Job Description
The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role provides on-the-floor guidance to manufacturing staff, supports execution of cell processing activities, and assists the Shift Manufacturing Supervisor with coordination of production activities. The Team Lead functions as a leader in manufacturing processes, promotes adherence to cGMP and aseptic techniques, and contributes to operational consistency, training, and continuous improvement.
This position is located onsite in Winston Salem, NC.
Essential Duties & Responsibilities:
- Provide on-the-floor leadership and technical guidance during cell processing operations, supporting the manufacturing team in executing production activities safely and
- Serve as a technical guide for cell processing operations, including cell culture, expansion, harvesting, formulation, and cryopreservation.
- Support coordination of daily manufacturing activities to ensure alignment with the production schedule and operational priorities.
- Assist in task coordination and workflow organization during manufacturing operations to support efficient execution of batch activities.
- Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP and aseptic processing requirements.
- Support troubleshooting of process or equipment issues and escalate concerns to the Manufacturing Supervisor when appropriate.
- Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy and adherence to Good Documentation Practices (GDP).
- Support the development and training of manufacturing personnel on cell processing techniques, SOPs, and cleanroom practices.
- Contribute to deviation investigations, CAPA activities, and process improvements by providing technical input and operational knowledge.
- Assist with implementation or revision of manufacturing procedures, batch records, and documentation as processes evolve.
- Participate in daily tier meetings and communicate operational updates, risks, or resource needs to the Supervisor.
- Maintain compliance with safety procedures, cGMP regulations, and internal quality
- Support audit readiness and participate in inspections as
- Perform other duties as assigned to support manufacturing
Minimum Qualifications:
- Education/Training AS/BS in Biotechnology, Biology, Chemistry, or equivalent; preferred area of study in a Science-related discipline. High School Diploma or Equivalent with relevant experience may be considered.
- Experience Preferred minimum 4 years of relevant experience in biotechnology manufacturing or a related field.
- Skills/Abilities Proficiency in biological processing techniques such as cell culture, ultra-filtration, and column Advanced knowledge of cGMP facilities and requirements. Strong organizational skills with the ability to manage multiple projects and meet deadlines. Critical thinking ability and judgment to make appropriate decisions within defined procedures.
- Other Excellent eye/hand coordination, effective written and oral communication skills, team-oriented with a strong work ethic.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
