Senior Technical Writer MSAT Leiden • Panda International

An international biopharmaceutical company is seeking a Senior Technical Writer to support process and analytical development, validation, and regulatory readiness within its cell and gene therapy programs. Based in Leiden, Netherlands, this role will collaborate closely with the Global MSAT and Viral Vector teams to deliver high-quality, compliant technical documentation in support of CAR-T and Lentiviral Vector (LVV) programs.

Key Details:

• Start Date: ASAP

• Contract Duration: 6 monthS

• Location: Leiden, Netherlands (2–3 days on site/week)

• Languages: English required

• Interview Process: Streamlined – fast turnaround

This assignment provides critical support for documentation and reporting activities across MSAT and Viral Vector teams, contributing to regulatory filings, process development, and compliance initiatives. The consultant will ensure that scientific content is accurate, consistent, and audit-ready, supporting collaboration across key functions including QC, QA, RA, AD, and PD.

• Author and maintain technical documentation, including process descriptions, scientific reports, SOPs, risk assessments, comparability protocols, and deviation/investigation reports.

• Prepare and support CMC sections for INDs, IMPDs, and responses to health authority questions.

• Collaborate cross-functionally with Manufacturing, QC, QA, RA, PD, AD, and external partners (e.g., CROs, CDMOs) to gather and verify scientific data.

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

• Manage document lifecycle using systems such as Veeva, ensuring proper version control, review, and approvals.

• Drive documentation excellence through template development, training, and continuous improvement of writing standards.

• PhD or MSc in Life Sciences, Biotechnology, or Engineering, with 7+ years of relevant experience.

• Experience in cell and gene therapy - preferably in CAR-T or LVV manufacturing.

• Proven expertise in technical and regulatory writing for GMP-compliant documentation.

• Ability to translate complex scientific processes into clear, structured, and submission-ready content.

• Skilled in document management systems (e.g., Veeva) and working within regulated environments.

• Strong attention to detail, version control, and content consistency.

• Excellent stakeholder engagement and communication skills across technical and regulatory functions.

• 1st Interview – With MSAT/Viral Vector and Regulatory stakeholders

• 2nd Interview – If needed with Quality or Technical Operations leadership

• Start Date: ASAP
  
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