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Recrutis recruits for Incyte - Leading NASDAQ biopharmaceutical company specializing in oncology and rare inflammatory diseases as part of expanding Drug Product manufacturing capabilities.
Your mission
Lead microbiological quality control activities to support production testing (IPC, DS, DP), environmental and utilities monitoring, aseptic processes, and coordination of outsourced testing. Ensure compliance with cGMPs, regulatory expectations, and internal quality standards.
Key responsibilities
Team leadership and management
* Lead microbiological QC team: resource allocation, planning, effective execution
* Performance management: coaching, technical guidance, professional development
* Training oversight: assign requirements, monitor training status for compliance
* Collaborative environment: create high-performance team aligned with Incyte values
Technical and operational excellence
* Environmental Monitoring: lead EM and Clean Utilities Sampling/Testing (UTY)
* Product testing: supervise In-process Control (IPC) and Drug Substance/Drug Product (DS/DP) microbiological testing
* Aseptic Process Simulation: responsible for APS testing activities, sterility assurance compliance
* Media management: manage incoming control testing of media and plates for APS
* Clean utilities monitoring: sampling and monitoring of controlled environments
External coordination and regulatory
* Outsourced testing oversight: coordinate Sterility, Mycoplasma, Viral safety, Cell-based assays
* Method management: oversee microbiological method verifications, tech transfer
* Health Authority inspections: active participation, ensure team readiness and compliance
* Cross-functional collaboration: lead root cause analyses, support regulatory submissions
Quality systems and compliance
* Quality Champion: ensure high compliance level, ownership, inspection readiness
* Deviation management: lead microbiology deviations, investigations, CAPAs
* Equipment qualification: ensure appropriate qualification and maintenance of microbiological QC equipment
* Protocol oversight: timely, accurate review/approval of protocols, reports, SOPs, work instructions
Your profile
Education and experience
* MSc or equivalent in microbiology, biotechnology, or related scientific discipline
* 10+ years microbiology QC experience within GMP biotech environment
* 5+ years substantial leadership experience in team management role
Technical expertise
* Strong knowledge of GMP microbiology, aseptic practices, environmental monitoring
* Experience in adventitious agent testing and coordination of external laboratories
* Proficiency in quality systems: deviation, CAPA, change control
* Experience in method validation, tech transfer, laboratory readiness
* Proven experience managing teams, fostering development and collaboration
* Ability to interact effectively with Health Authorities, lead teams through inspections
* Strong project management, organizational, and cross-functional communication skills
* Quality Champion mindset, compliance excellence
Languages
* French: fluent professional level
* English: fluent business level
What Incyte offers
* Direct impact on developing life-changing therapies
* cGMP excellence environment with highest quality standards
* Growth opportunities within international organization
* Safety-first culture with continuous process improvement
* Working conditions respecting sustainable development and Incyte ethical values
* Structured professional development programs
Seniority level
* Executive
Employment type
* Full-time
Job function
* Manufacturing and Quality Assurance
Industries
* Biotechnology Research and Pharmaceutical Manufacturing
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