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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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