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Principal Scientist QC Microbiology
Development - CMC
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Pleased to meet you, we are CellPoint, a Galapagos company. We’re a dynamic fast growing Biotech company in the business of changing lives.
Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.
Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. For more information, please visit www.cellpoint.bio.
For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for a Principal Scientist QC Microbiology
Scope of the role:
We are seeking a highly motivated Principal Scientist - Microbiology to join CellPoint’s Quality Control team in the Leiden Bio Science Park. The Principal Scientist will be involved in further designing a fit for purpose contamination control strategy which includes implementing a consistent Environmental Monitoring program. Furthermore, we aim to implement state-of-the-art automated rapid microbiology test methods for release testing which fit our point-of-care model. The Principal Scientist leads these method development projects which will have ground-breaking impact on the way release testing is commonly performed.
The Principal Scientist QC Microbiology reports to the Director QC.
- Develop compliant (rapid) test methods in-line with CellPoint’s release strategy
- Ensure a strong and compliant sterility strategy of our process (closed-system) and product
- Continue to design and implement a contamination control strategy for the point-of-care facilities
- Design and implement EM programs for both CellPoint and point-of-care facilities
- Ensure and support the quality of EM programs at the point-of-care facilities
- Act as the Subject Matter Expert for microbiology related topics at CellPoint and point-of-care facilities
- Co-drive innovation by keeping up-to-date with relevant literature, technology, regulatory updates and industry developments
Who are you?
- PhD degree in life sciences, biotechnology, or related discipline
- Strong demonstrated knowledge of Microbiology in a pharmaceutical/biotech setting, preferably 5 years or more experience
- Proficient in QC test methods for sterility, mycoplasma, endotoxin, gram staining
- Broad knowledge and experience with rapid (PCR-based or other) methods is a plus
- Strong interpersonal, verbal and written communication skills
- A passionate problem solver
- Ability to be flexible with changing priorities
- Self-driven and can-do mindset, without compromising quality
- Fluent in English
What’s in it for you?
You will be part of a fast growing and amazing company. As a ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.
We are Galapagos : together we can make it happen…!