OmniaBio: Manufacturing Project Lead

Posted Friday, January 16, 2026 at 5:00 AMAbout 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.Active VacancyRole Summary:The Manufacturing Project Lead is responsible for leading a team of manufacturing associates in the execution of cell and gene therapy production projects within the cleanroom environment. This role will be integral part of tech transfer and work closely with MSAT to onboard client projects and develop project specific training for the execution team. This role serves as the subject matter expert (SME) for manufacturing processes and activities, ensuring compliance with GMP standards and supporting continuous improvement. The Project Lead acts as the primary technical resource for the team and provides oversight and mentorship to assigned staff at OmniaBio’s Hamilton, Ontario facility. This position is site‑based, with work hours adhering to a designated pattern of 12‑hour shifts.Responsibilities:Lead day‑to‑day manufacturing activities for assigned project, ensuring adherence to SOPs, GMP, and safety protocols.Serve as the SME for cleanroom operations, troubleshooting process issues and providing technical guidance.Lead and mentor Manufacturing Associates, providing training and performance feedback.Support tech transfer operations through close collaboration with MSAT on equipment selection, room layouts, batch record development, staff requirements, scheduling and training.Client communications and interaction supporting tech transfer and batch production.In conjunction with MSAT and the training supervisor, develop and provide project specific process training.Support supervisors in project and staff scheduling.Coordinate with Supply Chain and Quality teams to ensure materials and documentation are in place for project execution.Support equipment commissioning, qualification, and validation activities.As project SME, participate in investigations of non‑conformance events and contribute to root cause analysis.Drive continuous improvement initiatives within the team.Ensure accurate and timely completion of batch records and documentation.Communicate project status and issues to the Manager/Supervisor and other stakeholders.Helps drive standards to ensure a successful work environment.Utilizes the SAP enterprise resource planning system to support manufacturing activities.Qualifications:Two‑year college diploma in a relevant field (e.g., biotechnology, life sciences).Minimum 4 years of GMP manufacturing experience, with at least 1 year in a lead or mentoring role.Minimum 2 years of upstream/cell culture experience.Preference for experience on large scale systems such as bioreactors.Demonstrated expertise in cleanroom operations and aseptic techniques.Strong English written and verbal communication skills to support effective communication.Able to lift or carry up to 20 pounds.Desired Characteristics:Technical proficiency and problem‑solving skills.Leadership and team development.Strong interpersonal skills and effective communicator.Integrity, resilience, and attention to detail.Ability to work collaboratively and independently.Commitment to continuous improvement.High‑energy.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. #J-18808-Ljbffr