Real-Time Batch Release Lead for Cell Therapy

OmniaBio; Hamilton; On-site; CAD 80,000 - 100,000; Full time

Job summary

A biotechnology firm in Hamilton, ON is seeking a detail-oriented Batch Release Specialist to coordinate the batch release process for cell and gene therapy products. You will manage the end-to-end lifecycle from client request to release, ensuring compliance with quality management systems and regulatory standards. Ideal candidates will have a Bachelor's degree in Life Sciences, over 5 years of relevant experience, and strong project management skills. The role requires collaboration with internal teams and stakeholders to ensure timely delivery aligned with patient schedules.

Qualifications

• 5+ years of experience in GMP manufacturing, quality assurance, or batch release coordination.
• Strong understanding of cell and gene therapy manufacturing processes.
• Experience with batch documentation practices and regulatory requirements.

Responsibilities

• Track and manage end-to-end batch lifecycle from client request to release.
• Gather and present batch release data for final approval.
• Coordinate batch release activities across manufacturing, quality, and logistics teams.

Skills

Attention to detail

Project management

Communication

Problem-solving

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

QMS systems

Data tracking tools

Job description

A biotechnology firm in Hamilton, ON is seeking a detail-oriented Batch Release Specialist to coordinate the batch release process for cell and gene therapy products. You will manage the end-to-end lifecycle from client request to release, ensuring compliance with quality management systems and regulatory standards. Ideal candidates will have a Bachelor's degree in Life Sciences, over 5 years of relevant experience, and strong project management skills. The role requires collaboration with internal teams and stakeholders to ensure timely delivery aligned with patient schedules.