Head Cell Therapy CMC Development Strategy - 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 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 small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

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’.

We are looking for a
Head Cell Therapy CMC Development Strategy in Leiden (NL).

Scope of the role:

As the Head of Cell Therapy CMC Development and Strategy, you will lead our team in developing and executing strategies for manufacturing cell therapies in our decentralized model. With a focus on driving innovation and excellence, this role is instrumental in advancing our cell therapy pipeline from early development through regulatory approval.

Your role:

• Strategic Leadership: Lead development activities for cell therapy, including process and analytical method development, to advance our pipeline.
• CMC Strategy Development: Develop comprehensive strategies for assets in early and late-stage clinical trials, ensuring alignment with corporate objectives and regulatory requirements.
• Cross-Functional Collaboration: Collaborate with key departments, such as Discovery, Clinical Development, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure seamless execution of development plans and compliance with regulatory expectations.
• Innovation Driving: Spearhead innovation and advancements in the T cell field, driving new discoveries and developments to push the boundaries of science.
• Stakeholder Management: Manage internal and external stakeholders, providing essential management information to senior leadership.
• Scientific Direction: Set the scientific and technical direction for Manufacturing, guiding our efforts towards excellence and success.
• Risk Management: Identify and mitigate risks, ensuring the continuity of critical material and product supply, and driving performance monitoring to maintain high standards.
• You report directly into the Global Head of Technical Operation and you sit in the Management team of Technical Operations and Development

Who are you?

• Education & Experience: 
  • You hold an MSc/PhD degree in life sciences, biotechnology, or a related discipline. 
  • You bring over 15 years of experience in a global biotech environment
  • You demonstrate a proven track record in managing teams and partners.
• General Skills: 
  • You have a wealth of experience in authoring regulatory submissions (IND, IMPD, BLA, MAA) 
  • You possess expertise in cell selection, genetic cell engineering, automated bioreactors, flow cytometry, and advanced therapy process development.

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.

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