Manufacturing Specialist, PoC, Specialist

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) .

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 want to challenge the impossible. 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-happeners’.

We are looking for a highly motivated Manufacturing Specialist EU to join our Manufacturing Point-of-Care Team in Leiden, The Netherlands.

Scope of the job

As our Manufacturing Specialist, you will provide operational expertise to our decentralized point-of-care manufacturing units for CAR-T cell therapies. You have a critical role in technical support through technology transfers and clinical manufacturing. You are an SME in aseptic training, and demonstrate a strong commitment to patients.

Your role

• Able to frequently travel and support technology transfer activities for the decentralized point-of-care manufacturing sites, including production training, aseptic operator and process validation, process qualification runs, and operational readiness.
• Provide 24/7 technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products that meet quality/regulatory requirements.
• Able to relay technical information and mentor peers. Contribute with technical training both, hands-on as well as documentation.
• Able to use technical writing to write and review electronic batch records, SOPs, protocols & reports.
• Closely collaborate with Quality Assurance, and other departments in order to support release of short vein-to-vein products.

You will report to the Manufacturing Manager.

Who are you?

• BSc/MSc in life sciences, biotechnology, engineering or related discipline.
• Experience with GMP cell & gene therapy processes, automated bioreactor, and technical writing. Previous aseptic training experience strongly preferred.
• Ability to prioritize effectively and be flexible with changing priorities under minimal supervision.
• Responsible for own projects while pursuing company goals in open collaboration.
• Self-motivated with can-do mindset, without compromising quality and compliance.
• Good interpersonal skills including verbal and written communication are essential in this collaborative environment. Our corporate language is English. For this role, fluency in French and/or German plus the ability to travel is required.

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…!