Manager, Quality Control Microbiology

Rentschler Biopharma•Milford, MA

5d•Onsite

About The Position

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Requirements

BS in Microbiology, biological science, or related scientific discipline
7+ years of related experience
3+ years in a management/leadership role(s)
Experience authoring deviations, CAPAs, and change controls
Strong knowledge of environmental monitoring, utility testing, and microbiological methods
Working knowledge of FDA, EMA, USP, and GMP regulations
Understanding of GMP’s with expectations of a commercial GMP environment
Must communicate effectively (verbal and written) with QC Management and peers.
Written communicate skills require full competence in following detailed written instructions, creating/revising SOP’s, and reports
Hands on skills and knowledge of quality lab operations including the operation and troubleshooting of lab equipment
Advanced knowledge of basic chemical and biological safety procedures/precautions
Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint

Responsibilities

Manage and prioritize daily microbiology laboratory operations to ensure timely execution of routine, stability, environmental monitoring, utility, and non-routine testing
Develop and maintain laboratory testing schedules, resource plans, and personnel assignments to meet operational timelines and business priorities
Monitor laboratory workload, testing queues, sample inventory, and capacity to ensure efficient utilization of resources and on-time delivery of results
Ensure completion of all assigned testing activities in accordance with approved procedures, protocols, and GMP requirements
Author, investigate, and support closure of deviations, laboratory investigations, CAPAs, and change controls and ensuring timely closure of these quality records
Review laboratory documentation, test records, and supporting data to ensure accuracy, completeness, and compliance with GMP and data integrity requirements
Support document revisions, and continuous improvements of laboratory procedures and documentation
Supervise, coach, and develop microbiology personnel, including performance management, workload balancing, and day-to-day technical guidance
Ensure personnel training, qualification, and compliance with all applicable training requirements
Support internal audits, regulatory inspections, and client audits, and ensure the lab maintains a continuous state of inspection readiness
Monitor laboratory performance metrics and implement actions to improve efficiency, compliance, and operational effectiveness
Oversee equipment maintenance, calibration, qualification, and lifecycle activities to ensure continued operational readiness
Maintain safety requirements of lab and lab personnel