Scientific Lead, Manufacturing Science and Technology
7 hours ago
**Job Title**: Scientific Lead, Manufacturing Science and Technology (MSAT)
**Reports to**: Associate Director MSAT, Process Sciences and Analytical Development (PS&AD)
**Position Summary**:
As a Scientific Lead, MSAT, you will contribute in the support of cell and gene therapy cGMP activities, which include technology transfer, process optimization, and validation. Working closely with the Associate Director, MSAT and other PS&AD leaders, this position will also provide leadership and support to the identification, evaluation, sourcing, and maturation of new innovative technologies. The responsibilities of this role include providing technical leadership in client-facing projects and/or OmniaBio’s strategic projects, implementing the technology transfer processes and policies of our Hamilton facility, coordinating with the cross-functional team on the evaluation and translation of manufacturing processes, and assisting in establishing long term group direction and objectives.
Technology transfer into cGMP is a significant focus of this role, with programs ranging from internal transfer from our development teams to external transfers direct from client sites. You will ensure process scalability and manufacturability within our Hamilton facility.
**OmniaBio Overview**:
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. OmniaBio has support from the Government of Ontario, via the Invest Ontario Fund, and is the first project to be funded through the province’s Life Sciences Strategy. The facility will be built in phases and is expected to be the largest of its kind in Canada. OmniaBio will be Canada’s first commercial-scale CDMO dedicated to cell and gene therapies (CGTs). 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 other diseases. OmniaBio will support a broad range of CGT companies globally, enabling Phase I to commercial-scale manufacturing.
**Responsibilities**:
**_ MSAT_**
- Provide project leadership across a variety of modalities and technical disciplines, with a focus on cell and immunotherapies, induced pluripotent stem cells (iPSCs), and lentiviral vectors platforms, with support to gene editing, cell banking, and other innovative platform technologies.
- Support the introduction and qualification of new process technologies into cGMP manufacturing, while managing technical risks associated with process transfer. Lead cross-functional teams to ensure relevant transfer and communication of critical processes and technical risks such that successful outcomes are achieved.
- Author and review technical documentation related manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
- Maintain systems to continuously monitor, analyze, and optimize process performance and support and support Quality events, including change controls, investigations, and CAPAs. Imbedding key skills for investigation of non-conformance and root cause derivation. Escalating anomalies and concerns utilizing judgement as a seasoned leader.
- Collaborate and provide leadership within cross-functional teams, including the client, Process Development, Manufacturing, and Project Management to ensure on-time delivery of technology transfer activities.
- The activities include but are not limited to: performing process gap analysis; fit-to-plant; equipment and process characterization and scale-up; Failure Modes and Effects Analysis (FMEA)-based risk assessment; and drafting, review and approval of production batch records.
- Support investigations and continuous improvement initiatives, including oversight of the planning, execution and analysis of experiments at the manufacturing scale and using qualified scale-down models, in collaboration with other experts within PS&AD and other technical business units as required.
- Define, review and approve process-related documents (i.e., process overview, aseptic process simulation (APS) protocols, development/investigative protocols, and reports).
- Establish phase-appropriate and seamless process knowledge transfer from R&D/PD to clinical manufacturing, thereby achieving high manufacturing success rates and on-time regulatory approvals.
**_ Operational_**
- Support the implementation of a production strategy for contract manufacturing services for cell therapy (autologous and allogeneic cell and gene therapies) and viral vector production for our clients
- Work collaboratively with PS&AD, GMP Operations, Facility, Quality units, Supply Ch
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Hamilton, Ontario, Canada OmniaBio Full timeJob Title: Scientific Lead, Manufacturing Science and Technology (MSAT)Reports to: Associate Director MSAT, Process Sciences and Analytical Development (PS&AD)Position Summary:As a Scientific Lead, MSAT, you will contribute in the support of cell and gene therapy cGMP activities, which include technology transfer, process optimization, and validation....
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Hamilton, Canada OmniaBio Full timeJob Title: Scientific Lead, Manufacturing Science and Technology (MSAT) Reports to: Associate Director MSAT, Process Sciences and Analytical Development (PS&AD) Position Summary: As a Scientific Lead, MSAT, you will contribute in the support of cell and gene therapy cGMP activities, which include technology transfer, process optimization, and validation....
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