Sr. Manager, Quality Control Microbiology

AbelZeta; Rockville (MD); Sur place; USD 150 000 - 190 000; Plein temps

Avantages offerts par ce poste

Comprehensive Benefits Plan

401k match

Paid holidays, sick leave, and annual/

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

QC microbiology

Leadership

Regulatory knowledge

Environmental monitoring

CAPA investigations

GMP compliance

Formation

Bachelor's degree in Microbiology

Outils

EM sampling instruments

Sterility testing equipment

Description du poste

AbelZeta Inc (AbelZeta) is a clinical-stage biotechnology company focusing on the development of novel cell therapy products for the treatment of advanced solid and hematological malignancies. We are seeking a highly motivated Senior Manager of Quality Control microbiology to join our team at our state-of-the-art cGMP facility in Rockville, MD.

This leadership role is responsible for directing all QC microbiology operations supporting Phase I/II/pivotal clinical manufacturing, as well as commercial readiness, including but not limited to environmental monitoring (EM), facility and EM qualification, aseptic process and operator qualification, and comprehensive Contamination Control Strategy (CCS) governance.

The successful candidate will provide technical and operational leadership, independently lead investigations, oversee qualification and validation activities, mentor laboratory staff, and drive cross-functional collaboration across AbelZeta’s different functional groups to ensure robust contamination control and sterility assurance in compliance with applicable regulatory requirements.

Responsibilities and Duties:

• Serve as the primary QC microbiology subject matter expert (SME), leading the development, implementation, and continuous improvement of a phase appropriate environmental monitoring (EM) program and environmental monitoring performance qualification (EMPQ) strategy. Support internal audits, partner assessments, and regulatory inspections, as needed.
• Direct the site viable and non-viable environmental monitoring (EM) programs within AbelZeta’s ISO 5, ISO 7, ISO 8 cleanrooms and BSL-2 cell processing suites, including sampling, data analysis, trend evaluation, and excursion management.
• Provide strategic technical oversight and continuous lifecycle maintenance for the facility-wide Contamination Control Strategy (CCS) and sterility assurance programs, in alignment with applicable FDA and EU GMP Annex 1 requirements, as appropriate.
• Lead, mentor and develop the QC Microbiology team, overseeing daily operations including resource and sample scheduling, on-job-training (OJT), routine sampling, sample incubation, data review, microbiological identification, and EM trending analysis.
• Support and oversee the execution of Aseptic Process Validation (APV /media fills), Aseptic Operator Qualification (AOQ), and cleaning/disinfection validation studies.
• Ensure strict adherence to cGMP requirements, data integrity standards, laboratory procedures, and applicable safety guidelines across all microbiology testing and monitoring workflows.
• Lead complex microbiological investigations involving environmental monitoring excursions, deviations, and Out-of-Specification (OOS) results. Apply formal root-cause analysis tools, assess potential product and process impact, and drive effective Corrective and Preventive Actions (CAPA).
• Author, review, and approve, as appropriate, qualification/validation protocols and reports, technical study protocols and reports, risk assessments, standard operating procedures (SOPs), and other controlled documents.
• Participate in audits and assessments of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other external partners, as applicable.
• Collaborate with Manufacturing, Quality Assurance, Facilities, Validation, and other cross-functional teams to maintain a robust contamination control program and support inspection readiness.
• Other tasks assigned.

Qualifications and Requirements:

• Bachelor of science or above in Microbiology, Biology, Molecular Biology, or a related Life Sciences discipline.
• Minimum of 8 years of relevant working experience related to QC microbiology, preferably in a regulated environment in the pharmaceutical/biotech industry. Direct exposure to cell and gene therapy (CGT) manufacturing is strongly preferred.
• Demonstrated working knowledge of cGMP regulations, applicable USP and European Pharmacopoeia (Ph. Eur.) requirements, and contemporary sterility assurance principles .
• Hands-on experience with environmental monitoring, aseptic processing in ISO 5/BSL-2 environments, microbial identification, and sterility testing methodologies.Demonstrated experience leading or supporting OOS, deviation, and environmental monitoring excursion investigations, including root-cause analysis, CAPA development, and effectiveness assessments.
• Strong leadership, communication, organizational, and problem-solving skills, with the ability to prioritize competing activities and collaborate effectively across functions.
• Ability to work effectively in a dynamic, fast-paced environment supporting clinical manufacturing and commercial-readiness activities.

Why You Should Join AbelZeta

• Join a high-growth and fast-paced organization.
• Defined career path and annual performance review and feedback process.
• Comprehensive Benefits Plan, including company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
• Competitive company 401k match.
• Paid holidays, sick leave, and annual leave.