QC Stability Manager

Job Description

Job Description

Job Title: QC Stability Manager Job Description

The QC Stability Manager is responsible for leading and maintaining stability programs that support clinical and commercial cell and gene therapy products. This role serves as the stability subject matter expert and primary point of contact for all stability-related activities across internal teams, contract manufacturing organizations, and contract testing laboratories. The position plays a critical role in ensuring robust stability strategies, compliant execution of studies, and high-quality data to support shelf-life, storage conditions, and regulatory submissions for advanced therapies.

• Manage and oversee stability programs and studies that support clinical and commercial cell therapy products, ensuring alignment with quality and regulatory expectations.
• Author, review, and approve stability protocols, study plans, reports, and all related documentation to ensure scientific soundness and regulatory compliance.
• Coordinate the stability program end-to-end, including long-term, accelerated, in-use, freeze-thaw, transport, and comparability studies, driving timely execution and adherence to approved protocols.
• Review, analyze, and trend stability data to support shelf-life assignments, expiry dating, storage conditions, and product quality decisions.
• Oversee stability activities conducted by contract manufacturing organizations, external suppliers, and contract testing laboratories, ensuring compliance with quality standards and regulatory requirements.
• Monitor overall stability program performance, maintain study tracking systems, and proactively communicate study status, data trends, and risks to key stakeholders.
• Support batch disposition activities by reviewing quality control data and providing stability-related input to product release decisions.
• Lead or support investigations related to stability failures, out-of-specification (OOS) and out-of-trend (OOT) results, laboratory deviations, and product quality issues, ensuring thorough root cause analysis and effective corrective actions.
• Author and review stability-related content for regulatory documentation and support regulatory inspections, audits, and submissions.
• Collaborate closely with internal cross-functional groups, including CMC and Quality, to align stability strategies with overall product development and commercialization plans.
• Engage with external partners, including CDMOs/CMOs and contract laboratories, to coordinate stability activities, resolve issues, and maintain strong communication channels.

• Bachelors degree with 7+ years or Masters degree with 5+ years of experience in biotechnology, pharmaceutical, biologics, cell and gene therapy, or related industries.
• At least 5+ years of experience managing or supporting GMP stability programs for clinical and/or commercial products.
• Direct experience performing or overseeing release assays specific to cell therapies and supporting product quality assessments within a GMP environment.
• Demonstrated experience managing stability activities performed by CMOs, contract testing laboratories, and external suppliers.
• Hands-on experience with stability study design, execution, data analysis, trending, and reporting.
• Strong knowledge of GMP regulations, ICH stability guidelines, and applicable global regulatory requirements related to stability.
• Proficiency in working with stability programs and stability assays, including handling OOS and OOT results.
• Ability to lead and contribute to investigations related to stability failures, OOS, OOT, and laboratory deviations.
• Strong analytical skills and attention to detail when reviewing and interpreting stability data.

• Experience supporting regulatory submissions such as IND, CTA, BLA, NDA, MAA, or equivalent.
• Experience with electronic Quality Management Systems (eQMS) and electronic laboratory notebooks.
• Experience supporting batch disposition and QC activities for cell and gene therapy products.
• Background in startup or fast-paced biotechnology environments, with the ability to adapt to evolving priorities.
• Experience applying statistical tools to evaluate stability trends and support shelf-life determinations.
• Strong communication skills, with the ability to clearly present data trends and study outcomes to internal and external stakeholders.
• Ability to collaborate effectively with CMC, Quality, and external partners to align stability strategies with product development goals.
• Understanding of the role of Quality and Compliance in successful regulatory filings for advanced therapies.

This is a first-shift hybrid role with an expectation of one day onsite per week, providing a balance of remote and on-site work. A laptop will be provided to support daily responsibilities and collaboration with internal teams and external partners. The organization is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies for autoimmune diseases, where Quality and Compliance play a critical role in achieving successful regulatory filings. The environment is fast-paced and growth-oriented, offering the opportunity to contribute meaningfully to the advancement and commercialization of innovative therapies. While on contract, you will receive accrued paid time off, six paid holidays, health, dental, and vision benefits, as well as access to a 401(k) plan.

This is a Contract to Hire position based out of Philadelphia, PA.

The pay range for this position is $57.69 - $62.50/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 Contract to Hire position based out of Philadelphia, PA.

This position is anticipated to close on Oct 26, 2026.

This is a hybrid position in Philadelphia,PA.

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.