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OmniaBio

Senior Manager, Manufacturing

Hamilton, ON, Canada

Pay: $135,000 to $145,000 CAD / year
Job type: Full-time
Apply by: Oct 24, 2026
Posting language: English
Posted: Sep 24, 2026

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Original job description

Active Vacancy

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.

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 Good 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.
Ensure classified manufacturing spaces remain in a controlled, clean, and inspection-ready condition suitable for GMP operations.
Support operational readiness for new manufacturing suites, equipment, technologies, and manufacturing capabilities.

Planning, Capacity & Business Operations

Partner with Supply Chain, Scheduling, Program Management, Technical Operations, and other functional groups to ensure manufacturing capacity, resources, equipment, and materials align with business objectives and are clearly represented in S&OP activities.
Support annual budgeting, operational planning, and manufacturing performance reporting.
Ensure effective utilization of SAP and other systems supporting manufacturing execution and business operations.

Continuous Improvement & Operational Excellence

Drive implementation of the OmniaBio Operating Model (OBOM) and continuous improvement initiatives within manufacturing operations.
Establish and monitor manufacturing KPIs including safety, quality, delivery, cost, productivity, training compliance, and batch performance.
Lead initiatives that improve efficiency, reduce waste, enhance reliability, and support manufacturing scalability.
Support deployment of digital manufacturing, automation, and operational excellence initiatives.

Client & Cross Functional Leadership

Serve as the operational manufacturing lead for active client programs and routine GMP manufacturing operations.
Collaborate closely with Technical Operations, Quality, MSAT, Supply Chain, Facilities & Engineering, CQV, Program Management, and Finance to ensure successful manufacturing execution.
Provide manufacturing leadership during client meetings, operational reviews, audits, and business planning activities.
Support commercialization, scale-up, and strategic operational initiatives that support OmniaBio's growth objectives.

Qualifications and experience:

Bachelor’s degree in related fields (life sciences or related engineering discipline)
12 years minimum of relevant manufacturing experience (GMP, cleanroom, biologics).
Minimum 5 years of supervisory/leadership experience, with large multi-shift team
Cell or gene therapy and/or CDMO experience required
Direct experience with regulatory bodies
Strong English written and verbal communication skills.

Desired Competencies and Behaviors:

Collaboration
Integrity
Resilience and Tenacity
Teamwork
Inter-personal awareness
High energy
Independence
Influencing
Leadership
Organizational awareness

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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More about this job

Responsibilities

Lead multi-shift GMP manufacturing operations for clinical and commercial cell and gene therapy programs, with accountability for safety, quality, delivery, cost, and people performance. Develop manufacturing teams, ensure compliance and operational readiness, manage capacity and client commitments, and drive continuous improvement and operational excellence.

Requirements

Requires a bachelor's degree in life sciences or a related engineering discipline, at least 12 years of relevant GMP, cleanroom, or biologics manufacturing experience, and at least five years of leadership experience managing large multi-shift teams. Cell or gene therapy and/or CDMO experience, direct experience with regulatory bodies, and strong written and verbal English communication skills are required.

Skills

GMP Manufacturing Operations
Cell And Gene Therapy Manufacturing
Multi-Shift Team Leadership
Operational Planning
Capacity Planning
People Management
Regulatory Compliance
Good Documentation Practices
Batch Record Management
Root Cause Analysis
CAPA Management
Continuous Improvement
Operational Excellence
Cross-Functional Collaboration
SAP

Visa sponsorship

Not detected in the job text

Keywords

GMP
Cell And Gene Therapy
CDMO
Cleanroom
Biologics
Manufacturing Operations
SQDCP
OTIF
Good Documentation Practices
ALCOA+
Master Batch Records
CAPA
Root Cause Analysis
Regulatory Audits
SAP
S&OP
Operational Readiness
Capacity Planning
Continuous Improvement
OmniaBio Operating Model
Digital Manufacturing
Automation
Robotics
Artificial Intelligence
Scale-Up
Commercialization
Lentiviral Vectors
Immune Cell-Based Therapies

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