Job Title: Manufacturing Cell Processing Specialist III (GMP Experience Required)
Job Description
The Manufacturing Cell Processing Specialist III plays a key role in advanced cell therapy manufacturing operations, with a primary focus on cell processing activities and strict adherence to cGMP guidelines. This position operates and maintains specialized production equipment, performs final product freezing and storage, and drives continuous improvement across manufacturing processes. The specialist mentors team members, leads investigations into deviations and CAPAs, and ensures consistently high levels of quality, compliance, and safety within a cleanroom environment.
Responsibilities
Lead and oversee day-to-day 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 on proper execution.
Set up, operate, monitor, and troubleshoot production equipment such as controlled rate freezers, orbital shakers, and related systems to ensure optimal performance and reliability.
Perform final freezing and storage of cell therapy products in liquid nitrogen (LN2), following established procedures to maintain product quality and integrity.
Revise, update, and maintain SOPs, batch records, and manufacturing forms to ensure they remain current, accurate, and aligned with GMP requirements.
Ensure adherence to Good Documentation Practices by accurately completing GMP documentation, including batch records, logbooks, and forms.
Lead routine cycle counts and manage accurate inventory tracking and control of materials, components, and supplies used in manufacturing.
Execute transactions within the ERP system, including material requisitions, inventory movements, and production tracking, to maintain real-time data integrity.
Lead or actively participate in investigations into deviations, incidents, and nonconformances, compiling data and documentation to support root cause analysis and Corrective and Preventive Action (CAPA) activities.
Drive continuous process improvement initiatives by identifying opportunities to optimize workflows, enhance efficiency, and strengthen quality and compliance.
Conduct aseptic manufacturing processes in a cleanroom environment, consistently applying aseptic technique and sterile processing practices to prevent contamination.
Perform environmental monitoring, decontamination, and cleanroom maintenance activities in alignment with established procedures and regulatory expectations.
Troubleshoot technical and process-related issues in cell processing, equipment operation, and documentation, escalating and resolving problems in a timely manner.
Ensure all manufacturing activities comply with applicable safety policies, rules, and regulations, and actively promote a safe working environment.
Collaborate cross-functionally with quality, engineering, and other operational teams to support technology transfer, process validation, and ongoing manufacturing readiness.
Mentor and support less experienced staff by sharing technical expertise in cell culture, aseptic operations, and GMP manufacturing practices.
Essential Skills
Preferred minimum of 2 years of relevant experience in cell processing, biotechnology manufacturing, or a closely related field.
1+ years of proven experience working in a cGMP-regulated manufacturing environment.
Hands-on experience with aseptic technique, aseptic operations, and sterile processing in a cleanroom setting.
Practical experience in cell culture, cell biology, and related laboratory methods.
Working knowledge of molecular biology concepts as applied to cell-based manufacturing processes.
Demonstrated proficiency with controlled rate freezers, orbital shakers, and other cell processing production equipment, including basic troubleshooting.
Strong understanding of cGMP principles, Good Documentation Practices, and batch record completion.
Experience with SOP execution, revision, and adherence in a regulated environment.
Ability to conduct and document environmental monitoring and decontamination activities in a cleanroom.
Proficiency in executing and reviewing batch records and associated GMP documentation.
Ability to exercise independent judgment, take ownership of tasks, and lead teams within manufacturing operations.
Strong computer skills, including proficiency with Microsoft Office applications.
Experience working with ERP systems for material management, inventory control, and production tracking.
Advanced organizational, record-keeping, and time management skills with high attention to detail.
Additional Skills & Qualifications
AS or BS degree in Biotechnology, Biology, Chemistry, or a related scientific discipline is preferred.
A science-related discipline is strongly valued for understanding complex cell therapy processes.
Relevant industry experience may substitute for formal education where appropriate.
A high school diploma or equivalent may be considered with significant and directly relevant experience in cell processing or biotechnology manufacturing.
Experience in medical device or related regulated industries is beneficial.
Familiarity with laboratory operations, including equipment handling, decontamination procedures, and general lab safety.
Experience with environmental monitoring programs in cleanroom or controlled environments.
Strong troubleshooting skills for both process and equipment-related issues.
Ability to contribute to deviation investigations and CAPA development through data compilation and analysis.
Effective communication skills to collaborate across functions and to mentor and train colleagues.
Work Environment
This role operates in both laboratory and office settings, with a significant portion of time spent in a controlled cleanroom environment. The cleanroom includes ISO-equivalent 10k and 100k areas, requiring strict adherence to sterile gowning procedures and the ability to maintain gowning certification. Work involves aseptic manufacturing, sterile processing, environmental monitoring, and handling of cell therapy products, including final freezing and storage in liquid nitrogen. Standard work schedule is Monday through Friday, with assignment to either a 7:00 AM-3:00 PM shift or a 10:00 AM-7:00 PM shift based on experience and operational needs. The environment is highly regulated, safety-focused, and quality-driven, utilizing specialized production equipment, ERP systems, and standard office productivity tools to support advanced cell therapy manufacturing.
Job Type & Location
This is a Contract to Hire position based out of Winston Salem, NC.
Pay and Benefits
The pay range for this position is $32.00 - $38.00/hr.
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 May 27, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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.
