Sr. Manager, Quality Control Microbiology in Rockville, Maryland at Cellular Biomedicine Group Inc
Job Description
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.
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.
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