Sr. Manager, QC Microbiology

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
Why Kindeva?
• Purpose-driven work environment
• Significant growth potential
• Collaborative team culture
• Direct impact on patient care
• Industry-leading innovation
At Kindeva – Lexington, KY, we’re not just testing samples—we’re safeguarding product quality and patient safety through world-class microbiological expertise.
The Impact You Will Make:
Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. The Senior Manager, Quality Control (QC) Microbiology will oversee all aspects of the Quality Control Microbiology laboratory, ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. This role will lead a team of skilled microbiologists, support method development and validation, manage environmental monitoring programs, and partner with cross-functional teams to deliver safe, effective products to patients worldwide.
Responsibilities:
Leadership and Management:
• Lead and manage the QC Microbiology laboratory team, ensuring accurate, compliant, and timely testing of raw materials, components, in-process, and finished products.
• Develop, mentor, and train microbiology staff to ensure a culture of scientific excellence, accountability, and continuous improvement.
• Plan and manage laboratory resources, including equipment, personnel, and testing schedules, to meet organizational goals.
• Foster collaboration across departments, including Manufacturing, Quality Assurance, and R&D.
Compliance and Quality Assurance:
• Ensure all microbiological activities comply with cGMP, FDA, USP, ICH, DEA, and OSHA regulations.
• Oversee the Environmental Monitoring (EM) program, including data trending, investigations, and CAPA (Corrective and Preventive Actions) implementation.
• Author, review, and approve standard operating procedures (SOPs), protocols, specifications, and reports.
• Lead and manage investigations into out-of-specification (OOS) or out-of-trend (OOT) results and implement effective CAPAs.
• Prepare for and actively participate in internal and external audits and regulatory inspections.
Scientific and Technical Expertise:
• Identify, develop, validate, and transfer microbiological methods for raw material, in-process, and finished product testing in alignment with GMP, USP, and ICH standards.
• Support plant and system validation projects by providing microbiological expertise.
• Oversee laboratory equipment qualification, maintenance, and calibration.
• Identify and implement new technologies and automation to enhance laboratory efficiency and compliance.
Continuous Improvement and Strategic Initiatives:
• Drive continuous improvement initiatives within the QC Microbiology function to optimize efficiency, data integrity, and overall laboratory performance.
• Develop and manage projects related to new laboratory capabilities or drug development programs.
• Audit and qualify external suppliers and contract testing organizations to ensure compliance with Kindeva’s quality standards.

Qualifications:
Required
• Bachelor’s degree (BS) in Biology, Microbiology, Biochemistry, or related scientific field.
• Minimum 10 years of experience in a pharmaceutical or biotechnology laboratory, with at least 3+ years leading microbiology operations.
• In-depth knowledge of cGMP, USP, and ICH regulatory requirements.
• Proven experience managing Environmental Monitoring (EM) programs, microbiological testing, and laboratory compliance systems.
• Strong leadership and team development skills with the ability to motivate and mentor staff.
• Excellent communication, organization, and technical writing skills.
• Hands-on experience with microbiological instrumentation and aseptic processing environments.
• Experience with deviation investigations, OOS/OOT analysis, CAPA, and audit readiness.
Preferred:
• Advanced degree (MS or PhD) in Microbiology or related field.
• Experience supporting both development and commercial manufacturing environments.
• Prior experience in a CDMO or multi-product facility.
• Demonstrated success in implementing laboratory automation or digital data management systems.
• Certification or training in Lean, Six Sigma, or related continuous improvement methodologies.


Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.

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