Director Global MSAT Process Engineering, 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 Director Global Manufacturing Sciences and Technology (MSAT) Process Engineering

Scope

We are seeking a Director Global Manufacturing Sciences and Technology (MSAT) Process Engineering to join the team in the Leiden Bio Science Park, The Netherlands. The Director Global MSAT Process Engineering is an experienced people leader who collaborates with a team of (senior) process engineers to drive CAR-T processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Lead and mentor a team of experienced process engineers within the Global MSAT team.
• Lead workstreams and provide guidance to the process engineers related to the overall process validation lifecycle, stability and comparability study strategies.
• Oversee and manage the design and execution of process characterization, comparability, and stability studies at the Galapagos Central Reference Facility in Leiden.
• 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.
• Ensure close collaboration with leadership to establish clear workstreams and efficiency.
• Promote a continuous improvement mindset 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 Director Global MSAT Process Engineering reports to the Head of Global MSAT.

• MSc/PhD degree in life sciences, biotechnology, or related discipline
• 12+ years relevant work experience
• Proven leadership, preferably managing a team of scientists or engineers
• Experience with clinical manufacturing and process validation for cell therapy/biologics processes, GMP manufacturing, technology transfers, process development
• Strong understanding of GMP regulations and experience regulatory submissions (IND, IMPD, BLA, MAA)
• 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 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. Relocation package to the Netherlands and flexible working hours can be discussed.

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