Senior QC Microbiology Lead, cGMP & EM Programs

AbelZeta Inc; Rockville (MD); On-site; USD 133,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401k match

Paid holidays and leave

Job summary

AbelZeta Inc is seeking a Senior Manager of Quality Control Microbiology to lead QC microbiology operations at our cGMP facility in Rockville, MD. The role directs environmental monitoring, CCS, aseptic processes, and sterility programs for Phase I/II clinical manufacturing and commercial readiness.

You will mentor staff, drive CAPA investigations, and collaborate across Manufacturing, QA, Validation, Facilities, and external partners to ensure robust contamination control and sterility

Qualifications

• Bachelor of science or above in Microbiology, Biology, Molecular Biology, or related Life Sciences.
• Minimum of 8 years of QC microbiology experience in regulated pharma/biotech environments; CGT exposure preferred.
• Strong knowledge of cGMP, USP, Ph. Eur.; sterility assurance principles.
• Hands-on environmental monitoring and ISO 5/BSL-2 aseptic processing.
• Experience leading OOS, deviations, CAPA, and environmental excursions.

Responsibilities

• Lead development and continuous improvement of phase-appropriate EM and EMPQ programs.
• Direct EM programs within ISO cleanrooms and cell processing suites, including sampling and data review.
• Provide oversight for CCS and sterility assurance per FDA/EU requirements.
• Lead QC Microbiology team with scheduling, training, and data review.
• Oversee APV/AOQ, cleaning/disinfection validation studies.
• Ensure compliance with data integrity, safety, and lab procedures.
• Drive root-cause analysis and CAPA effectiveness for investigations.
• Prepare/approve protocols and reports, SOPs, and risk assessments.
• Collaborate with Manufacturing, QA, Facilities, Validation, and external partners.

Skills

Leadership

QC microbiology

cGMP

Environmental monitoring

CAPA investigations

Cross-functional collaboration

Regulatory compliance

Mentoring

OJT

Education

Bachelor's degree in Microbiology/Biology

Tools

Laboratory SOPs

Job description

AbelZeta Inc is seeking a Senior Manager of Quality Control Microbiology to lead QC microbiology operations at our cGMP facility in Rockville, MD. The role directs environmental monitoring, CCS, aseptic processes, and sterility programs for Phase I/II clinical manufacturing and commercial readiness.

You will mentor staff, drive CAPA investigations, and collaborate across Manufacturing, QA, Validation, Facilities, and external partners to ensure robust contamination control and sterility