Manufacturing Specialist US - East Coast

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 medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

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 Clinical Manufacturing & Technology Transfer team, we are looking for a Manufacturing Specialist in the East Coast region, in the US.

Scope of the job

Galapagos' Cell Therapy group is mainly located in Leiden, The Netherlands. For our USA expansion, we seek a Manufacturing Specialist to join the Clinical Manufacturing & Technology Transfer team organization, while based in the United States. As Manufacturing Specialist, you have a critical role in technical support through technology transfers and clinical manufacturing and you are an SME in aseptic training, production training, material management with a strong commitment to patients.

Your role

• Support GMP activities at the decentralized point-of-care manufacturing sites as part of tech transfers and clinical manufacturing, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
• Ability to frequently travel to the decentralized manufacturing units, to support operational readiness activities including but not limited to, production training, aseptic operator qualifications and process validations.
• Ability to use technical writing to write and review training material, electronic batch records, SOPs, technical reports and deviations.
• Ability to relay industry standards regarding GxP, best practices in aseptic processing and cleanroom behavior.
• Closely collaborates with others within Manufacturing, Quality Assurance, and other departments in order to support release of short vein-to-vein products. Support implementation of change controls and CAPAs.
• Ability to share 24/7 technical support service for the decentralized manufacturing units.
• Providing front-line troubleshooting, coordination of subject matter experts and deviation management to ensure timely release of CAR-T products that meet quality/regulatory requirements.

Who are you?

• BSc/MSc in life sciences, biotechnology, engineering or related discipline.
• Minimum 2 years of experience in GMP aseptic processing or GMP aseptic training. An innate ability to relay technical information is a must.
• Cleanroom knowledge and experience is a must. Experience working in ISO-7 cleanrooms specifically is a plus.
• GMP CAR-T therapy processes or automated bioreactor experience strongly preferred.
• Ability to prioritize effectively and be flexible with changing priorities under minimal supervision.
• Self-motivated with a 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.

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.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

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

Base compensation for this position ranges from $81,000 to $135,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.

In addition, this position is eligible for participation in both Galapagos’ performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.