Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Manufacturing Cell Processing Team Lead

ProKidney

The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing team, troubleshooting issues, leading deviation and CAPA investigations, and mentoring staff. The Team Lead is a Subject Matter Expert (SME) in manufacturing processes, driving continuous improvement, ensuring high-quality GMP documentation, and promoting operational efficiency.

This is an onsite position based in Winston-Salem, NC. The standard schedule is Sunday through Thursday, 7:00 a.m. to 3:30 p.m. Additional overtime may be required based on business needs. Flexibility to adjust work hours and schedules as needed to support operational priorities is preferred.


  • Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.
    • Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.
    • Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members.
    • Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions.
    • Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines.
    • Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs.
    • Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed.
    • Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations.
    • Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs.
    • Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP).
    • Support the maintenance of the cleanroom environment, ensuring cleanliness and compliance with alert-level limits.
    • Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.
    • Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary.
    • Lead and direct the work of others, with a wide degree of creativity and latitude expected. May provide consultation on projects and serve as a high-level contributor/specialist.

  • Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Secondary Responsibilities:


  • Participate in internal and external audits as required.
    • Compile and analyze data, prepare reports, and make recommendations for process improvements.
    • Perform routine logbook reviews and data tracking.
    • Provide support for process development activities as needed.
    • Perform other duties as assigned to support manufacturing operations effectively.

Minimum Qualifications:


  • Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline preferred. High School Diploma or equivalent may be considered with significant relevant experience.
    Experience: Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 3-4 years of proven expertise in a cGMP-regulated environment.
    Skills/Abilities:
    • Thorough knowledge of various biological processing techniques, including cell culture, relevant to ProKidney's cell therapy process. • Advanced knowledge of cGMP facilities and requirements.
    • Proficiency in Microsoft applications, especially Word, Excel, etc.
    • Strong organizational skills and the ability to manage and prioritize multiple projects or assignments, meeting deadlines effectively.
    • Critical thinking and troubleshooting skills to handle unexpected events.
    • Ability to exercise judgment within defined procedures and practices to determine appropriate actions.
    Other: Good eye/hand coordination, effective written and oral communication, a team-oriented approach, and 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.
Vacancy posted 22 hours ago
Similar jobs that could be interesting for youBased on the Manufacturing Cell Processing Team Lead in Winston Salem, NC vacancy
  • The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing... 
    Suggested
    Visa sponsorship
    Work visa

    ProKidney

    Winston Salem, NC
    1 day ago
  •  ...responsible for all areas of production for a single shift and leads a Team of people assigned to perform work; direct people to produce...  ...or GED and 5 years supervisory experience in a corrugated manufacturing environment. Must be able to read a tape measure and math... 
    Suggested
    Shift work

    WestRock

    Winston Salem, NC
    3 days ago
  •  ...Quality Assurance Coordinator (ISO 9001) / QA Lead Support Textile Manufacturing | Quality Management | ISO 9001 |...  ...enjoys problem-solving, data analysis, process improvement, and working closely with production and quality teams to drive operational excellence. Key Responsibilities... 
    Suggested
    Work at office

    The Resource

    Winston Salem, NC
    22 hours ago
  •  ...America is seeking an experienced Director of Operations to lead manufacturing and operational performance at our High Point, North Carolina...  ...maintenance, and continuous improvement initiatives while aligning teams with company goals. #J-18808-Ljbffr Carpigiani North America
    Suggested

    Carpigiani North America

    Winston Salem, NC
    3 days ago
  •  ...experience, ZIEHL-ABEGG is the world leading fan and motor manufacturer. We are the proven leader in the fan...  ...the Pre-Assembly Production Manager, Team Leads, and Assembly Technicians to continuously...  ...plant goals, safety, continuous process improvements, employee morale and... 
    Suggested
    Temporary work
    Night shift
    Day shift

    ZIEHL-ABEGG Inc.

    Winston Salem, NC
    3 days ago
  •  ...seeking a Production Supervisor I - Shift 6am - 6pm to join our team! Who We Are We are jointly owned by Suntory and PepsiCo....  ...preferred. Three (3) to five (5) years of supervisory experience in manufacturing or related field required. Must also have OSHA and production... 
    Hourly pay
    Shift work

    Pepsi Bottling Ventures

    Winston Salem, NC
    2 days ago
  •  ...DescriptionPepsi Bottling Ventures is seeking a Production Line Lead to join our team!Who We AreWe are jointly owned by Suntory and PepsiCo....  ...years of related field experience working in a high-speed manufacturing environment preferred.Forklift experience preferred.... 

    Pepsi Bottling Ventures

    Winston Salem, NC
    3 days ago
  • $1,500 per month

     ...Job Description - Area Manager (Manufactured Housing) Location: Job Type...  ...speak up. Strive to be better. One team. These values shape how we work, lead, and collaborate, driving our decisions...  .... Manage the application process—issuing, reviewing, and approving... 
    Full time
    Temporary work
    For contractors
    Local area
    Flexible hours

    WGP PROPERTY MANAGEMENT LLC

    Winston Salem, NC
    9 days ago
  • Job TitleUnder immediate supervision, performs semi-skilled maintenance, oversees crew in the field and does related work as required.Examples of DutiesSupervises and participates in the work of unskilled and semi-skilled workers, Vehicle Operators and Sr. Equipment Operators...
    Temporary work
    Local area
    Immediate start
    Flexible hours

    GovernmentJobs.com

    Winston Salem, NC
    3 days ago
  •  ...seeking a dynamic leader to join our team as a Production Supervisor in...  ...Previous supervisor in a manufacturing Ability to work 2nd shift when needed...  ...Basic computer experience (word processing, Excel and PowerPoint) Responsibilities Lead safety, quality, productivity, and... 
    Hourly pay
    Contract work
    Shift work
    Night shift
    Afternoon shift

    Hood Container Corporation

    Winston Salem, NC
    1 day ago
  •  ...Overview Biomerics is a world-class manufacturer and innovative polymer...  ...to be part of our collective team, and there is no limit to the...  ...coordinates workflows, and implements process improvements to support...  ..., and to quality standards Lead, coach, and develop team... 
    Temporary work
    Work at office
    Afternoon shift

    BlueGreen Alliance

    Winston Salem, NC
    3 days ago
  • $75k

     ...this: You are part of a global team of problem-solvers whose...  ...and schedule the work of the manufacturing team to maximize efficiency and...  ...troubleshooting and technical details of process improvements. Oversee the...  ...conditions. Ability to lead, motivate, select, train and... 
    Hourly pay
    Shift work
    Afternoon shift

    Tekni-Plex Consumer Products

    Winston Salem, NC
    1 day ago
  •  ...Lead Master Automotive Technician Express Oil Change & Tire Engineers is the pre-eminent automotive maintenance provider in the nation with over 350 locations across 21 states, leading our industry through excellence, innovation, and growth. Don't let our name fool... 

    Express Oil Change & Tire Engineers

    Winston Salem, NC
    1 day ago
  • $70k

     ...responsible for making decisions and leading a team to ensure that established standards and...  ..., manage and schedule the work of the manufacturing team to maximize efficiency and meet...  ...troubleshooting and technical details of process improvements. Day-to-day management... 
    Weekly pay
    Shift work
    Afternoon shift

    TRC Talent Solutions

    Winston Salem, NC
    23 days ago
  • $23.75 - $28.88 per hour

     ...Corning is one of the world’s leading innovators in glass, ceramic, and...  ...quality work, values a strong team environment, and wants to build a career in manufacturing, this could be the opportunity...  ...in the application or interview process, perform essential job functions... 
    Hourly pay
    Shift work
    Night shift

    Corning Inc.

    Winston Salem, NC
    1 day ago
  • $28 - $32.5 per hour

     ...Join us at Corning, one of the world's leading innovators in glass, ceramic, and...  ...Purpose of Position: Facilitate cable manufacturing through process optimization and flow enhancements to...  ...meeting. All other duties as assigned by Team Leader. Education/Experience: High... 
    Hourly pay
    Work at office
    All shifts
    Shift work

    Corning

    Winston Salem, NC
    1 day ago
  • $14 per hour

     ...Manufacturing Associate Our client, a leading manufacturing organization, is seeking a dedicated Manufacturing Associate to join their dynamic team. As a Manufacturing Associate, you will be an integral part of the production process, supporting various departments... 
    Permanent employment
    Shift work
    Day shift

    Manpower

    Winston Salem, NC
    3 days ago
  • $120k - $160k

     ...work closely with members of the executive team to identify and assess new opportunities...  ...- Participate in projects that include leading multi-year planning activities, framing approaches...  ...and manage the business acquisition process - Take a leadership role in generating... 
    Full time
    Local area
    Flexible hours

    Contact Government Services, Llc

    Winston Salem, NC
    22 hours ago
  • $12 - $24.33 per hour

     ...Position Overview The Team Lead works closely with the Department Manager(s) or Store Manager to receive, price, and stock merchandise to meet the needs of the store's customers and drive sales and profits. Assist Team Members with completing the work within the... 
    Part time
    Flexible hours
    Afternoon shift

    Follett

    Winston Salem, NC
    1 day ago
  •  ...Team Leader Opportunity At CAVA At CAVA, we love what we do, and we try and make every day as fulfilling as the last. Our restaurants...  ...built on five core values: Generosity First, Always: We lead with kindness. Our best work happens when we act in service of others... 
    Local area
    Shift work

    CAVA - Christiana

    Winston Salem, NC
    3 days ago
  •  ...sets us apart is our people. We’re a passionate, purpose-driven team that’s as committed to each other as we are to our customers....  ...each position’s responsibilities and requirements. Store Team Lead Positions: Logistics Team Lead ( Operation Team Lead Store... 
    Full time

    Academy Sports + Outdoors

    Winston Salem, NC
    4 days ago
  • $106.4k - $146.3k

     ...Corning is one of the world’s leading innovators in glass, ceramic,...  ...evolved from being a manufacturer of optical fiber and cable, hardware...  ...to-day operational execution, team development, and continuous...  ...materials, and manufacturing processes Experience participating... 
    Full time
    Shift work

    Corning

    Winston Salem, NC
    6 days ago
  •  ...on LinkedIn. Petroleum Construction Lead Position Summary The Petroleum Construction...  ...to approved plans, specifications, manufacturer requirements, and company standards....  ...take ownership of the field installation process, lead a crew effectively, understand the... 
    For contractors
    For subcontractor
    Immediate start
    Relocation package
    Flexible hours
    Night shift

    OWL Services

    Winston Salem, NC
    14 days ago
  •  ...Walgreens is seeking a team member focused on inventory management and operations across both the front end and pharmacy. The role emphasizes accurate receiving, counting, pricing, and ensuring planogram compliance to maximize On-Shelf Availability. The position involves... 
    Flexible hours

    Walgreens

    Walkertown, NC
    2 days ago
  •  ...Team Lead, Petsense This position is responsible for assisting the Store Manager and Assistant Store Manager with the execution of operational...  ...Recovery of merchandise. Participate in mandatory freight process. Perform regular and promotional price change activities.... 
    Seasonal work
    Flexible hours
    Shift work
    Night shift
    Weekend work

    Tractor Supply

    Winston Salem, NC
    1 day ago
  • $22 - $30 per hour

     ...communicating goals and feedback training associates on processes and procedures providing direction and guidance to associates...  ...correcting ethical and compliance issues and problems Leads and participates in teams by using and sharing resources information and tools determining... 
    Hourly pay
    Minimum wage
    Full time
    Temporary work
    Part time
    Work at office

    Walmart

    Winston Salem, NC
    3 days ago
  • Walmart at Winston-Salem, NC is seeking a retail service associate to assist management in supervising front-end associates, train on processes, and guide member service approaches to resolve issues. You will help with recruiting, scheduling, coaching, and evaluating staff... 

    Walmart

    Winston Salem, NC
    3 days ago
  • $71k - $121k

     ....Role Overview: Supervises less complex teams of colleagues who perform similar production...  ...g., assembly, material forming/shaping, processing, treating, or packaging, etc.)....  ...relevant experience, including experience leading colleagues.Key Responsibilities - Monday... 
    Temporary work
    Work at office
    Local area
    Monday to Friday
    Shift work

    Greif

    Kernersville, NC
    2 days ago
  •  ...commercial, across all manufacturing sites. This role serves...  ...robust quality systems, processes, and controls are in...  ...regulatory requirements. Lead and support internal...  ...manage complex projects/teams within corporate...  ...background in Biologics or Cell and Gene Therapy Manufacturing... 
    Work experience placement
    Visa sponsorship
    Work visa
    Flexible hours

    ProKidney

    Winston Salem, NC
    8 days ago
  •  ...the CEO, CFO, operational leaders, sales team, and marketing team to ensure the...  ...managers, general contractors, developers, manufacturers, and other strategic customers • Develop...  ...systems • Develop a consistent sales process that can be taught, measured, and scaled... 
    For contractors

    Cogent Talent Solutions

    Winston Salem, NC
    13 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Manufacturing Cell Processing Team Lead. Be the first to apply!