Clinical Bio-Academic QA/QC Officer
Clinical Bio-Academic QA/QC Officer
Leiden University Medical Center
Leiden, Netherlands
Are you passionate about advancing medical innovation and contributing to the development of new drugs within an academic setting? Do you have experience in ensuring quality and regulatory compliance within bio-academic research environments, particularly focused on pharmaceutical product manufacturing? Are you excited about working on the development, quality assurance, and regulation of challenge agents for use in controlled human infection models (CHIM), aimed at testing new vaccines and medication against infectious diseases? If so, we would like to meet you!
About your role
As a clinical bio-academic QA/QC officer at the Leiden University Medical Center (LUMC), you will play an essential role in promoting medical innovation by focusing on the development, quality assurance, and regulation of challenge agents for use in CHIM. In close collaboration with a dynamic and diverse team of both young and experienced professionals, you will work on the production of various challenge agents, such as viruses, bacteria, and parasites. You will be involved in both small-scale internal projects and large international research consortia, collaborating with various stakeholders, including researchers, physicians, pharmacists, and production staff. You will contribute to the development of new innovative drugs, particularly cell and gene therapies, crucial for testing new vaccines and medication against infectious diseases. As an expert in quality control and regulation, you will ensure that all production processes meet the highest standards and guidelines. You will work closely with internal and external partners to ensure that all activities are in compliance with applicable laws and regulations. In this role, you will contribute to groundbreaking research and participate in the development of new drugs that can have a global impact on the health and well-being of people.
About you
- A completed MSc or PhD degree in the field of biomedical, pharmaceutical, or similar disciplines.
- Strong communication skills, both orally and in writing.
- Excellent project management skills, with a focus on accuracy and goal orientation.
- Demonstrated interest and/or experience in production, quality control, and regulation related to challenge agents, such as viruses, bacteria, and/or parasites.
- Preferably experience working within a Good Manufacturing Practice (GMP) certified environment, or willingness to learn.
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