Role Summary:
OmniaBio is seeking a detail-oriented and agile Batch Release Specialist to join our Project Management group. This role is pivotal in coordinating the batch release process for cell and gene therapy products with short shelf lives. The specialist will serve as a key communication link between Quality, Operations, and Project Execution teams, ensuring timely and compliant batch disposition. The position requires real-time tracking of production and testing milestones, proactive documentation management, and close coordination with clinical and commercial stakeholders. This role also includes project management responsibilities to track all batch-related activities from initial client request through to final release and delivery, ensuring alignment with projected timelines and patient schedules. The position will be located on site in Hamilton, ON.
Responsibilities:
Track, manage, and drive end-to-end batch lifecycle from client request to material release and delivery.
Understand all batch release data requirements includes EM data, Cal/PM data, facility data, process data, training, change control, deviation, material release, Logbooks, EMPQ, APS, Method Qualification/Validation, Specifications. QC data, C of A, batch records and C of C and plan stakeholder engagement for timely closure.
Gather, organize, and present batch release data to the Manufacturing Quality Manager for final approval.
Ensure day-to-day QMS (Quality Management System) requirements are met across operations.
Utilize current project management methodologies to trend and track progress of the batch release process, ensuring transparency and timely decision-making.
Review and approve SOP, batch related documents.
Coordinate batch release activities across manufacturing, quality, and logistics teams. Maintain real-time tracking of production and testing milestones to ensure timely release.
Facilitate documentation reviews, deviation resolutions, and QA approvals to prevent delays.
Communicate closely with stakeholders/client to align batch delivery windows with patient schedules.
Implement risk mitigation strategies for temperature excursions, transport delays, and quality holds.
Support material release, CCR/DR processes, and general logbook management.
Maintain compliance with regulatory expectations and internal SOPs.
Perform other duties and responsibilities as assigned.
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or a related field.
5+ years of experience in GMP manufacturing, quality assurance, or batch release coordination.
Strong understanding of cell and gene therapy manufacturing processes.
Experience with QMS systems and batch documentation practices.
Familiarity with regulatory requirements for clinical and commercial product release.
Proficiency in data tracking and project coordination tools.
Demonstrated experience in project management, especially in coordinating cross-functional teams and timelines.
Desired Characteristics:
Exceptional attention to detail and organizational skills.
Strong communication and interpersonal abilities.
Ability to work under tight timelines and manage multiple priorities.
Proactive problem-solving and risk management mindset.
Collaborative team player with a commitment to quality and compliance.
Comfortable working in a fast-paced, dynamic environment.
