Job Title: Manufacturing Cell Processing Team Lead
Job Description
The Manufacturing Cell Processing Team Lead serves as a key technical resource within the manufacturing team, providing on-the-floor leadership and support for daily cell processing operations in a cGMP-regulated cleanroom environment. This role guides manufacturing staff in the execution of complex cell processing activities, ensures adherence to cGMP, aseptic and cleanroom practices, and assists the supervisor with coordination of production activities. The Team Lead plays a central role in maintaining operational consistency, supporting training and development of team members, and contributing to continuous improvement initiatives that enable the delivery of an innovative, first-in-class cell therapy.
Responsibilities
Provide on-the-floor leadership and technical guidance during cell processing operations to support safe, compliant, and efficient execution of production activities.
Serve as a technical guide for cell processing operations, including cell culture, cell expansion, harvesting, formulation, and cryopreservation steps.
Coordinate daily manufacturing activities in alignment with the production schedule and operational priorities, ensuring resources and tasks are organized effectively.
Assist in task coordination and workflow organization during manufacturing operations to support timely and efficient execution of batch activities.
Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP, aseptic processing requirements, and established SOPs.
Support troubleshooting of process or equipment issues, identify potential root causes, and escalate concerns to the Manufacturing Supervisor when appropriate.
Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy, completeness, and adherence to Good Documentation Practices (GDP).
Support the development, training, and mentoring of manufacturing personnel on cell processing techniques, SOPs, aseptic techniques, and cleanroom practices.
Contribute to deviation investigations and CAPA activities by providing technical input, operational insight, and recommendations for process improvements.
Assist with implementation, revision, and continuous improvement of manufacturing procedures, batch records, and related documentation as processes evolve.
Participate in daily tier meetings and communicate operational updates, risks, and resource needs to the Supervisor and broader team.
Maintain compliance with safety procedures, cGMP regulations, internal quality standards, and cleanroom gowning and behavior requirements.
Support audit readiness activities and participate in internal and external inspections as needed.
Perform other duties as assigned to support manufacturing operations and the successful delivery of cell therapy products.
Essential Skills
Strong hands-on experience with aseptic technique and aseptic operations in a regulated environment.
Practical experience working in cleanroom environments, including sterile processing and environmental monitoring.
Proficiency in cell culture and cell biology techniques relevant to cell processing and manufacturing.
Working knowledge of molecular biology methods applicable to cell-based products.
Demonstrated experience with cGMP manufacturing practices and Good Documentation Practices (GDP).
Ability to perform and document batch record activities accurately and consistently.
Experience with SOP-driven operations, including adherence to and execution of written procedures.
Capability to troubleshoot process and equipment issues during manufacturing activities.
Experience in supervision or training of laboratory or manufacturing personnel, including coaching on techniques and procedures.
Familiarity with decontamination procedures and sterile handling in a cleanroom environment.
Minimum of approximately 5+ years of relevant experience in biotechnology manufacturing or a closely related field.
Education including an AS or BS in Biotechnology, Biology, Chemistry, or an equivalent science-related discipline, or a High School Diploma or equivalent with relevant experience.
Additional Skills & Qualifications
Preferred AS/BS degree in a science-related discipline such as Biotechnology, Biology, or Chemistry.
Prior experience as a supervisor, lead, or trainer in a laboratory or manufacturing setting is highly preferred.
Experience with medical device or cell therapy manufacturing processes is beneficial.
Familiarity with immunoassay techniques and DNA extraction methods is advantageous.
Experience with environmental monitoring in controlled or classified spaces is a plus.
Strong understanding of cleanroom behavior, sterile gowning requirements, and contamination control strategies.
Ability to contribute to deviation investigations and CAPA implementation through sound technical judgment.
Comfort working with and updating SOPs, batch records, and other controlled documents.
Strong communication skills to effectively guide team members and provide clear operational updates.
Demonstrated commitment to quality, safety, and continuous improvement in a regulated manufacturing environment.
Work Environment
This role operates in both laboratory and office settings, with a primary focus on work performed in classified cleanroom environments. The manufacturing facility includes ISO-equivalent 10,000 and 100,000 cleanroom spaces where sterile processing, cell culture, and other critical operations take place. Team members must successfully complete and maintain sterile gowning certification and consistently follow cleanroom gowning, behavior, and contamination control requirements. The position involves working with cGMP-regulated cell therapy manufacturing processes, including aseptic operations, environmental monitoring, and use of specialized equipment for cell culture, formulation, and cryopreservation. Standard working hours are supplemented by regular overtime, with an expectation of approximately 10 hours of overtime per week and rotating Saturday shifts approximately every six weeks. The environment emphasizes collaboration, technical excellence, and a shared mission to advance a first-in-class cell therapy.
Job Type & Location
This is a Permanent position based out of Winston Salem, NC.
Pay and Benefits
The pay range for this position is $70000.00 - $90000.00/yr.
Will provide details as needed.
Workplace Type
This is a fully onsite position in Winston Salem,NC.
Application Deadline
This position is anticipated to close on May 14, 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.
