Sr. Technical Writer MSAT - Leiden (NL), Consultant (6 months)

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.

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 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.

For our Cell Therapy organization in Leiden, we are looking for a Senior Technical Writer contractor to join us for a 6-month assignment.

Project Scope

We are seeking a Senior Technical Writer to work with the Global MSAT and the Viral Vector team in the Leiden Bio Science Park, The Netherlands. In this role you will play a key role in ensuring high-quality, compliant, and scientifically sound documentation to support process and analytical development, validation, and regulatory readiness in a cell therapy environment.

Your mission

• Author and maintain key documentation for the Global MSAT and Viral Vector team, such as process descriptions, scientific reports, comparability protocols and reports, risk assessments, documents to support investigations, deviation management, SOPs, and regulatory submission content.

• Collaborate with cross-functional teams within and outside of the CMC organization (Manufacturing, PD, QC, AD, QA, RA,) as well as CRO and CDMO organizations, to gather, verify, and standardize technical content.

• Support regulatory submissions by contributing to and formatting CMC sections for INDs, IMPDs and responses to health authority questions.

• Ensure compliance with cGMP, GDP, and internal documentation standards.

• Manage document lifecycle in electronic systems, ensuring version control and timely updates.

• Promote documentation best practices, including template development, training, and continuous improvement of writing standards.

Who are you?

• PhD degree in life sciences, biotechnology, engineering or related discipline with at least 7 years work experience or MSc with an equivalent level of experience

• Demonstrated experience with cell & gene therapy processes (e.g. CAR-T, viral vectors), GMP manufacturing, technology transfer, process validation and/or process development

• Proficiency in regulatory and technical/scientific writing for GMP environments

• Ability to translate complex technical/scientific concepts into structured, clear, and concise content

• Familiarity with document management systems (e.g. Veeva) and quality systems

• Excellent attention to detail, organization, and version control

• Strong communication and collaboration skills across diverse stakeholders

What's in it for you?

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

To streamline our hiring process, we kindly request that only individual freelancers and our preferred vendors submit CVs directly to us. Applications sent by non-preferred agencies, recruitment firms, or other third parties on behalf of freelancers will not be considered. This approach helps us maintain an efficient and direct connection with top talent, ensuring a smooth experience for all involved.