Senior Microbiologist

Merck•Carlsbad, CA

23h•Onsite

About The Position

As a Senior Microbiologist within the Quality Control Microbiology team, you will serve as a technical subject-matter expert (SME) for microbiology testing and environmental monitoring in a GMP viral-vector manufacturing environment. You will lead method and equipment implementation, technical studies, investigations, quality-system projects, trend analysis, and process improvements. You will also provide technical direction to analysts and collaborate with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and client teams to resolve issues and deliver compliant, reliable results.

Requirements

Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related life-science discipline
7+ years of microbiology experience in a regulated GMP laboratory supporting biologics, sterile products, cell therapy, gene therapy, or viral-vector manufacturing OR High school diploma or GED 9+ years of microbiology experience in a regulated GMP laboratory supporting biologics, sterile products, cell therapy, gene therapy, or viral-vector manufacturing

Nice To Haves

Experience in investigations, CAPAs, change controls, technical documentation, SOPs, protocols, risk and trend reports, personnel training and competency assessment, and ALCOA+ data-integrity principles
Experience in CDMO, contract testing, or client-facing environments
Experience working with viral vectors, advanced therapies, or other biologics
Experience supporting regulatory inspections or client audits
Strong written and verbal communication skills, with the ability to explain microbiology concepts, investigations, risks, and recommendations to technical and non-technical stakeholders
Experience leading cross-functional projects
Experience with laboratory digitalization or automation
Lean Six Sigma, project-management, or quality-related certification

Responsibilities

Microbiology and environmental monitoring SME in audits and regulatory inspections.
Provide technical direction for microbiology testing, studies, and contamination-control activities.
Troubleshoot laboratory methods, equipment, software, and data issues.
Lead risk-based assessments for microbiology controls (HACCP, FMEA).
Implement and qualify new microbiology methods and equipment.
Author/execute study protocols and reports, including product qualification and disinfectant efficacy studies.
Trend and review testing/environmental monitoring to identify adverse trends and drive corrective actions (CAPAs).
Lead microbiology lab testing (growth promotion, preservation, identification, bioburden, endotoxin, media fill, indicators) and perform method validation/verification for USP/EP/JP compliance; lead investigations and CAPA/Change Control activities when needed.