Supervisor, QC Microbiology
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: As the Supervisor of QC Microbiology – Environmental Monitoring, you will lead a team dedicated to contamination control and quality assurance in our cleanroom environments. Your leadership will be instrumental in maintaining high standards for microbiological monitoring, supporting critical batch and routine testing, and driving qualification activities. In this role, you will provide expert guidance, mentor junior staff, and play a key role in developing and executing self-sustaining, compliant microbiology programs. Your attention to detail, technical expertise, and collaborative mindset will directly contribute to the delivery of safe and effective pharmaceutical products.
Responsibilities:
- Lead the execution of environmental monitoring (EM) for batch, routine, and special projects, including qualification and experimental protocols
- Perform peer review of laboratory data and documentation for accuracy and completeness
- Provide technical guidance and hands-on training for microbiology team members
- Partner with the Microbiology Coordinator, Project Management, and Engineering/Validation to align testing priorities and timelines
- Supervise and qualify analysts on EM procedures (e.g., compressed gases, cleanroom, utilities)
- Drive continuous improvement efforts in test methods and laboratory processes
- Conduct EM assessments to determine program effectiveness and regulatory compliance
- Lead or participate in cleanroom and utility qualification activities
- Document all work clearly and thoroughly per cGMP standards
- Identify and resolve technical issues; escalate as needed for cross-functional resolution
- Participate in laboratory and cross-functional meetings to provide technical input
- Maintain a safe, organized, and compliant lab environment
- Train and supervise 1 or more direct reports in the EM team
- Support audit readiness and regulatory inspections
- Other duties as assigned by management
Qualifications:
- BA/BS degree in Microbiology, Biology, or related field with 8+ years of GMP laboratory experience
- MA/MS degree with 5+ years of GMP laboratory experience
- PhD with 3+ years of GMP laboratory experience
- Strong experience in aseptic technique, environmental and utilities monitoring, and microbiological testing
- Proven ability to mentor and lead teams in a regulated lab environment
- In-depth understanding of cGMP requirements and microbiological quality control practices
- Excellent analytical, organizational, and problem-solving skills
- Strong written and verbal communication skills
- Proficiency with Microsoft Office and electronic data systems
- Positive, team-oriented attitude and ability to work cross-functionally
- Qualified to work with controlled substances
Physical Requirements:
- Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust focus
- Must follow all cGMP and safety procedures within the department
- Must wear all required PPE and demonstrate safe work practices at all times
- Must use proper lifting techniques and be aware of surrounding hazards
- Must occasionally lift and/or move up to 20 pounds
# LI-Onsite
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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Other details
- Job Family D - Quality - QC Microbiology
- Job Function D - Quality
- Pay Type Salary
- Travel Required No
- Required Education Bachelor’s Degree
- Lexington, KY, USA