Sr. Manager, Quality Control Microbiology

Automatic Data Processing, Inc.; Rockville (MD); Sur place; USD 133 000 - 183 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401k match

Paid holidays and leave

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Leadership

Communication

Problem solving

Project management

Formation

Bachelor of Science in Microbiology

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr. Manager, Quality Control Microbiology

Quality FullTime Management Rockville, MD, Rockville, MD, US

Salary Range: $132,643.00 To $183,250.00 Annually

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 microbi o log y to join our team at ou r state-of-the-art c GMP facility in Rockville, MD.

This leadership role is responsible for direc ting all QC microbiology ope rations su pporting Phase I/II / pivotal cl inica l manu fact uring , as well as commercial rea dines s , in cludin g but not l imited to e n viron mental monit oring (EM) , f ac ility and EM qualificat ion , aseptic p rocess and ope rator qualifi cation , 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 di fferent functi onal gro u p s 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.