Winston-Salem, North Carolina, United States · On-site
Senior$345M raised
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 inv…
Winston-Salem, North Carolina, United States · On-site
Mid level
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Winston-Salem, North Carolina, United States · On-site
Senior$2.3B raised
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Winston-Salem, North Carolina, United States · On-site
Entry level
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Winston-Salem, North Carolina, United States · On-site
Entry level
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Winston-Salem, North Carolina, United States · On-site
Mid level
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Automotive Technician - Flow Audi of Winston Salem
Winston-Salem, North Carolina, United States · On-site
$45k–$100k/yr
Entry level
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Automotive Technician - Flow Audi of Winston Salem
Winston-Salem, North Carolina, United States · On-site
$45k–$100k/yr
Entry level
Job DetailsJob Location: Flow Motors of Winston-Salem - Winston Salem, NC 27127Flow Audi of Winston Salem is seeking an automotive technician with previous experience or an interest in participating in our paid apprentic…
Skills: Automotive repair, Vehicle maintenance, Attention to detail, Problem solving, Teamwork
Winston-Salem, North Carolina, United States · On-site
Senior+$3.9B raised
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Winston-Salem, North Carolina, United States · On-site
Mid level$3M raised
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Winston-Salem, North Carolina, United States · On-site
$23/hr–$45/hr
Mid level
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Winston-Salem, North Carolina, United States · On-site
Senior$3.5B raised
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Winston-Salem, North Carolina, United States · On-site
Entry level$3.9B raised
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Winston-Salem, North Carolina, United States · On-site
Entry level
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Automotive Technician - Flow Buick GMC Cadillac of Winston Salem
Winston-Salem, North Carolina, United States · On-site
$45k–$100k/yr
Entry level
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Winston-Salem, North Carolina, United States · On-site
$24/hr–$34/hr
Mid level$1.2B raised
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Winston-Salem, North Carolina, United States · On-site
Senior
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Winston-Salem, North Carolina, United States · On-site
Entry level$850M raised
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Laundry Worker - Wake Forest Baptist Linen Services
Winston-Salem, North Carolina, United States · On-site
Entry level
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Full-time
high school, associate degree, bachelor degree
Posted 2d ago
~40 hrs/week
Responsibilities
The Team Lead oversees daily manufacturing operations, including aseptic processing and cell therapy production, while ensuring strict adherence to cGMP guidelines. They are responsible for leading investigations into deviations and CAPAs, mentoring staff, and maintaining high-quality documentation standards.
Requirements
Candidates should possess an Associate or Bachelor degree in a science-related field and 4-6 years of relevant experience in biotechnology or cell processing. Proven expertise in a cGMP-regulated environment and strong leadership or troubleshooting abilities are essential.
Full job description
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.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. For more information, please visit www.prokidney.com.
Offices: 2000 Frontis Plaza Blvd, 250, Winston-Salem, North Carolina 27103, US · 8020 Arco Corporate Dr, 400, Raleigh, North Carolina 27617, US · 3929 Westpoint Blvd, Winston-Salem, North Carolina 27103, US · 399 Boylston St, Boston, Massachusetts 02116, US
Health CareTherapeuticsBiotechnologyPharmaceutical and biotechnology
How many Manufacturing jobs are open in Winston-Salem, NC right now?
There are currently 345 open manufacturing positions in Winston-Salem, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Winston-Salem, NC?
Companies currently hiring include Herbalife, Suntory Holdings Limited, RTX, ZIEHL-ABEGG Inc. North America, TekniPlex, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Winston-Salem, NC?
Yes — 6 of the 345 open manufacturing positions offer remote or hybrid work (1 remote, 5 hybrid).
How do I apply for Manufacturing jobs in Winston-Salem, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.