Huidige banen gerelateerd aan Senior Microbiologist - Leiden, Zuid-Holland - HAL Allergy Group

We are seeking a highly skilled and experienced Senior Microbiologist to join our team at HAL Allergy Group. 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.

• Coordinate and execute 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 ensuring they are up-to-date, and advising the Supervisor QC Microbiology
  • Processing administrative results and implementing regulations
  • 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 in good condition 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 always 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 all 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
  • Where necessary, maintaining 5S standards in the laboratory
  • Providing training for QC Microbiology personnel
  • Escalating needs and improvements for the QC Microbiology lab to the Supervisor QC Microbiology
  • Acting as a substitute and 'point of contact' in the absence of the supervisor
  • 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 word and writing

At HAL Allergy Group, we are a dynamic and innovative bio-pharmaceutical company that offers a great environment for self-starters. Our culture is characterized by entrepreneurship and a friendly and helpful atmosphere. The well-being of the patient is always our top priority. This combination forms the basis for an interesting and challenging environment.

• You will be part of a growing and dynamic bio-pharmaceutical company that offers a great environment for self-starters;
• A culture that is characterized by entrepreneurship and a friendly and helpful atmosphere. The well-being of the patient is always our top priority. This combination forms the basis for an interesting and challenging environment;
• You will be working in our dynamic headquarters in Leiden, where we work on the entire product pipeline from development to commercial production;
• You will be part of a company that is focused on helping people live a happier and healthier life;
• A market-conform salary that matches your responsibilities and experience;
• A 13th month;
• 30 vacation days;
• A company contribution to a pension package and health insurance.

We are interested in your CV, but we also want to know more about your ambitions, personality, and what drives you to apply. Please add a short motivation letter where you tell us why you are a match for this position.

The recruitment process consists of an introduction by the Recruiter, two interviews via video call or live at our office in Leiden with the Hiring Manager and/or a department specialist, followed by contract negotiations. Depending on the vacancy, an assessment may be part of the process.

Important message for recruitment and selection agencies HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search agencies (such as sending CVs) for vacancies placed on this or a referring website. All recruitment and selection agencies are requested to contact HAL Allergy Recruitment via - to inquire about a possible recruitment or staffing agreement with HAL Allergy.

HAL Allergy, for those looking for pharmaceutical innovation HAL Allergy is one of the European top players in the development, production, and distribution of allergen-immunotherapies for the treatment and prevention of allergic disorders. We focus on the development and production of modified allergen extracts for therapeutic and diagnostic purposes of respiratory and food allergies. At all our activities, the well-being of the patient is always our top priority.

At HAL Allergy, we stimulate open discussions, entrepreneurship, and close collaborations within the teams and with our international colleagues, in total more than 300 highly specialized people in various functions. If you also want to be part of an innovative and challenging pharmaceutical player, then this is an excellent opportunity

HAL Allergy has its headquarters in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continuous personal development. The HAL Allergy office is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district in the Netherlands in the field of Life Sciences & Health. The central station and the historic city center of Leiden are just 5 minutes' bike ride from our office.