Senior QC Microbiology Leader – GMP Cell Therapy

Automatic Data Processing, Inc.; Rockville (MD); On-site; USD 133,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k match

Paid holidays and leave

Job summary

AbelZeta Inc is seeking a Sr. Manager of Quality Control Microbiology in Rockville, MD.

This leadership role directs QC microbiology operations supporting Phase I/II and clinical manufacturing, with emphasis on environmental monitoring, EMB and EMPQ strategy, and contamination control. The candidate will lead investigations, CAPA, staff development, and cross-functional collaboration to ensure FDA/EU GMP compliance and sterile processes across ISO 5/7/8 environments and BSL-2 cell processing

Qualifications

• Bachelor of science or higher in Microbiology or Life Sciences.
• 8+ years in QC microbiology in regulated pharma/biotech environments.
• Experience with cGMP, USP, Ph. Eur. and sterility principles.
• Leadership of investigations, CAPA and cross-functional collaboration.

Responsibilities

• Lead development and assessment of environmental monitoring programs and EMPQ plans.
• Direct EM programs in ISO cleanrooms and BSL-2 suites with data review and trend analysis.
• Oversee CCS governance and sterility assurance programs aligned with FDA/EU requirements.
• Mentor QC Microbiology staff, schedule resources, and oversee sampling and incubation.
• Lead validation studies for aseptic processing and cleaning, and support audits.
• Ensure compliance with data integrity, procedures and safety guidelines.
• Drive investigations for excursions and OOS results with root-cause analysis and CAPA.
• Prepare and approve protocols, reports, SOPs, and risk assessments.

Skills

Leadership

Communication

Problem solving

Project management

Education

Bachelor of Science in Microbiology

Job description

AbelZeta Inc is seeking a Sr. Manager of Quality Control Microbiology in Rockville, MD.

This leadership role directs QC microbiology operations supporting Phase I/II and clinical manufacturing, with emphasis on environmental monitoring, EMB and EMPQ strategy, and contamination control. The candidate will lead investigations, CAPA, staff development, and cross-functional collaboration to ensure FDA/EU GMP compliance and sterile processes across ISO 5/7/8 environments and BSL-2 cell processing