Process Engineer MSAT, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

We are looking for a Manufacturing Science and Technology Process Engineer. 

Scope of the job

As Process Engineer, you join the Cell Therapy Manufacturing Sciences and Technology (MSAT) team, providing technical-scientific expertise to the GMP operations at decentralized point-of-care manufacturing units in Europe. You are 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.

Your role

• Drive MSAT related activities in technology transfers, such as engineering and qualification runs, to enable the expansion of the manufacturing network for clinical manufacturing.
• Act as MSAT subject matter expert during clinical manufacturing activities; e.g.:
  • Author process descriptions and generate relevant SOPs, Work Instructions and trainings to guide the POC manufacturing process at the PMUs in collaboration with the process engineering and process sciences team in MSAT
  • Contribute to the development of electronic batch records for the Point of Care (POC) manufacturing process
  • Lead product/process impact assessments and root cause investigations for deviations and define corrective/preventive actions
  • Lead the implementation of product/process related change controls
• Support Process Validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability.
• Review and contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.

The MSAT Process Engineer reports to the Director MSAT.

• PhD degree in life sciences, biotechnology, engineering or related discipline with 3 - 5 years work experience or MSc with an equivalent level of experience
• 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

What’s in it for you?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

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