QC Microbiology Manager — GMP Lab Leader & Operations

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

Job summary

Rentschler Biopharma, Inc in Milford, MA is seeking a Manager, Quality Control Microbiology to lead daily microbiology lab operations, ensure GMP compliance, and drive investigations, CAPAs and change controls. The role emphasizes staff coaching, scheduling, and ensuring timely results in a fast-paced biopharma environment.

The position requires a BS in Microbiology or related field with 7+ years of relevant experience and 3+ years in a leadership role, along with strong knowledge of

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

Responsibilities

• Manage daily microbiology operations to ensure timely routine, stability, environmental monitoring, and non-routine testing.
• Develop and maintain laboratory testing schedules, resource plans, and personnel assignments
• Monitor workload, testing queues, sample inventory, and capacity to ensure efficient resources and on-time results
• Ensure completion of testing activities per procedures, GMP requirements
• Author, investigate, and support closure of deviations, CAPAs, and change controls
• Review lab documentation and data for accuracy and GMP compliance
• Support document revisions and continuous improvements of lab procedures
• Supervise and develop microbiology personnel; manage performance and training
• Ensure personnel training and qualification compliance
• Support internal audits, regulatory inspections, and client audits; maintain inspection readiness
• Monitor lab performance metrics and drive improvements in efficiency and compliance
• Oversee equipment maintenance, calibration, qualification, lifecycle activities
• Maintain safety requirements of lab and personnel

Skills

Quality control management

Microbiology expertise

GMP knowledge

Laboratory supervision

Microsoft Office

Education

BS in Microbiology or related

Job description

Rentschler Biopharma, Inc in Milford, MA is seeking a Manager, Quality Control Microbiology to lead daily microbiology lab operations, ensure GMP compliance, and drive investigations, CAPAs and change controls. The role emphasizes staff coaching, scheduling, and ensuring timely results in a fast-paced biopharma environment.

The position requires a BS in Microbiology or related field with 7+ years of relevant experience and 3+ years in a leadership role, along with strong knowledge of