USA

Galapagos · (Senior) Process Engineer

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 the United States, we are looking for a (Senior) Process Engineer - US.

Scope of the role:

We are seeking a (Senior) Process Engineer to join the CellPoint Manufacturing Sciences and Technology (MSAT), providing technical-scientific expertise to the GMP operations at decentralized point-of-care manufacturing units in the United States. The (Senior) Process Engineer is a subject matter expert on the manufacturing process during development of the next generations of automated CAR-T, helping to drive processes/products from early clinical stage through pivotal/commercial readiness.

Responsibilities:

• Drive technology transfers and clinical manufacturing activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support.
• Elaboration process descriptions, process/product risk assessments, position papers, process/product impact assessments, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
• Lead/support Process Validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability.
• Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports.
• Review and elaborate content of regulatory filings and health authority questions related to technical process/CMC.
• Support and lead initiatives for Data Management & Analytics for real time process/product monitoring, Cocoon equipment lifecycle & reliability.

The (Senior) Process Engineer reports to the Director MSAT.

• BSc/MSc in life sciences, biotechnology, engineering or related discipline
• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development
• Knowledge of data management tools and statistical process controls is a plus
• Result-driven and can-do mindset, without compromising quality and compliance
• Responsibility for own projects while pursuing company goals in open collaboration
• Good interpersonal skills and written and spoken fluency in English

This is a remote position (at least for the first 6 months) requiring regular travel to the Netherlands and to the manufacturing sites. 

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.

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We are Galapagos : together we can make it happen…!