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QC Director, Microbiology

Winston-Salem, North Carolina, United States

Position Summary

The QC Director- Microbiology is responsible for leading and developing microbiology functions supporting clinical and commercial manufacturing in areas that include Environmental Monitoring (EM), sterility assurance, microbiological testing, product release and contamination control strategies across GMP manufacturing and laboratory environments. This role will serve as a subject matter expert for microbiological aspects of site and laboratory operations and related regulatory compliance.

Responsibilities

  • Lead and manage the QC Microbiology team ensuring alignment with site and corporate quality objectives.
  • Define and implement strategies for microbial control, environmental monitoring, and sterility assurance suitable for clinical and commercial phases.
  • Serve as a microbiology subject matter expert (SME) in internal initiatives, regulatory inspections, and cross-functional teams.
  • Build organizational capability by identifying talent needs, supporting staff development, and fostering a culture of compliance and continuous improvement.
  • Oversee the design, execution, and trending of the EM program for classified cleanroom areas used in aseptic and biological production.
  • Ensure the program meets all applicable GMP regulations and evolving expectations as the facility prepares for commercial licensure.
  • Direct investigations of microbial excursions, including identification of root causes and implementation of effective CAPAs.
  • Lead sterility assurance initiatives for all aseptic and controlled processes including facility, personnel, utilities, and material flows.
  • Collaborate with Manufacturing, QA, and Validation to ensure appropriate controls are in place to prevent contamination and ensure product sterility.
  • Serve as a key resource for sterility assurance risk assessments and contamination control strategy development.
  • Oversee microbiological testing of raw materials, in-process samples, and product samples including bioburden, endotoxin, and sterility testing.
  • Ensure compliance with validated methods and compendial requirements (e.g., USP, EP).
  • Prepare, review, or approve method validation, method transfer, and test protocols for microbial assays.
  • Prepare, review, or approve cleanroom qualifications and aseptic simulations. Create process support documentation as needed to support sterility assurance.
  • Support the development of microbiological methods where appropriate.
  • Ensure successful day-to-day operations and test schedules.
  • Review and approves QC testing forms.
  • Serve as subject matter expert of relevant QC Microbiology assays and process contamination control.

 Qualifications

  • BS in Microbiology, Biology, or equivalent.
  • Master’s degree or higher is a plus. 10+ years’ experience in a relevant field. At least 5+ years in management or leadership role overseeing microbiological functions.
  • Demonstrated experience in managing microbiology and analytical testing teams, including development and validation of methods, as well as day-to-day operations.
  • Extensive knowledge of microbiological testing methodologies (e.g., sterility testing, endotoxin testing, microbiological limits, mycoplasma assays or potency testing.
  • Deep understanding of regulatory requirements (e.g., 21 CFR 210, 211, 1271; USP, EP, ICH) as they apply to microbiological testing and sterility assurance in the pharmaceutical or biotechnology industry.
  • Strong experience in leading method development and validation for microbiological tests, as well as troubleshooting testing-related issues.
  • Strong knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics and cell and gene therapy products.
  • Excellent knowledge of laboratory operations, including equipment qualification, method validation, and the management of laboratory investigations and CAPAs.
  • Proven leadership and management of cross-functional teams, work under pressure, and meet tight deadlines while maintaining a focus on quality and regulatory compliance.
  • Strong communication skills, both written and verbal, with the ability to interact effectively with senior leadership, regulatory bodies, and internal stakeholders.

 

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.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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