Head of Technical Operations, US

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 of Technical Operations, US

Scope of the role:
The Head of Technical Operations - US will lead Galapagos' Technical Operations team in the US, implementing global standards locally and overseeing cross-functional decisions, including product releases. Managing a team of 20+ professionals across various domains such as Site Management, Quality Control, Manufacturing, Quality, and Supply Chain, this role is pivotal in driving operational excellence and regional success and in shaping the future of cell therapy manufacturing, ensuring our products meet the highest standards of quality and compliance.

Your role:

• Strategic Leadership: Drive the strategic direction of technical operations across multiple sites or partnerships, ensuring alignment with Galápagos' mission and long-term objectives.
• Technical Excellence: Act as the primary ambassador for Galapagos' technical expertise in the region, fostering relationships with key opinion leaders and thought influencers to advance the field of cell therapy.
• Business Development Support: Provide invaluable technical insights and due diligence support for potential business opportunities, leveraging your expertise to identify synergistic partnerships and strategic acquisitions.
• Standardization and Compliance: Implement and uphold stringent quality standards and regulatory compliance measures across all operations within the US region, safeguarding the integrity and safety of Galápagos' products.
• Regional Performance Optimization: Lead the evaluation, selection, and qualification of new manufacturing sites, overseeing seamless tech transfer efforts and maintaining strong relationships with partners to ensure operational excellence.
• Risk Management: Proactively identify and mitigate risks associated with decentralized manufacturing operations, developing robust contingency plans to ensure business continuity and minimize disruptions.
• Remote Management and Communication: Utilize innovative remote management techniques and communication platforms to foster a culture of collaboration, transparency, and accountability across geographically dispersed teams.
• Performance Monitoring and Improvement: Establish key performance indicators and metrics tracking systems to continuously monitor and enhance the performance of manufacturing sites, driving a culture of continuous improvement and operational excellence.
• Regulatory Compliance: Ensure strict adherence to all applicable regulatory requirements and industry standards governing cell therapy manufacturing in the USA, maintaining compliance with FDA regulations, GMP standards, and best practices.
• You report directly into the Global Head of Technical Operations and sit in the Leadership team of Technical Operations and Development

Who are you?

• Education: MSc/PhD in a relevant scientific or engineering field (e.g., bioengineering, biotechnology, cell biology).
• Experience: 15+ years in biopharmaceutical operations, with a focus on cell therapy production, development, and decentralized operations. Comprehensive knowledge of regulatory requirements in the USA.
• Skills: Strong leadership, communication, decision-making, problem-solving, and risk management skills. Experience in remote management and driving continuous improvement initiatives.

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…!