Sr. Supervisor, QC Microbiology

Kindeva Drug Delivery • Lexington, KY

72d

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. The Sr. Supervisor, Quality Control (QC) will lead a team of microbiologists performing critical microbiological testing of raw materials and finished products. You’ll ensure adherence to cGMP (Current Good Manufacturing Practice) standards, support method development and transfer, and play a key role in maintaining compliance with FDA (U.S. Food and Drug Administration) and USP (United States Pharmacopeia) requirements.

Requirements

• Bachelor’s degree in Microbiology, Biology, or related field.
• 5+ years of experience in a GMP laboratory environment.
• Strong experience with USP <61>, <62>, <51>, and <788> testing requirements.
• Demonstrated knowledge of purified water testing.
• Hands-on experience in method transfer, development, and qualification.
• Experience leading and developing team members.
• Strong knowledge of FDA regulations (21 CFR Parts 210, 211).
• Proficiency in Microsoft Office Suite.
• Excellent verbal and written communication skills.
• Strong background in aseptic technique, environmental and utilities monitoring, and technical writing.
• Ability to qualify to work with controlled substances.
• Positive attitude and ability to work effectively in a team environment.

Nice To Haves

• Experience with USP <71>, <85>, and <60>.
• Experience leading microbiology laboratory operations in a CDMO or pharmaceutical manufacturing environment.

Responsibilities

• Lead and supervise a team of microbiologists, providing technical guidance, training, and performance evaluations.
• Approve time off requests, manage workloads, and ensure testing goals are met on schedule.
• Participate in project meetings with internal stakeholders and external clients.
• Perform peer review of microbiological testing data, ensuring accuracy of raw data, calculations, and trending.
• Develop, qualify, and improve microbiological test methods for pharmaceutical and medical device products, including raw materials.
• Ensure adherence to USP <61>, <62>, <51>, and <788> testing requirements.
• Support or perform testing under USP <71>, <85>, and <60> as applicable.
• Demonstrate excellent aseptic technique in all microbiological work.
• 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.
• Ensure strict compliance with cGMP, SOPs, and regulatory requirements under 21 CFR Parts 210 and 211.
• Lead investigations and author or review technical documentation, including SOPs, deviations, and method qualifications.
• Identify technical or system issues and drive timely resolution.
• Maintain a safe and orderly laboratory environment, promoting proactive safety engagement.
• Lead continuous improvement of laboratory methods, workflows, and documentation to drive efficiency and accuracy.
• Train analysts on microbiological techniques and test methods.
• Share best practices and promote knowledge transfer within the QC Microbiology team.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees