Sr. Supervisor, QC Microbiology at Kindeva Drug Delivery

Lexington, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jan, 26

Salary

0.0

Posted On

18 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, GMP, FDA Regulations, USP Testing, Method Development, Team Leadership, Aseptic Technique, Technical Writing, Environmental Monitoring, Continuous Improvement, Laboratory Compliance, Data Review, Safety Procedures, Analytical Skills, Problem Solving, Communication Skills

Industry

Pharmaceutical Manufacturing

Description

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 Sr. Supervisor, Quality Control (QC) you 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. Responsibilities: Leadership and Oversight: 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. Microbiological Testing & Review: 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 (Microbial Enumeration), (Tests for Specified Microorganisms), (Antimicrobial Effectiveness Testing), and (Particulate Matter in Injections). Support or perform testing under USP (Sterility Testing), (Bacterial Endotoxins), and (Burkholderia Cepacia Complex Testing) as applicable. Demonstrate excellent aseptic technique in all microbiological work. 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. Compliance & Documentation: Ensure strict compliance with cGMP, SOPs (Standard Operating Procedures), and regulatory requirements under 21 CFR (Code of Federal Regulations) 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. Continuous Improvement: 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. Qualifications: Required Bachelor’s degree in Microbiology, Biology, or related field. 5+ years of experience in a GMP (Good Manufacturing Practice) laboratory environment. Strong experience with USP , , , and 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. Preferred: Experience with USP , , and . Experience leading microbiology laboratory operations in a CDMO or pharmaceutical manufacturing environment. Physical Qualifications: Regular use of hands to handle materials and laboratory equipment. Frequent use of computers and electronic communication tools. Standing and walking for extended periods during laboratory work. Ability to lift and move up to 25 pounds using proper techniques. Adherence to all site safety procedures and use of appropriate PPE (Personal Protective Equipment). Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide. # LI-Onsite California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer: 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. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Responsibilities

Lead a team of microbiologists in performing critical microbiological testing of raw materials and finished products while ensuring compliance with cGMP standards. Oversee method development, testing, and documentation to maintain product quality and patient safety.