Stability Program Lead – Cell & Gene Therapy

Actalent; United States; Hybrid; USD 79,000 - 86,000; Full time

Benefits offered by this job

Health, dental, and vision benefits

401(k) Retirement Plan

Paid time off

Job summary

Actalent is seeking a QC Stability Manager to lead stability programs for clinical and commercial cell therapy products. You will act as the stability SME, coordinating studies across internal teams, CMOs, and contract labs to ensure compliant execution and high-quality data for shelf-life determinations.

The role requires overseeing protocols, data analysis, and investigations into OOS/OOT results, with a focus on regulatory-ready documentation and cross-functional collaboration within a hybrid

Qualifications

• Bachelor's degree in biotechnology, masters preferred, with relevant experience in GMP environments.
• Experience leading stability programs for cell therapy products.
• Knowledge of GMP regulations, ICH stability guidelines, and global regulatory requirements.

Responsibilities

• Manage and oversee stability programs for clinical and commercial cell therapy products.
• Author, review, and approve stability protocols, study plans and reports.
• Coordinate end-to-end stability studies (long-term, accelerated, in-use, freeze-thaw, transport).
• Review and trend stability data to support shelf-life and storage conditions.
• Oversee stability activities by CMOs, testing labs, and external suppliers.

Skills

GMP stability

Cell therapy

Quality systems

Regulatory compliance

Data analysis

Investigations

Vendor management

Problem solving

Documentation

Education

Bachelor's degree in biotech

Master's degree in related field

Tools

eQMS

ELN

Job description

Actalent is seeking a QC Stability Manager to lead stability programs for clinical and commercial cell therapy products. You will act as the stability SME, coordinating studies across internal teams, CMOs, and contract labs to ensure compliant execution and high-quality data for shelf-life determinations.

The role requires overseeing protocols, data analysis, and investigations into OOS/OOT results, with a focus on regulatory-ready documentation and cross-functional collaboration within a hybrid