Stability Programs Lead - Cell Therapy & GMP Compliance

Actalent; United States; Hybrid; USD 100,289,000 - 166,194,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Stability Program Coordinator for a contract role in Westborough, MA. You will oversee stability programs for plasmid and cell bank operations across sites, develop robust stability strategies, and partner with QC, Manufacturing, MSAT, and Quality to ensure regulatory alignment.

The role focuses on closing documentation gaps, maintaining stability records, and driving continuous improvements within 6–12 months.

Qualifications

• Minimum 5 years of experience in stability programs across GMP environments.
• Experience with stability protocols, reporting, and risk assessments.
• Experience in cell therapy or gene therapy stability programs is preferred.

Responsibilities

• Assess stability programs, identify gaps in documentation, processes and compliance.

Skills

Stability programs

GMP quality systems

Cell therapy stability

Documentation accuracy

LIMS proficiency

Data integrity

Cross-functional collaboration

Audit remediation

Regulatory compliance

Stability testing

Education

Bachelor's degree in Biology/related

Tools

LIMS platforms

Electronic documentation systems

Job description

Actalent is seeking a Stability Program Coordinator for a contract role in Westborough, MA. You will oversee stability programs for plasmid and cell bank operations across sites, develop robust stability strategies, and partner with QC, Manufacturing, MSAT, and Quality to ensure regulatory alignment.

The role focuses on closing documentation gaps, maintaining stability records, and driving continuous improvements within 6–12 months.