Senior Microbiologist

HAL Allergy Group is seeking a highly skilled Senior Microbiologist to join our team in Leiden, Netherlands. As a Senior Microbiologist, you will be responsible for coordinating and executing environmental monitoring and various microbiological tests to support incoming goods, during process control, and product release. You will also provide technical support on microbiological topics and lead problem-solving and implementation of improvements.

• Plan and coordinate laboratory sampling and testing activities, including environmental monitoring and microbiological analyses.
• Provide expert knowledge and in-depth understanding of microbiology-related topics.
• Perform microbiological sampling, method suitability, and routine analyses, including but not limited to:
  • Environmental monitoring of cleanrooms and water supplies
  • Sterility
  • Bioburden
  • Endotoxins
  • Growth promotion tests
  • Microorganism identification
• Be responsible for the activities of the QC Microbiology department, including but not limited to:
  • Monitoring and identifying microorganisms within the site
  • Ensuring proper handling of pathogenic microorganisms
  • Managing house isolate strains
  • Maintaining procedures and advising the Supervisor QC Microbiology on their accuracy
  • Processing and implementing regulatory requirements
  • Maintaining laboratory logs and documenting all data related to the QC Microbiology department
  • Ensuring all equipment on the QC Microbiology department is calibrated
  • Coordinating necessary steps to maintain equipment with the QC Qualification Specialist
  • Maintaining laboratory reference standards, reagents, and supplies
  • Writing, reviewing, and evaluating test results and reports for accuracy and completeness
  • Ensuring the laboratory meets EHS and GMP standards
  • Coordinating daily activities within the laboratory, monitoring inventory levels, and informing the Sample Management Team when new reagents and materials need to be ordered
  • Maintaining and following relevant Standard Operating Procedures (SOPs)
  • Assisting in problem-solving initiatives and resolving problems as needed
  • Initiating and following up on changes and monitoring deviations (e.g., OOS) and CAPAs, in collaboration with the Supervisor QC Microbiology
  • Maintaining 5S standards in the laboratory as needed
  • Providing training for QC Microbiology personnel
  • Escalating needs and improvements for the QC Microbiology lab to the Supervisor QC Microbiology
  • Acting as a backup and point of contact in the absence of the Supervisor QC Microbiology
  • Be willing to perform additional tasks as needed

• Minimum HBO knowledge level in Microbiology
• Minimum 10 years of experience in the pharmaceutical and/or biotechnological industry with sampling and testing of critical utilities and environmental monitoring within a GMP environment
• Experience with writing SOPs and reports
• Experience working in a pharmaceutical process environment with interaction with production processes
• Qualified to work in a Class A/B cleanroom
• Extensive experience with performing tests such as environmental monitoring, bioburden, growth promotion, endotoxins, and sterility
• Advanced knowledge of cGMPs and safety
• Experience with writing deviations and changes, and implementing CAPAs
• Knowledge of the Dutch and English languages in writing and speaking

HAL Allergy Group is a leading player in the development, production, and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We are a dynamic and innovative company that values open discussions, entrepreneurship, and close collaborations within our teams and with our international colleagues. If you are looking for a challenging and rewarding career in a fast-paced and growing company, we encourage you to apply.