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Associate Director, Manufacturing Operations (Contractor)

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

The Associate Director, Manufacturing Operations will oversee the day-to-day operations within the manufacturing organization, ensuring efficient, safe, and compliant production processes. This role is responsible for managing key operational activities such as management of log book and batch record reviews, addressing operational concerns in manufacturing, and handling shift report concerns to resolve issues quickly and maintain production continuity.

 

Essential Duties & Responsibilities:

  • Log Book & Batch Record Reviews:
    Supervise and conduct reviews of manufacturing log books and batch records to ensure accuracy, compliance with company policies, and consistency with operational standards. Ensure proper documentation and archival in accordance with regulatory or internal requirements. Provide routine status updates to ensure reviews remain on-track and within alignment with ProKidney Standard Operating Procedures (SOPs)
  • Operational Issue Resolution:
    Act as the primary point of contact for addressing operational concerns within the manufacturing organization. Collaborate with cross-functional teams such as Quality Assurance, Engineering, Quality Control, and Supply Chain to identify and resolve root causes of production issues, implementing corrective and preventive actions (CAPAs) as needed.
  • Shift Report Concerns Management:
    Manage and address shift report concerns from production teams, responding to operational disruptions or quality issues reported during shifts. Ensure that concerns are quickly investigated, resolved, and documented according to standard operating procedures (SOPs).
  • Continuous Improvement:
    Lead and drive continuous improvement initiatives within the manufacturing environment, focusing on enhancing operational efficiency, minimizing downtime, and optimizing quality standards. Collaborate with other departments to implement process optimizations and reduce costs.
  • Compliance & Manufacturing Standards:
    Ensure all manufacturing operations and processes comply with internal policies, industry standards, and regulatory requirements. Lead internal audits and inspections as required.
  • Team Leadership and Development:
    Lead, mentor, and develop a team of manufacturing operators, technicians, and supervisors. Foster a culture of teamwork, accountability, and continuous professional growth. Work with the training and support team to ensure staff have the necessary skills and knowledge to meet operational goals.
  • Production Scheduling and Resource Allocation:
    Collaborate with production planning to ensure effective scheduling of manufacturing activities, allocation of resources, and timely production output. Ensure production targets are met efficiently and with minimal waste.
  • Data Analysis & Reporting:
    Analyze operational performance data, track key performance indicators (KPIs), and generate regular reports for senior management on production metrics, operational challenges, and opportunities for improvement.

 

Qualifications:

  • Education:
    Bachelor's degree in Manufacturing, Engineering, Operations Management, or a related field (Master’s degree preferred).
  • Experience:
    10+ years of experience in manufacturing operations, with a focus on batch record reviews, and operational troubleshooting. Experience in manufacturing management and responding to shift report concerns is highly desirable.
  • Knowledge & Skills:
    • Strong knowledge of manufacturing best practices and industry standards.
    • Experience with log book and batch record reviews, deviation management, and root cause analysis.
    • Ability to identify, troubleshoot, and resolve complex operational issues in a fast-paced manufacturing environment.
    • Strong leadership, communication, and interpersonal skills.
    • Proven experience in implementing corrective actions and continuous improvement initiatives.
    • Proficiency in MS Office Suite (Excel, Word, PowerPoint) and familiarity with manufacturing software systems (e.g., SAP, MES).

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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