Principal Engineer Global Manufacturing Sciences and Technology (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’.

For our Cell Therapy organization in Leiden, we are looking for a Principal Engineer Global Manufacturing Sciences and Technology (MSAT)

Scope

We are seeking an Principal Engineer Global Manufacturing Sciences and Technology (MSAT) to join the team in the Leiden Bio Science Park, The Netherlands. The Principal Engineer Global MSAT is and experienced engineer who provides technical/scientific guidance to progress product and process life cycle activities and works in close collaboration with a team of process engineers to drive CAR-T processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Lead authoring of regulatory filings and health authority questions related to Global MSAT related technical and process responsibilities.
• Lead workstreams and provide scientific and technical guidance to the process engineers related to the overall process validation lifecycle, stability and comparability study strategies.
• Lead development and implementation of innovative decentralized manufacturing solutions and offer expertise in troubleshooting related to GMP operations and technology transfers and clinical manufacturing.
• Provide technical expertise and guidance to optimize manufacturing procedures and progress towards commercial readiness of the decentralized CAR-T manufacturing platform.
• Build trust and foster positive relationships with the teams and key CMC, QA and RA stakeholders to create a supportive and collaborative work environment.
• Mentor and guide engineers, fostering a culture of innovation and excellence to identify and implement improvements in the cell therapy processes and procedures, including process/product change controls and automation/digitalization.
• Ensure compliance with relevant quality and regulatory requirements.

The Principal Engineer Global MSAT reports to the Director Global MSAT.

• MSc/PhD degree in life sciences, biotechnology, or related discipline
• 10+ year relevant work experience
• Demonstrated experience in authoring and reviewing regulatory submissions (IND, IMPD, BLA, MAA)
• Experience with process validation for cell therapy/biologics processes, GMP manufacturing, technology transfers, process development
• Experience in clinical/commercial manufacturing of cell & gene therapies and knowledge of ATMP regulations
• Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies
• Strategic mindset with the ability to drive initiatives from conception to implementation.
• Ability to be flexible with changing priorities
• Result-driven and can-do mindset, without compromising quality and compliance
• 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…!