Manufacturing Cell Processing Specialist I

Job Title: Manufacturing Cell Processing Specialist I

Job Description

The Manufacturing Cell Processing Specialist I supports advanced cell therapy manufacturing operations by executing and overseeing cell processing activities in a cGMP-regulated environment. This role focuses on operating and maintaining specialized production equipment, performing final product freezing and storage, and ensuring strict adherence to Standard Operating Procedures and Good Documentation Practices. The Specialist mentors team members, leads investigations into deviations and CAPA activities, and drives continuous process improvements to maintain high standards of quality, safety, and compliance.

Responsibilities

• Lead and oversee cell processing activities while ensuring full compliance with cGMP guidelines and internal manufacturing standards.
• Read, interpret, and implement Standard Operating Procedures (SOPs) for all assigned tasks, and provide clear guidance and training to team members.
• Set up, operate, and troubleshoot production equipment such as controlled rate freezers and orbital shakers, ensuring optimal performance and coordinating preventive maintenance.
• Perform final freezing and storage of cell therapy products in liquid nitrogen (LN2), strictly following procedures to maintain product quality and integrity.
• Revise, update, and enforce adherence to SOPs, batch records, and manufacturing forms to ensure ongoing GMP compliance.
• Lead routine cycle counts and maintain accurate inventory tracking and control of materials and supplies.
• Execute transactions within the ERP system, including material requisitions, production tracking, and related documentation.
• Ensure the accuracy and completeness of GMP documentation, including batch records, logbooks, and forms, in alignment with Good Documentation Practices.
• Lead or support investigations into deviations and participate in Corrective and Preventive Action (CAPA) activities, compiling data and documentation as required.
• Drive continuous process improvement initiatives, including incident investigations and deviation resolution, to enhance efficiency and product quality.
• Promote and maintain a safe working environment by ensuring all activities comply with safety policies, rules, and regulations.
• Conduct aseptic manufacturing processes in a cleanroom environment, consistently applying sterile techniques and meeting regulatory standards.
• Collaborate with cross-functional teams to support late clinical-stage cell therapy manufacturing and contribute to the advancement of novel therapies for chronic kidney disease.

Essential Skills

• 1–3 years of relevant experience in cell processing, biotechnology manufacturing, or a related field.
• 1–3 years of proven experience in a cGMP-regulated environment.
• Demonstrated experience with aseptic operations and aseptic techniques in a cleanroom setting.
• Hands-on experience with cell culture, cell biology, or related laboratory procedures.
• Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices.
• Ability to set up, operate, and troubleshoot production equipment such as controlled rate freezers and orbital shakers.
• Proficiency with ERP systems for material requisitions and production tracking.
• Strong computer skills, including Microsoft Office applications.
• Ability to exercise independent judgment and make sound decisions in a regulated manufacturing environment.
• Demonstrated ability to lead and mentor team members while ensuring compliance with cGMP requirements.
• Strong organizational, record-keeping, and time management skills.
• Ability to perform and document environmental monitoring, decontamination, and sterile processing activities.
• Experience completing and reviewing batch records, logbooks, and related GMP documentation.

Additional Skills & Qualifications

• AS or BS in Biotechnology, Biology, Chemistry, or a related science discipline is preferred.
• A science-related discipline is strongly preferred; relevant experience may substitute for formal education.
• A high school diploma or equivalent may be considered with significant relevant experience in cell processing or biotechnology manufacturing.
• Experience in cleanroom operations at varying classifications (e.g., 10k and 100k cleanrooms).
• Familiarity with molecular biology techniques is beneficial.
• Experience in medical device or related regulated industries is an advantage.
• Experience in sterile processing, environmental monitoring, and decontamination procedures.
• Experience working with SOPs, including authoring, revising, and implementing controlled documents.
• Troubleshooting skills for laboratory and manufacturing equipment.
• Interest in or exposure to cell therapy manufacturing and therapies targeting chronic kidney disease.

Work Environment

The role is based in both laboratory and office settings, with a significant portion of work performed in classified cleanroom environments (approximately 10k and 100k cleanrooms). The Specialist conducts aseptic manufacturing and sterile processing activities, including environmental monitoring, decontamination, and cell processing operations. The position requires sterile gowning and maintaining ongoing certification for sterile gowning to ensure compliance with cleanroom and regulatory standards. Work is performed using specialized equipment such as controlled rate freezers, orbital shakers, and liquid nitrogen storage systems, alongside standard laboratory and computer-based tools, including ERP systems and Microsoft Office. The work schedule is Monday through Friday, with assignment to either a 7:00 a.m. to 3:00 p.m. shift or a 10:00 a.m. to 7:00 p.m. shift, depending on experience and operational needs.

This is a Permanent position based out of Winston Salem, NC.

The pay range for this position is $54000.00 - $58000.00/yr.

Will provide benefits as needed.

This is a fully onsite position in Winston Salem,NC.

This position is anticipated to close on Jul 16, 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.

Salary : $54,000 - $58,000