MSAT Scientist I
OmniaBio Inc, a subsidiary of Toronto-based CCRM, is a contract development and manufacturing organization (CDMO) producing gene-modified cell therapies and viral vectors, compliant with cGMP standards.
The facility has support from the Government of Ontario, via the Invest Ontario Fund, and is the first project to be funded through the Life Sciences Strategy. The facility will be built in phases with the ultimate goal of building the largest facility of its kind in Canada (over 350,000 sq ft). OmniaBio is Canada’s first commercial-scale CDMO dedicated to cell and gene therapies.
Located on the biomanufacturing campus at McMaster Innovation Park (Hamilton, ON), OmniaBio will catalyze life sciences careers and innovation in Canada while advancing pioneering medicine with the potential to cure, not just treat, many forms of cancer, cardiovascular diseases, Parkinson’s, and diabetes, amongst others. OmniaBio will support a broad range of cell and gene therapy companies globally, enabling pivotal/Phase III and commercial-scale manufacturing. OmniaBio will complete CCRM’s continuum of process development, clinical and commercial capabilities. CCRM is a leader in developing and commercializing regenerative medicine-based technologies, and cell and gene therapies.
This is a critical role that oversees all the cell and gene therapy GMP manufacturing operations and technology transfer activities. As the Manufacturing Sciences and Technology (MSAT) Scientist I at OmniaBio, you are a seasoned individual in manufacturing cell and gene therapy products under Good Manufacturing Practices (GMP) who is driven by the opportunity to enable the clinical translation of cell therapy and regenerative medicines. This challenging position is available in the process transfer and support function of MSAT at our Toronto facility. This position is responsible for being the primary technical support person for manufacturing processes. This position needs to thoroughly understand the manufacturing process, aseptic handling, process mapping, risk analysis, process implementation and other technology transfer related issues. The MSAT Scientist I is expected to actively participate in planning and problem solving. Our MSAT Scientist I is responsible for the execution of all the technology transfer studies in support of cGMP activities in GMP manufacturing. The MSAT Scientist I will work collaboratively with other departments during the technology transfer process and the individual will be involved in training other MSAT associates.
- Execution of MSAT laboratory studies in the lab to support cGMP activities at manufacturing scale.
- Drive process transfer and continued process support as per agreed timeline in close collaboration with internal and external parties.
- Accountable for the introduction and support of qualification of new process technologies into cGMP manufacturing, while managing technical risks associated with process transfer.
- Review client manufacturing process, standard operating procedures, Bill of Equipment and Bill of materials for GMP manufacturing compliance as part of the client facing technology transfer team.
- 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. Manage the transfer of complex processes from international development and pilot scale facilities.
- Perform all functions associated with process transfer and process support, for example: develop process understanding; perform gap analysis / Failure Mode Effects Analysis (FMEA); generate process models; author and/or review process descriptions, batch records and 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.
- Ensure major steps of process transfer including feasibility run, engineering runs and aseptic process simulation runs 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. Identify the potential root causes using a systematic approach and potential solutions. Understand all types of complex data analysis such as multiple linear regression analysis, analysis of variance (ANOVA) and multivariate analysis.
- Provide support for the manufacturing floor regarding pre-campaign training, support during critical manufacturing operations, troubleshooting, etc.
- Awareness 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 the performance of the manufacturing process.
- Provide training and guidance to other MSAT associates in areas of expertise or gained experience.
- Lead projects related to induced pluripotent stem cell reprogramming, immune-oncology, viral vector production
- 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.
- The individual is a subject matter expert for relevant ATMP processes.
- Have expertise in giving presentations, producing white papers, or other formats to communicate the organization’s expertise to our industry colleagues and partners.
- Extensive knowledge in the field of cell and gene therapy and applicable technologies: GMP, advanced therapeutic medicinal products (ATMP) and aseptic manufacturing.
- This position requires experience working in a fast-paced environment and composure when encountering unexpected events.
- Experience in induced pluripotent stem cell reprograming or immuno-oncology is essential and viral vector manufacturing is preferred.
- Prior biotech industry experience in process development and process scale up / downstream manufacturing is preferred.
- Basic knowledge of cell biology, cell culture, scale up and technology transfer and bioreactor operations is highly preferred. Experienced in aseptic technique and familiarity with mammalian cell culture.
- Strong understanding of cell manufacture processes and technologies.
- Strong experience with upstream and/or downstream processes.
- Strong English written and oral communication.
- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as cGMP, ISO, or medical device development.
- Experience establishing customer-facing organizations and service models.
- Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
- Take a collaborative approach to working with cross-functional teams, with good multicultural awareness.
OmniaBio Inc. is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
OmniaBio Inc. is committed to accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.
- Pay Type Salary