CMC Leader Cell Therapy, Leiden/NL

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We are looking for a CMC Leader Cell Therapy

Scope of the job

The CMC Leader Cell therapy is a critical hire for Galapagos; essential in securing the success of specific CART products. As such the role benefits from high visibility both internally and externally. Fundamentally, you are accountable for providing CMC strategy and maintaining oversight on all CMC activities of specific CART products. As CMC leader, you create high quality CMC plans and ensure effective communication and reporting of the project/portfolio status to relevant stakeholders.

Key to the success is to foster collaborative working relationships with cross-functional peers and CMC team members in order to deliver phase appropriate CMC packages required for the related product submissions.

You are part of a highly experienced community of professionals who enthusiastically support each other. At the same time, you work independently, entrusted with driving priorities and delivering strongly to business needs.

Your role

• Lead the CMC team and chair the CMC team meetings for the assigned products.
• Develop and provide the CMC strategy and tactics for assigned CART product(s) and manage CMC development plan for the respective product(s).
• Ensure continuous monitoring of progress of the CMC activities balancing scope, timelines, and risks.
• Participate as a member of the CART Project team and ensure CMC issues are brought to this team, inform, and advise if required.
• Support, Deliver and Maintain the CMC dossiers by providing strategic and tactical input in regulatory CMC dossiers (e.g., Quality IMPDs, Module 3 and QoS documents for INDs or marketing authorizations, CMC lifecycle management dossiers), in close collaboration with the functions/team members and RA.
• Support CMC response to HA questions in close collaboration with CMC regulatory lead.
• In close collaboration with (CMC) regulatory lead prepare and follow-up on formal CMC scientific and regulatory interactions with global regulatory agencies.
• Ensure with the functions/team members that CMC source documents for clinical trial applications/BLA/MAA (quality section) are timely available.
• Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
• Support the development and maintenance of specific SOPs for the GMP CMC activities, if applicable.
• Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.

The CMC Leader Cell Therapy role is based in Leiden (Bio Science Park), the Netherlands, frequent onsite presence is required.

You are a Biotech Professional with a Master’s degree Master of Science (MSc) or PhD in chemistry, pharmaceutical sciences or bio-engineering or equivalent by experience. You have at least 10 years’ experience in the Biotechnology industry with experience in the different phases of product lifecycle development.

Your experience:

• Current and strong knowledge of Development processes and GxPs and regulatory requirements.
• You have +10 years of experience in CMC development (Drug Substance, Drug Product, Method development and Analytics, Quality Operations) or in CMC project management for drug development projects/programs.
• You have a good knowledge of the drug development life cycle and the complex interaction between various functions (preclinical, clinical, CMC, regulatory etc.).
• You have a good knowledge of information systems and business processes related to project planning, budgeting, and reporting.
• A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential to success. A “can-do” attitude is highly appreciated.
• Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization.
• Excellent problem solving and analytical skills.
• Strong interpersonal skills resulting in an effective (intra- and cross departmental) team player.
• You have excellent analytical, planning and organizing skills.
• You have proven record of accomplishment of consensus building and conflict management in challenging situations, while continuously challenging the status quo.
• You have a customer focus.
• Stakeholder management has no secrets for you.

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…!