Manager, Quality Control Microbiology

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual discretionary bonus program

Medical insurance

401K program

Other benefits

Job summary

Rentschler Biopharma, Inc. is seeking a Manager of Quality Control Microbiology in Milford, MA. This role oversees day-to-day microbiology lab operations, ensuring timely testing, staff scheduling, and GMP compliance.

The position emphasizes investigations, change management, and audit readiness, reporting to the Senior Manager of QC Microbiology. You will supervise and coach microbiology personnel, ensure proper training, and support internal and client audits.

Qualifications

• 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.
• Able to communicate effectively with QC Management and peers.

Responsibilities

• Manage day-to-day microbiology lab operations and testing.
• Develop testing schedules, resource plans, and personnel assignments.
• Monitor workload, queues, inventory, and on-time delivery of results.
• Ensure testing activities comply with GMP and approved procedures.
• Support deviations investigations, CAPAs, and change controls.

Skills

Leadership

Communication

Documentation

Quality assurance

Education

BS in Microbiology or related field

Tools

Microsoft Office

Job description

About Rentschler Biopharma

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.

Job Overview

The Manager, Quality Control Microbiology is responsible for the day-to-day management of microbiology laboratory operations, ensuring timely execution of testing activities, staff scheduling, and compliance with GMP requirements. This position focuses on operational execution, maintaining laboratory efficiency, and supporting investigations, change management, and audit readiness activities. The Manager reports directly to the Senior Manager, Quality Control Microbiology.

Duties and 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

Qualifications

• 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

Working Conditions

• Laboratory environment/equipment working within Microbiology Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, fax, copier
• Pace may be fast and job completion demands may be high
• Physical Requirements: Frequent lifting up to 10 lbs, Frequent standing/walking to work in lab environment for extended periods, Frequent sitting for extended periods to use computer

Base Pay Range

$110,000 - $150,000

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees' personal and professional wellness.

Benefits

• annual discretionary bonus program
• medical insurance
• our generous 401K program
• host of other benefits

Company Information (Repeated)

Rentschler Biopharma is a 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. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. 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, we pursue one vision together: advancing medicine to save lives.