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.

Visit www.omniabio.com to learn more.

Position Summary:

The Senior Manager, GMP Manufacturing Operations provides leadership for multi-shift GMP manufacturing operations supporting clinical and commercial cell and gene therapy programs at OmniaBio's Hamilton facility. Reporting to the Senior Director, Operations, the role is accountable for the safe, compliant, and efficient execution of manufacturing activities, with ownership of Manufacturing Safety, Quality, Delivery, Cost, and People (SQDCP) performance. Working closely with clients and cross-functional leaders, the Senior Manager leads Manufacturing Supervisors and oversees staffing, operational readiness,



manufacturing performance, compliance, capacity planning, and continuous improvement initiatives to ensure successful delivery of client programs and commercial operations. This position serves as the operational counterpart to Technical Operations and may require support outside regular business hours to meet manufacturing and client commitments.

Responsibilities:

Manufacturing Operations Leadership

- Lead all routine GMP manufacturing activities supporting clinical and commercial manufacturing programs
- Accountable for Safety, Quality, Delivery, Cost, and People (SQDCP) performance across all GMP Manufacturing Operations
- Establish operational priorities and allocate resources to optimize manufacturing performance and capacity utilization to ensure manufacturing OTIF delivery
- Act as the senior operational escalation point for manufacturing execution issues and business-critical manufacturing decisions
- Drive a culture of accountability, operational excellence, and continuous improvement throughout the manufacturing organization
- Ensure manufacturing campaigns are executed safely, compliantly, and in accordance with approved procedures, schedules, and client commitments.

People Leadership & Organizational Development

- Lead, coach, mentor,



and develop Manufacturing Supervisors and associated manufacturing teams supporting multi-shift operations.
- Foster a high performing, collaborative, and accountable team culture by modeling company values and expected leadership behaviors
- Manage workforce planning, succession planning, talent development, performance management, employee engagement, and organizational capability development.
- Ensure appropriately trained, qualified, and competent resources are available to support current and future manufacturing activities.
- Support recruitment, onboarding, retention, and leadership development initiatives across the Manufacturing organization.
- Promote diversity, equity, inclusion, and belonging within the team.

Quality, Compliance & Manufacturing Documentation

- Ensure all manufacturing activities are conducted in accordance with GMP regulations, approved procedures, and Positive Documentation Practices.
- Ensure department provides required Support for Internal Service Level Agreements (SLA) for batch release and quality events
- Maintain manufacturing inspection readiness and support client, regulatory, and internal audits.
- Ensure Master Batch Records and manufacturing documentation appropriately support compliant and efficient manufacturing execution.
- Ensure executed batch records comply with ALCOA+ principles and documentation issues are escalated and resolved in a timely manner.
- Provide manufacturing leadership and resources for investigations, root cause analyses, CAPAs, and quality event management activities.

Manufacturing Facilities, Equipment & Operational Readiness

- Ensure manufacturing equipment is available and maintained in a safe, compliant, and operationally ready state.

📌 Senior Manager, Manufacturing (Canada)
🏢 OmniaBio
📍 Canada