is responsible for Microbiological Quality Control (QC) activities to support product testing (IPC, DS, DP), environmental and utilities monitoring, aseptic processes, and coordination of outsourced potency assay, microbial and viral safety testing, including cell-based assays and microscopy-based methods. This role ensures activities are conducted in compliance with cGMPs, regulatory expectations, and internal quality standards.
Key Responsibilities
- Act within compliance and legal requirements, as well as within company policies and procedures.
- Lead all microbiological QC activities including: Environmental Monitoring (EM) and Clean Utilities Sampling/Testing (UTY), In-process Control (IPC) and Drug Substance/Drug Product (DS/DP) microbiological testing, Aseptic process monitoring and support to sterility assurance
- Responsible for Aseptic Process Simulation (APS) testing activities, ensuring compliance with sterility assurance and regulatory expectations.
- Manage incoming control testing of media and plates for APS.
- Responsible for the sampling and monitoring of clean utilities and controlled environments.
- Oversee and coordinate outsourced testing for: Sterility, Mycoplasma, Viral safety, and Cell-based assays
- Oversee and coordinate microbiological method verifications and tech transfer and ensure laboratory readiness for new products/processes.
- Ensure timely and accurate review/approval of microbiology-related protocols, reports, SOPs and work instructions.
- Actively participate in inspections by Health Authorities and ensure readiness of the microbiology team.
- Support purchase requisitions and follow-up of purchase orders to ensure business needs are met in a timely manner.
- Create a positive, collaborative, and high-performance team environment aligned with Incyte values.
- Lead the microbiology QC team, ensuring proper resource allocation, clear team plans, and effective execution of lab activities.
- Manage performance, provide coaching, technical guidance and career development support to team members.
- Assign training requirements and monitor training status for the team to ensure compliance and continuous learning.
- Lead microbiology deviation management, investigations, CAPAs, and participate in cross-functional root cause analyses.
- Ensure appropriate qualification and maintenance of microbiological QC equipment.
- Act as Quality Champion for the microbiology QC group, ensuring a high level of compliance, ownership, and inspection readiness.
- Lead implementation of 5S and Lean practices in the microbiology laboratory.
- Monitor and report microbiology-related quality indicators and contribute to department budget planning.
- Ensure all QC activities comply with cGMPs and HSE policies, and foster a safety-first culture.
Requirements
- Significant experience in microbiology QC within a GMP biotech environment, including substantial leadership experience (typically demonstrated by 10+ years in the field and 5+ years in a leadership role, or equivalent combination of education, training, and experience).
- Strong knowledge of GMP microbiology, aseptic practices, and environmental monitoring.
- Proven experience managing teams and fostering development and collaboration.
- Experience in adventitious agent testing and coordination of external labs.
- Ability to interact effectively with Health Authorities and lead teams through inspections.
- Strong project management, organizational, and cross-functional communication skills.
- Proficiency in quality systems (deviation, CAPA, change control).
- Fluent in French and English.
- MSc or equivalent degree in microbiology, biotechnology, or related scientific discipline.
Energies, Envionment, Health & Safety
- We promote working conditions that respect sustainable development and Incyte's ethical values, with an emphasis on health, well-being and reducing our environmental impact.
- We ensure the efficient use of our resources and systems, with the aim of optimizing and increasing our energy performance.
- We are committed to identifying, recording, preventing and actively reducing all risks to the health and safety of our employees, through continuous improvement of our processes.
- Respecting, promoting and implementing the EEHS policy is an integral part of every function.
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.
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