Senior Manager, Quality Control, Microbiology

Recipharm Advanced Bio is seeking an experienced and highly motivated Senior Manager, Quality Control (QC) Microbiology to lead microbiological quality control activities supporting multiple client programs, products, and manufacturing operations. This role provides both technical and operational leadership for QC Microbiology, ensuring laboratory testing is performed accurately, efficiently, and in compliance with GMP regulations, approved procedures, client expectations, and applicable regulatory requirements.

Recipharm Advanced Bio is seeking an experienced and highly motivated Senior Manager, Quality Control (QC) Microbiology to lead microbiological quality control activities supporting multiple client programs, products, and manufacturing operations. This role provides both technical and operational leadership for QC Microbiology, ensuring laboratory testing is performed accurately, efficiently, and in compliance with GMP regulations, approved procedures, client expectations, and applicable regulatory requirements.

The Senior Manager will partner closely with Quality Assurance, Manufacturing, Analytical Development, Process Development, Validation, Engineering, Regulatory Affairs, and Project Management teams to support programs from development and technology transfer through clinical and commercial manufacturing. The ideal candidate will possess strong microbiology expertise, proven leadership experience, excellent problem-solving skills, and the ability to manage competing priorities in a fast-paced CDMO environment.

• Lead day-to-day operations of the QC Microbiology laboratory supporting multiple client programs and manufacturing activities.
• Ensure timely execution, review, and approval of microbiological testing for raw materials, in-process samples, finished products, stability programs, environmental monitoring, water systems, and manufacturing support activities.
• Establish laboratory priorities and allocate resources to meet manufacturing schedules, client commitments, and regulatory requirements.
• Monitor laboratory performance, workload, staffing, capacity, and turnaround times.
• Ensure testing is conducted in accordance with GMP requirements, approved procedures, specifications, protocols, and methods.
• Identify and resolve operational challenges that may impact laboratory performance, manufacturing timelines, or client deliverables.

• Provide oversight of environmental monitoring programs supporting GMP manufacturing operations.
• Author and oversee Environmental Monitoring Performance Qualifications (EMPQ) as required.
• Manage microbiological testing of water systems, clean utilities, and manufacturing support systems.
• Review environmental monitoring and utility data to identify trends, excursions, and potential contamination risks.
• Author quarterly Environmental Monitoring and Utility Trend Reports.
• Support Aseptic Process Simulations (Media Fills).
• Provide microbiological expertise during investigations involving contamination events, environmental monitoring excursions, bioburden concerns, sterility issues, and related quality events.
• Collaborate with Manufacturing, Quality Assurance, Engineering, and Validation teams to determine root causes and implement effective corrective and preventive actions.

• Lead investigations related to OOS, OOT, deviations, laboratory errors, environmental monitoring excursions, and microbiological quality events.
• Ensure investigations are scientifically sound, appropriately documented, and completed within established timelines.
• Review and approve investigation reports, laboratory assessments, and…