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Position Summary:
Responsible for supervising daily operations within the manufacturing cell processing area, ensuring compliance with GMP standards, efficient production workflows, and team performance.
Essential Duties & Responsibilities:
• Direct supervision of manufacturing personnel including coaching, training, and performance evaluations.
• Oversee production schedules, batch documentation, and ERP transactions to ensure timely and accurate processing.
• Ensure compliance with GMP, FDA, EMA, and other regulatory standards.
• Review and approve batch records and support deviation investigations and CAPA implementation.
• Monitor production processes and adjust schedules as needed.
• Perform cGMP manufacturing tasks in an aseptic manner in an aseptic environment.
• Enforce safety protocols and procedures to ensure a safe working environment.
• Ensure compliance with all relevant regulations and standards.
• Coordinate with cross-functional teams including Supply Chain, Process Development, and Quality Assurance.
• Maintain audit readiness and support internal and external audits.
• Monitor and report key performance indicators such as batch release timelines and error rates.
• Collaborate with Senior Management in a dynamic environment, demonstrating outstanding communication skills.
Qualifications:
• Education/Training: Associate's or Bachelor's degree in a scientific discipline preferred; High school diploma acceptable with relevant experience.
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.
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