Associate Director 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 an Associate Director Manufacturing Sciences and Technology (MSAT).

Scope of the role

We are seeking an Associate Director Manufacturing Sciences and Technology (MSAT) to join the team in the Leiden Bio Science Park, The Netherlands. The Associate Director MSAT provides technical and strategic leadership to drive CAR-T processes/products from early clinical stage through pivotal/commercial readiness. With a team of experienced process engineers, an important goal is to provide technical/scientific guidance to progress product and process life cycle activities and to support GMP operations at the point-of-care manufacturing units.

Your role

• Lead MSAT process engineers, providing technical and scientific leadership to progress to commercial readiness of CAR-T manufacturing platform.
• Lead workstreams and provide guidance to the process engineers related to the overall process validation lifecycle, stability, and comparability strategies.
• Manage the design/execution of process characterization, comparability, and stability studies at the central facility in Leiden.
• Lead authoring of regulatory filings and health authority questions related to technical process/CMC.
• Manage GMP operations support for technology transfers and clinical manufacturing, to ensure timely delivery of process and product impact assessments, root-cause investigations, troubleshooting, and escalations related to major/critical deviations.
• Build trust and foster positive relationships with the teams and key stakeholders to create a supportive and collaborative work environment.
• Promote a continuous improvement mindset to identify and implement improvements in the MSAT processes and procedures, including process/product change controls and automation/digitalization.
• Ensure compliance with relevant quality and regulatory requirements.

The Associate Director MSAT reports to the Director MSAT.

• MSc/PhD degree in life sciences, biotechnology, or related discipline
• 10+ year relevant work experience, including at least 4-year people management
• Experience in authoring 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
• Strong interpersonal, verbal, and written communication skills
• 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…!