Kindeva Drug Delivery · 1 week ago
Sr. Supervisor, QC Microbiology
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expKindeva Drug Delivery is a rapidly expanding pharmaceutical CDMO focused on saving lives and enhancing patient well-being. The Sr. Supervisor, QC Microbiology will lead a team of microbiologists to ensure product quality and adherence to regulatory standards, directly impacting patient health outcomes worldwide.
Manufacturing
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 (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
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 (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
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
Qualification
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 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 testing requirements
Experience leading microbiology laboratory operations in a CDMO or pharmaceutical manufacturing environment
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
MarketScreener
2026-01-01
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