effects analysis (FMEA); generate process models; author/review process descriptions and batch records, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation).
- Provide guidance on process transfer and support activities to members of the team.
- Prepare or review user requirement specifications (URS) of all new equipment and work closely with the Commissioning, Qualification and Validation (CQV) and facility teams to perform risk assessment or impact assessment.
- Ensure major steps of process transfer, including feasibility runs, engineering runs and APS runs and that they are performed successfully.
- Participate in troubleshooting and serve as investigation lead for process impacting deviations and investigations.
- Provide technical guidance on change controls and how they might impact customer processes.
- Assess all major deviations, including those that impact product quality:

- Identifies potential root causes using a systematic approach;
- Able to identify potential solutions;
- Performs or can understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis;
- Provide support for the manufacturing floor regarding pre-campaign training, support during critical manufacturing operations, troubleshooting, etc.
- Provide expertise in presentations, white papers, or other formats to communicate the organization’s expertise to our industry colleagues and partners
- Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applied to process innovation, cost, or yield improvement.
- Keep current with advances in the cell and gene therapy field.
- Collaborate with process development teams on improving performance.
- Provide training and guidance to other MSAT associates and must be able to independently perform deliverables assigned to the individual.
- Lead projects related to induced pluripotent reprogramming, immune-oncology, viral vector production etc.

**Requirements**:

- BSc with 6+ years of experience in biological sciences, biomedical/chemical engineering/GMP, or another relevant field; MSc with 5+ years of experience or PhD with 4+ years of experience in biological sciences, biomedical/chemical engineering/GMP, or another relevant field is preferred.
- Solid knowledge and experience in viral


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