Senior Process Engineer EU Manufacturing

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

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

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’.

Scope of the job

We are looking for a Senior Process Engineer to join our EU Manufacturing team in a 6-month Galapagos contract. As Senior Process Engineer, you provide technical and operational leadership to GMP operations at decentralized CAR-T manufacturing sites across Europe. As an SME, you will be leading tech transfer activities for implementation of CAR-T manufacturing processes and products from early clinical stage through pivotal/commercial readiness. As project lead, you will be coordinating cross-functional teams to drive sites through life cycle process validation requirements.

Your role

• Drive technology transfers such as process performance qualification, aseptic process validation, regulatory submissions, process training and technical support.

• Lead/support operational activities through the stages of technology transfer and continued operations, as well as training and continuous improvement activities as process SME.

• Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Review electronic batch records, SOPs, protocols and author reports.

• Triage operational challenges and deviations with internal stakeholders and Decentralized Manufacturing units (DMUs) to ensure compliance and qualification/batch progress. Lead product/process investigations and define corrective/preventive actions.

• Perform data trending and analysis for Key Performance Indicators related to operational performance.

• Use project management skills to lead the implementation of change controls related to product/process changes within in the EU DMU network.

• Process lead for products from early clinical stage through pivotal/commercial readiness.

• Lead the DMU in execution of produce life cycle process validation activities through the stages of process qualification and continued process verification.

• Liaising with the central reference site lab team to generate the necessary material for site qualification activities.

• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.

Who are you?

• PhD or MSc in biotechnology, life sciences, engineering, or equivalent experience.

• 10+ year relevant work experience.

• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer and process validation.

• Experienced in QMS systems, e.g. Veeva.

• Proven cross-functional project management/leadership experience (with both internal and external stakeholders preferred).

• Strong understanding of GMP regulations and experience regulatory submissions (IND, IMPD, BLA, MAA).

• Experience in late-stage development and commercial readiness within life sciences.

• Ability to be flexible with changing priorities.

• Strategic mindset with the ability to drive implementation.

What’s in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

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