Sr Materials Quality & Compliance Scientist About the Role We are seeking an experienced scientist to support the development and commercialization of advanced cell therapy products by leading raw material qualification, supplier quality, and container closure strategy initiatives. This individual will play a key role in ensuring materials, suppliers, and packaging systems meet regulatory and quality expectations while supporting manufacturing readiness and commercial launch activities. This position offers the opportunity to work cross-functionally with Quality, Manufacturing, Regulatory, Supply Chain, and Technical Development teams in a fast-paced, innovative environment. Key Responsibilities Develop and maintain risk-based raw material classification, qualification, and lifecycle management programs. Author and maintain material specifications for GMP-critical, ancillary, and non-critical materials. Support supplier qualification activities, quality agreements, supplier performance monitoring, and ongoing supplier management. Evaluate supplier change notifications, deviations, CAPAs, and quality-related documentation. Lead risk assessments and traceability programs for raw materials and product-contact components. Improve inspection readiness and support regulatory audit preparation activities. Design incoming material testing strategies, sampling plans, and material release processes. Establish testing approaches for material identity, quality verification, and supplier Certificate of Analysis (CoA) qualification. Support implementation and optimization of material management workflows within quality and manufacturing systems. Manage material disposition programs, including quarantine, hold, release, retest, and inventory controls. Develop supplier scorecards and performance metrics to drive continuous improvement. Lead extractables and leachables (E&L) assessments for single-use systems, manufacturing consumables, and product-contact materials. Support toxicological evaluations and patient safety assessments related to material selection and product quality. Develop and execute container closure integrity strategies to support product stability and regulatory compliance. Support the qualification and performance evaluation of cryopreserved container closure systems used in cell therapy manufacturing. Partner with cross-functional teams to support commercial readiness and long-term manufacturing scalability. Required Qualifications Bachelor's degree in Life Sciences, Biology, Biochemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline. 10+ years of experience supporting biologics, cell therapy, or gene therapy product development and manufacturing. Strong knowledge of GMP manufacturing environments and material qualification programs. Experience with supplier quality management, raw material controls, and quality systems. Hands-on experience supporting commercial launch readiness and manufacturing scale-up activities. Experience supporting sterile manufacturing operations and regulated pharmaceutical environments. Strong understanding of material risk management, quality compliance, and inspection readiness. Excellent communication, problem-solving, and cross-functional collaboration skills. Preferred Qualifications Experience supporting autologous cell therapy products. Experience in organizations transitioning from clinical-stage development to commercial manufacturing. Experience with cryopreserved product packaging and container closure systems. Direct experience supporting internal cGMP manufacturing operations. Knowledge of extractables and leachables strategies and material compatibility assessments. Preferred Skills Raw Material Qualification & Control Cell Therapy Manufacturing Supplier Quality Management Sterile Manufacturing GMP Compliance Extractables & Leachables (E&L)

Commercial Launch Readiness Quality Systems & Risk Management Experience Level:

Mid- Sr Level If interested, please reach out directly to Lindsee Allienello @ actalentservices.com. Job Type & Location This is a Contract position based out of Winston-Salem, NC. Pay and Benefits The pay range for this position is $75.00 - $85.00/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) Workplace Type This is a fully onsite position in Winston-Salem,NC.

Application Deadline This position is anticipated to close on Sep 24, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

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

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.