Stability Program Lead — Hybrid GMP & Cell Therapy

Actalent; Westborough (MA); Hybrid; USD 48,000 - 80,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) Retirement Plan

Job summary

Actalent is seeking a Stability Program Coordinator in Westborough, MA to assess, improve, and oversee 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.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Biotechnology, Chemistry or related field is required.
• Minimum 5 years of experience in stability programs, GMP quality systems, and GMP manufacturing environments.
• Experience creating and maintaining technical documentation, protocols, reports, and risk assessments.

Responsibilities

• Assess existing stability programs and identify gaps in documentation, processes, and compliance.
• Support development and implementation of production cell bank stability programs.
• Review audit observations and develop detailed corrective action plans.
• Create, revise, and maintain stability protocols, reports, and risk assessments.
• Manage stability-related records in electronic documentation systems and LIMS platforms.
• Conduct data integrity reviews and documentation checks for accuracy and compliance.
• Support stability programs across multiple sites ensuring consistency and harmonization.
• Collaborate with QC, Manufacturing, MSAT, and Quality to ensure stability requirements are understood and met.
• Serve as primary contact for stability documentation and coordination activities.
• Ensure compliance with regulatory expectations and site requirements.
• Drive projects to bring stability programs into compliant state within 6-12 months.
• Support stability testing, trending, and risk assessment activities.

Skills

Stability program management

GMP quality systems

GMP manufacturing environments

Technical documentation

LIMS proficiency

Electronic documentation systems

Data integrity reviews

Education

Bachelor's degree in Biology / Microbiology / Biochemistry / Biotechnology / Chemistry

Tools

LIMS software

Electronic Documentation Systems

Job description

Actalent is seeking a Stability Program Coordinator in Westborough, MA to assess, improve, and oversee 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.