OmniaBio : Scientific Lead, Manufacturing Science & Technology (MSAT)

OmniaBio : Scientific Lead, Manufacturing Science & Technology (MSAT)

Hamilton, ON, Canada

Job Description

Posted Friday, November 28, 2025 at 5 : 00 AM

About OmniaBio :

OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting‑edge therapies worldwide. Visitwww.omniabio.com to learn more.

Position Summary

As a Scientific Lead, MSAT, you will oversee cell and gene therapy Good Manufacturing Practices (GMP) Manufacturing Science and Technology (MSAT) activities, which include technology transfer, process optimization and validation. 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 the following : providing technical leadership in client‑facing projects and / or OmniaBio’s strategic projects; establishing technology transfer processes and policies; promoting manufacturing operations interactions; providing technical input and guiding manufacturing strategy; coaching and mentoring employees; prioritizing work; and, assisting in establishing long‑term group direction and objectives. The focus of this role is to lead a team of MSAT Scientists and Associate Scientists who are supporting allogeneic cell and gene modified cell therapy product manufacturing processes through the planning, execution and analysis of at‑scale and scale‑down experiments to enhance process understanding and performance. You will serve as a subject‑matter expert in client‑facing scope discussions, developing internal business processes, and writing standard operating procedures (SOPs), along with protocols and reports. This position will directly contribute to the successful delivery of products in support of numerous clinical trials.

As a leader of the MSAT Team, you are responsible for the successful transfer of processes into production. As such, you are in direct contact with our clients and process development (PD) scientists. You ensure process scalability and manufacturability. In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes.

Responsibilities

MSAT

• Provide leadership and build a strong technical MSAT team supporting clinical and / or commercial manufacturing.
• Represent MSAT within multiple complex customer‑facing product project teams using a standard methodology / procedure to successfully transfer both existing and new technologies either into upstream processing (UPS) or downstream processing (DSP) of GMP cell and vector manufacturing from development through MSAT pilot scale.
• Provide leadership with a focus on induced pluripotent stem cells (iPSCs), gene editing, cell banking, CAR‑NKs and other innovative platform technologies and 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.
• Provide general and technical supervision to a group of MSAT Scientists and Associate Scientists whose responsibility it is to process technology transfer of cell and gene therapy (CGT) product manufacturing processes.
• Author and review technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions and product impact assessments.
• Be accountable for the introduction and support of qualification of new process technologies into cGMP manufacturing, while managing technical risks associated with process transfer; leading cross‑functional teams to ensure relevant transfer; and communication of critical process and technical information such that successful outcomes are achieved.
• Collaborate with 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, review and approval of production batch records.
• Review client manufacturing processes or SOPs, Bill of Equipment and Bill of materials for GMP manufacturing compliance.
• Design and analyze process fit and process‑scale up in collaboration with vendors, customer technical experts or OmniaBio’s Process Development teams.
• Define, review and approve process‑related documents (i.e., process overview, aseptic process simulation (APS) protocols, development / investigative protocols, and reports).
• Lead customer technical team meetings and serve as technical lead and SME at joint project team meetings.
• Provide technical leadership and support to cross‑functional project teams in areas of process tech transfer, process design and scale up, facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
• Lead the allogenic platform team in supporting manufacturing when troubleshooting processes on the manufacturing floor and during post‑operational investigations.
• 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 to Business Development

General Management

Requirements

Desired Characteristics

OmniaBio 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.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio 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.

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