Requirements: English
Company: WhatJobs
Region: Mechelen , Flanders
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 Cell Therapy organization in Leiden (the Netherlands) , we are looking for a Director Global Manufacturing Sciences and Technology (MSAT) Process Engineering .
Scope of the job
You are an experienced people leader who collaborates with a team of (senior) process engineers to drive CAR-T processes/products from early clinical stage through commercial readiness. As part of the Global MSAT team, you play a pivotal role in defining and driving strategies related to drug product design, process validation, stability, and scalability. In this role, you ensure the team maintains a strong focus on drug product development and optimization within the context of cell therapy manufacturing.
Your role
- Lead and mentor a team of experienced process engineers within the Global MSAT team, with an emphasis on building expertise in drug product process development, manufacturing and validation
- Lead workstreams and provide guidance to the process engineers related to the overall process validation lifecycle, stability and comparability study strategies
- Ensure the integration of drug product-specific considerations into overall CAR-T process development strategies, including container closure systems, formulation robustness, and filling processes
- Oversee and manage the design and execution of process characterization, comparability, and stability studies at the Galapagos Central Reference Facility in Leiden
- Provide technical expertise and guidance for drug product development, optimization of the manufacturing procedures to ensure progress towards commercial readiness of the decentralized CAR-T manufacturing platform
- Build trust and foster positive relationships with the teams and key CMC, QA and RA stakeholders to create a supportive and collaborative work environment
- Ensure close collaboration with leadership to establish clear workstreams and efficiency
- Promote a continuous improvement mindset to identify and implement advancements in cell therapy drug product manufacturing processes and automation/digitalization
- Ensure compliance with relevant quality and regulatory requirements
In this role, you will report to our Head of Global MSAT.
Who are you?
- MSc/PhD degree in life sciences, biotechnology, or related discipline
- 12+ years of relevant experience, with extensive expertise in drug product development and manufacturing for cell therapy or biologics
- Proven leadership, preferably managing a team of scientists or engineers
- Experience with clinical manufacturing and process validation for cell therapy/biologics processes, GMP manufacturing, technology transfers and drug product development
- Strong understanding of GMP regulations and experience with regulatory submissions (IND, IMPD, BLA, MAA)
- Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies
- Strategic mindset with the ability to drive initiatives from conception to implementation
- Ability to be flexible with changing priorities
- Result-driven and can-do mindset, without compromising quality and compliance
- Good interpersonal skills and written and spoken fluency in English
Whats 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 b