Drug Product Development Lead MSAT

About the company

 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’.

Job description:

We are seeking a Drug Product Development Lead (Associate Director) to join our Global Manufacturing Sciences and Technology (MSAT) team in Leiden. In this role, you will provide technical leadership in drug product development, ensuring robust formulation, stability, and container closure strategies for our cell therapy products. You will be leading a team and will play a critical role in the collaboration to advance drug product development and to support the transition from clinical to pivotal and commercial readiness.

Your role

• Oversee drug product formulation strategies, optimizing stability, cryopreservation conditions, and excipient selection to enhance product quality and shelf life while ensuring compliance with pharmacy manual standards and guidelines.
• Design and oversee stability studies to support shelf-life determination and regulatory filings, ensuring adherence to relevant pharmaceutical standards.
• Lead evaluation of container closure systems for integrity, extractables/leachables, and suitability for storage and administration.
• Lead or contribute to regulatory submissions (IND, IMPD, BLA, MAA), ensuring comprehensive justification for formulation, stability, and drug product control strategies.
• Partner with cross-functional stakeholders to drive drug product innovation and process improvements.
• Mentor and develop the team, fostering a culture of technical excellence and continuous learning.
• Identify opportunities for new formulation technologies, automation, and process optimizations to improve robustness and product consistency, incorporating insights from pharmacy best practices.

Who are you?

• MSc/PhD in life sciences, biotechnology, or a related discipline.
• 10+ years of experience in biologics, cell therapy, or ATMP drug product development.
• Strong expertise in formulation development, stability studies, pharmacy manual studies, cryopreservation, and container closure integrity.
• Experience in regulatory filings (IND, IMPD, BLA, MAA) with a focus on drug product-related sections.
• Hands-on knowledge of ATMP regulations and global CMC expectations.
• Strong leadership skills, with the ability to mentor and develop a team.
• Strategic mindset, with a problem-solving and innovation-driven approach.
• Excellent communication skills in English, with the ability to work across global teams.

Link to vacancy:

https://www.workatgalapagos.com/join-us/drug-product-development-lead-msat