Project Manager CMC Expansion

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the 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’.

We are looking for a Project Manager CMC Expansion - Leiden, NL

Scope of the job

We are seeking a highly motivated and experienced Project Manager to join our team to support the coordination and execution of CMC (Chemistry, Manufacturing, and Controls) activities. This position will involve supporting cross-functional teams to ensure the successful development and commercialization of our biotech products. The Project Manager will play a key role in supporting CMC leads and function heads in the planning, execution, and delivery of CMC projects, ensuring they meet timelines. The Project manager will also play a key role in supporting the expansion of the GMP manufacturing network.

Your role

• Project Planning & Coordination: Manage detailed project plans for CMC development and manufacturing activities, ensuring alignment with product development timelines.

• Cross-functional Team Support: Work closely CMC lead and internal teams including PD, AD, RA, MSAT, QC and Reg Tech OPS , to drive project progress and resolve issues as they arise.

• Risk Management: Identify potential risks to project timelines and work with function representatives and CMC Lead to executing mitigation strategies to address those risks.

• Resource Allocation: Support mapping of resource allocation across CMC functions to ensure that the project progresses according to schedule, while maintaining quality and cost efficiency.

• Continuous Improvement: Contribute to the development and implementation of best practices and process improvements in CMC project management.

• Documentation & Reporting: Maintain accurate project documentation, including progress reports, meeting minutes, and risk assessments.

Who are you?

• Experience with managing complex cross-functional projects

• Minimum a bachelor’s degree in biotechnology, life sciences, chemistry, or related field. Higher degree is preferred (MSc, PhD).

• Minimum of 5 years of project management experience, with at least 2 years in a biotech, pharmaceutical, or CMC-related environment. Ideally experience with ATMP CMC development and manufacturing.

• Strong understanding of Project Management processes, including GANTT generation, resources mapping, meeting preparation, execution, and follow up.

• Experienced with project management tools and software (e.g., MS Project, Asana, Jira).

• Excellent communication, and interpersonal skills, with the ability to work in a fast-paced, collaborative environment.

• Proven ability to manage multiple projects simultaneously and meet deadlines.

• PMP certification or equivalent project management qualification is a plus.

• Additional Skills & Attributes:

• Ability to analyze complex issues and provide clear, actionable solutions.

• High attention to detail and a results-oriented mindset.

• Ability to navigate ambiguity and lead teams through challenges.

• Strong problem-solving and decision-making skills.

• Fluent in English writing, reading, speaking

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…!

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.