Senior Scientist Quality Control

Job description

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 Senior Scientist Quality Control


Scope of the role:

We are seeking a highly motivated Senior Scientist to join CellPoint’s Quality Control team in the Leiden Bio Science Park. The Senior Scientist will be involved in method optimization and validation. The techniques used include flow cytometry, PCR, immunological assays, luminescence, microscopy, etc. We aim to implement state-of-the-art automated (rapid) assays that fit the CellPoint point-of-care model, and this role ensures that the QC methods are compliant and suitable for the model. The Senior Scientist also provides support and expertise to the Analytical Development (AD) team during the method development stage, prior to validation. Your work will directly improve the product release strategy allowing more patients to be treated.

The Senior Scientist Quality Control reports to the Director QC.


Responsibilities

  • Design and perform method validation
  • Perform method transfers to our point-of-care facilities
  • Provide support for the development of new methods
  • Trend assay performance
  • Monitor QC results generated in-house and at the point-of-care facilities for completeness
  • Supervision and coaching of technicians
  • Perform laboratory investigations
  • Provide SME support to the point-of-care facilities
  • Write protocols and reports
  • Write procedures, deviations, change controls and CAPAs

The Principal Scientist Quality Control reports to the Director QC.

Job requirements

Who are you?

  • PhD degree in life sciences, biotechnology, or related discipline
  • A broad knowledge in flow cytometry, cell-based assays and PCR
  • Experience with troubleshooting instruments and methods
  • Knowledge of Microbiological methods is a plus
  • Previous experience in a pharmaceutical/biotech company in a quality control setting
  • Experience with GMP, ICH guidelines, pharmacopeia and regulatory requirements
  • Strong interpersonal skills and ability to convey ideas clearly.
  • 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…!