Stability Program Coordinator

Stability Program Coordinator

The Stability Program Coordinator assesses, improves, and oversees stability programs for plasmid and cell bank operations across multiple sites. This role focuses on identifying and closing documentation, process, and compliance gaps, developing and implementing robust stability strategies, and ensuring alignment with regulatory expectations and site quality requirements. The coordinator serves as a central point of contact for stability documentation and program coordination, partnering closely with cross-functional teams to bring all stability programs and supporting systems into a compliant and sustainable state within the first 6–12 months.

• Assess existing stability programs and identify gaps in documentation, processes, and compliance.
• Support the development and implementation of production cell bank stability programs.
• Review audit observations and establish detailed plans to ensure corrective actions are implemented, monitored, and maintained.
• Create, revise, and maintain stability protocols, reports, trending programs, technical documentation, and risk assessments.
• Manage stability-related records in electronic documentation systems and LIMS platforms.
• Conduct data integrity reviews and documentation checks to ensure accuracy, completeness, and compliance with quality standards.
• Support plasmid and cell bank stability programs across multiple sites, ensuring consistency and harmonization of practices.
• Partner closely with QC, Manufacturing, MSAT, and Quality stakeholders to ensure stability requirements are understood and met.
• Serve as the primary point of contact for stability documentation and program coordination activities.
• Work within existing quality frameworks while ensuring compliance with applicable regulatory expectations and site requirements.
• Drive efforts to bring all stability programs, documentation, and supporting systems into a compliant and sustainable state within 6–12 months.
• Support stability testing, trending, and risk assessment activities to inform program improvements and decision-making.
• Contribute to audit remediation efforts by updating documentation, processes, and systems related to stability programs.
• Coordinate with site teams to align cell therapy, gene therapy, and cell banking stability activities with overall quality and manufacturing strategies.

• Minimum 5 years of experience in stability programs, including design, execution, and oversight.
• Minimum 5 years of experience working within GMP quality systems and quality frameworks.
• Minimum 5 years of experience in GMP manufacturing environments, preferably in cell therapy or gene therapy settings.
• Minimum 5 years of experience preparing and maintaining technical documentation, including protocols, reports, and risk assessments.
• Hands-on experience supporting stability protocols, including setup, monitoring, and documentation.
• Experience supporting trending programs and interpreting stability data trends.
• Experience supporting risk assessments related to stability programs and quality systems.
• Experience supporting technical reports and documentation for regulatory and audit purposes.
• Proficiency with LIMS platforms for managing and tracking stability-related data and samples.
• Experience with electronic documentation systems for managing quality and stability records.
• Experience with GMP quality systems and stability testing processes.
• Experience in quality control, stability, cell banking, and gene therapy environments.

• Bachelor's degree in Biology, Microbiology, Biochemistry, Biotechnology, Chemistry, or a related scientific discipline.
• Experience in cell therapy operations and associated stability requirements.
• Experience with cell banking or production cell bank stability programs.
• Experience supporting audit remediation efforts, particularly related to stability and quality documentation.
• Experience working in QC, Stability, MSAT, or Quality organizations.
• Ability to collaborate effectively with cross-functional teams in a fast-paced environment.
• Strong attention to detail and commitment to data integrity and documentation accuracy.
• Excellent organizational and communication skills to manage multiple stability programs across sites.

This role operates in a hybrid work model, with approximately three days per week onsite at a Massachusetts cell therapy site and two days remote. Primary support is focused on the Massachusetts cell therapy…