ProKidney
Manufacturing Cell Processing Team Lead
Winston-Salem, North Carolina, United States
Sponsorship not specifiedDetected 8 days ago
ExcelERPGMPCell CultureCommunicationCritical ThinkingMentoringOrganizational Skills
About the role
- This role involves overseeing day-to-day operations of the manufacturing team, troubleshooting issues, leading deviation and CAPA investigations, and mentoring staff.
- 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.
Responsibilities
- 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.
Requirements
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
- Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.
Nice to have
- 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.
- 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
- 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.
- Critical thinking and troubleshooting skills to handle unexpected events.
- Ability to exercise judgment within defined procedures and practices to determine appropriate actions.
Company info
- 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.
- Lead is a Subject Matter Expert (SME) in manufacturing processes, driving continuous improvement, ensuring high-quality GMP documentation, and promoting operational efficiency.
- Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.
- 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.
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.