Your Role: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.
Senior Microbiologist responsibilities include, but are not limited to:
- 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.
This position primarily works a standard daytime schedule from Monday through Friday but may occasionally require off-shift, weekend, or overtime work to support manufacturing campaigns, investigations, audits, and other business-critical activities.
Physical and work environment requirements:- Wearing PPE when entering the cleanroom space. PPE includes safety glasses, face masks, hoods, scrubs, sterile gowns, gloves, sleeves, and boot covers
- Sit and reach to use computers and other office/lab equipment
- Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
- Occasionally lift up to fifty (50) pounds
- View objects at close and distant ranges
- Occasional exposure to fumes, airborne particles, chemicals, vibration and biohazardous materials
Who You AreMinimum Qualifications:- 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
Preferred Qualifications:- 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
Pay Range for this position: $66,200-$99,300 per year.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
here.
RSREMD
