Senior QC Microbiology Lead: GMP & Investigations

Incyte Corporation; Yverdon-les-Bains; On-site; CHF 100,000 - 140,000; Full time

Job summary

Incyte Corporation in Yverdon-les-Bains, Switzerland, seeks a QC Microbiology Senior Specialist to coordinate and execute microbiological activities supporting release of DS/DP/IPC/EM and utilities monitoring. The role requires SME expertise in Bioburden, LAL, and Sterility testing, with leadership in data integrity and regulatory readiness.

You will drive deviations, investigations, CAPAs, and change controls, while coaching junior staff and ensuring timely, compliant results.

Qualifications

• Minimum Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or related discipline with at least 5 years in QC Microbiology within GMP-regulated pharma/biotech.
• Strong hands-on experience with Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring.
• Experience with microbiological method verification, validation, transfer, and lifecycle management.
• Deep knowledge of microbiological testing, aseptic techniques, and Pharmacopoeias (USP, EP, JP).
• Strong GMP, Data Integrity, and quality risk management understanding.
• Proven experience leading investigations, CAPAs, and change controls.
• Experience supporting regulatory inspections and quality audits.

Responsibilities

• Plan, coordinate, and prioritize QC Microbiology activities to support production and batch release.
• Perform and/or oversee microbiological testing including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring.
• Define sampling plans and testing strategies for environmental and utility monitoring programs.
• Review and trend microbiological data, internal and external results per GMP lead times.
• Serve as SME for microbiological testing methods, specifications, validation, and transfers.
• Lead microbiology-related implementations for new products, equipment, and technologies.
• Maintain microbiological specifications and testing strategies per Pharmacopoeias and regulatory requirements.
• Own quality events: deviations, investigations, CAPAs, change controls.
• Collaborate with QA, Manufacturing, Engineering, Validation, Supply Chain, and external labs.

Skills

QC Microbiology

GMP Compliance

Bioburden testing

Endotoxin (LAL)

Sterility Testing

Environmental Monitoring

Method Verification/Validation

CAPA & Deviations

Data Integrity

Cross-functional collaboration

Education

Bachelor's degree in Microbiology

Tools

LIMS

Electronic QA Systems

Microsoft Office

Job description

Incyte Corporation in Yverdon-les-Bains, Switzerland, seeks a QC Microbiology Senior Specialist to coordinate and execute microbiological activities supporting release of DS/DP/IPC/EM and utilities monitoring. The role requires SME expertise in Bioburden, LAL, and Sterility testing, with leadership in data integrity and regulatory readiness.

You will drive deviations, investigations, CAPAs, and change controls, while coaching junior staff and ensuring timely, compliant results.