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 Principal Process Engineer to join our EU Manufacturing team in a 6-month Galapagos contract.

Provide technical and operational leadership to GMP operations at decentralized CAR-T manufacturing sites across EU. Manage and prioritize (multiple) multifunctional core team activities and drive decision making within the company. Lead the implementation of activities for CAR-T manufacturing processes and products. Drive decentralized manufacturing units through life cycle process validation requirements. Contribute to and translate strategies from CMC team, network committee and platform committee into an integrated planning and defined deliverables within the manufacturing department.

Principal Accountabilities:

·       Drive implementation of late-stage activities e.g. process performance qualification, aseptic process validation,

regulatory

submissions, process training and technical support.

·       Contribute to and translate strategies into executional actions by the manufacturing team within the EU network.

·       Process lead for products from early clinical stage through pivotal/ commercial readiness including life cycle process

validation activities.

·       Lead/ Support a team of (Sr) Process Engineers and manufacturing specialists in implementing strategy at the

Decentralized Manufacturing units (DMU).

·       Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell

culturing platform. Author and review governing documents e.g.  electronic batch record, SOPs, protocol, reports.

·       Integrate internal stakeholders and 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.

·       Liaise with the central reference site teams to execute production for site qualification activities.

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

module as process SME.

·       Manage and prioritize multiple, multifunctional, core team activities and drive decision making within the company.

·       Identify and lead continuous improvement initiatives. Ability to understand the impact beyond manufacturing and align

with all stakeholders for effective implementation.

Working Relationships:

It is expected that the Principal Process Engineer will integrate within the Global and Regional (EU and US) Technical Operations teams and QA for alignment on activities relating to company goals and objectives including to clinical manufacturing, central site operations, training, quality & compliance, transferring technology and late stage/ commercial readiness

Who are you?

• PhD or MSc in biotechnology, life sciences, engineering with 8+ years experience, or 15+ year relevant professional work experience.

• Extensive knowledge and understanding of cell & gene therapy principles and processes, GMP manufacturing, technology transfer and process validation life-cycle.

• Experience in leading activities for late stage and commercial CAR-T therapy manufacturing.

• 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 leading projects at CDMOs highly desirable

General skills:

• Strategic mindset with the ability to drive implementation within own team and across multiple collaborating functions.

• Ability to be flexible with changing priorities.

• Functionally plan and organise own team activities

• Result-driven and can-do mindset, without compromising quality and compliance.

• Excellent verbal and written communication skills with the ability to collaborate effectively across different departments and functions.

Language Skills:

• Strong interpersonal skills and written and spoken fluency in English.

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…!