Stability Program Coordinator

Job Description

Job Description

Job Title: Stability Program Coordinator

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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 facility, with secondary support provided to an additional site as needed. The work environment is fast-paced and highly collaborative, with frequent interaction with QC, Stability, Manufacturing, MSAT, and Quality stakeholders. The position follows a Monday through Friday, first-shift schedule within a 40-hour work week, in a setting dedicated to bringing critical stability programs into full compliance and maintaining high quality standards.

This is a Contract position based out of Westborough, MA.

The pay range for this position is $35.00 - $58.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Westborough,MA.

This position is anticipated to close on Oct 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.