About this role
Overview The QC Microbiology Senior Specialist is responsible for the coordination, oversight, and execution of QC Microbiology activities supporting the release of Drug Substance (DS), Drug Product (DP), In-Process Controls (IPC), Environmental Monitoring (EM), Utility Monitoring, and microbiological testing performed at the QC Bioplant. The QC Microbiology Senior Specialist ensures the compliant planning, execution, review, approval, and reporting of microbiological activities in accordance with GMP requirements and defined timelines. He/She acts as the subject matter expert (SME) for microbiological methods and testing, including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, Utilities Monitoring, and microbiological method verification, validation, and transfer activities.
The QC Microbiology Senior Specialist serves as the primary point of contact for Quality Assurance, Manufacturing, Supply Chain, Engineering, Validation, Warehouse, External Laboratories, and other Quality Control functions for the microbiological activities under his/her responsibility. In addition, the QC Microbiology Senior Specialist owns and drives quality records (deviations, investigations, CAPAs, change controls), provides technical leadership and coaching within the laboratory, contributes to continuous improvement and automation initiatives, and supports regulatory inspections and audits.[AD1.1] Key Responsibilities Plan, coordinate, and prioritize QC Microbiology laboratory activities to ensure timely support of production and batch release activities. Perform and/or oversee microbiological testing activities including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring.
Define, organize, and coordinate microbiological sampling plans and testing strategies for environmental and utility monitoring programs. Review, approve, and trend microbiological data, internal and external analytical results, ensuring compliance with GMP requirements and predefined lead times. Act as Subject Matter Expert (SME) for microbiological testing methods, specifications, method suitability, method verification, validation, and transfer activities.
Lead microbiology-related implementation activities for new products, methods, equipment, and technologies, serving as the interface between Analytical Transfer & Validation and QC Microbiology. Define and maintain microbiological specifications and testing strategies in compliance with applicable Pharmacopoeias (USP, Ph. Eur., JP), regulatory expectations, and internal requirements.
Own and lead quality events associated with microbiological activities, including deviations, laboratory investigations, root cause analyses, CAPAs, and change controls. Collaborate cross-functionally with QA, Manufacturing, Engineering, Validation, Supply Chain, Warehouse, and external laboratories to ensure efficient communication and issue resolution. Perform thorough review and approval of analytical documentation, raw data, calculations, laboratory records, reports, and electronic data to ensure data integrity and compliance.
Author, review, approve, and maintain SOPs, Work Instructions, protocols, reports, specifications, risk assessments, and quality documentation. Support laboratory inspection readiness and actively contribute to regulatory inspections, customer audits, internal audits, and responses to observations. Monitor laboratory performance through Key Performance Indicators (KPIs), identify trends, and propose actions to improve quality, compliance, efficiency, and turnaround times.
Contribute to the development, implementation, and optimization of laboratory digitalization and automation initiatives. Provide technical guidance, coaching, and training to technicians and junior laboratory staff. Support management of laboratory equipment, consumables, reagents, standards, maintenance, qualification, and calibration activities.
Act as a role model for GMP compliance, data integrity, quality culture, and business ethics. Contribute to resource planning, laboratory organization, and continuous improvement initiatives. Act as delegate for the Manager QC Microbiology when required.
Perform additional activities as assigned by management. Education and Experience Minimum Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or related scientific discipline with a minimum of 5 years of relevant experience in QC Microbiology within a GMP-regulated pharmaceutical or biotechnology environment. Strong hands-on experience with Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring.
Demonstrated experience with microbiological method verification, validation, transfer, and lifecycle management. Deep knowledge of microbiological testing, aseptic techniques, and applicable Pharmacopoeias (USP, EP, JP). Strong understanding of GMP regulations, Data Integrity principles, and quality risk management.
Proven experience leading investigations, root cause analyses, CAPAs, and change controls. Experience supporting regulatory inspections and quality audits. Strong problem-solving, analytical thinking, and decision-making skills.
Knowledge, Skills, Abilities High degree of autonomy, accountability, and ownership. Strong organizational and planning skills. Ability to coordinate activities and manage multiple priorities simultaneously.
Excellent communication and stakeholder management skills. Strong team-player mindset with demonstrated ability to influence cross-functional teams. Proactive, pragmatic, and continuous improvement oriented.
Ability to coach and mentor laboratory personnel. French: Fluent. English: Advanced (minimum C1).
Proficiency with LIMS, electronic quality systems, and Microsoft Office applications. Work conditions Work on weekends and outside standard working hours may be required. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. We Respect Your Privacy Learn more at: http://www.incyte.com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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