Senior Manager, QC Microbiology – Cell Therapy Manufacturing

AbelZeta; Rockville (MD); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Comprehensive Benefits Plan

401k match

Paid holidays, sick leave, and annual/

Job summary

AbelZeta Inc is seeking a Senior Manager of Quality Control Microbiology to lead the EM program, oversee ISO 5/7/8 cleanrooms, and drive sterility assurance, CAPA, and regulatory compliance. The role collaborates across QA, Facilities, and Validation to ensure robust contamination control for clinical manufacturing and commercial readiness.

The ideal candidate has 8+ years in QC microbiology within regulated biotech/pharma, experience with CGT, and a strong track record in investigations and

Qualifications

• Minimum of 8 years of QC microbiology experience in regulated pharma/biotech.
• Direct exposure to CGT manufacturing preferred.
• Strong knowledge of cGMP, USP and Ph. Eur. requirements.
• Hands-on EM, ISO 5/BSL-2 processing, microbial identification, and sterility testing.

Responsibilities

• Lead development and improvement of an EM program and EMPQ strategy.
• Direct EM programs in ISO 5/7/8 cleanrooms and BSL-2 cell processing suites.
• Oversee CCS and sterility assurance programs per FDA/EU Annex 1.
• Mentor QC Microbiology team and manage sampling, incubation, and data review.
• Support APV, AOQ, and cleaning validation studies.
• Ensure cGMP and data integrity across microbiology workflows.

Skills

QC microbiology

Leadership

Regulatory knowledge

Environmental monitoring

CAPA investigations

GMP compliance

Education

Bachelor's degree in Microbiology

Tools

EM sampling instruments

Sterility testing equipment

Job description

AbelZeta Inc is seeking a Senior Manager of Quality Control Microbiology to lead the EM program, oversee ISO 5/7/8 cleanrooms, and drive sterility assurance, CAPA, and regulatory compliance. The role collaborates across QA, Facilities, and Validation to ensure robust contamination control for clinical manufacturing and commercial readiness.

The ideal candidate has 8+ years in QC microbiology within regulated biotech/pharma, experience with CGT, and a strong track record in investigations and