Senior Process Engineer Leiden • Panda International

An international biopharmaceutical company is seeking a Senior Process Engineer (Drug Product Development) for a 6-month contract to support the development and lifecycle management of CAR-T drug products. Based in Leiden, Netherlands, this role is key to advancing fill-finish process development and supporting commercialization through strong technical and regulatory leadership.

Key Details:

• Start Date: ASAP

• Contract Duration: 6 months

• Location: Leiden, Netherlands (Onsite/Hybrid)

• Languages: English required

• Interviews: Flexible & fast process

• Fill-Finish Process Development – Drive the development of robust, scalable, and GMP-compliant fill-finish processes for CAR-T drug products.

• Stability Studies – Define and execute ICH and in-use stability studies, ensuring product consistency and regulatory alignment.

• Container Closure Qualification – Lead the qualification of container closure systems, ensuring compatibility and integrity.

• Extractables & Leachables (E&L) – Manage E&L studies, ensuring product safety and compliance with regulatory expectations.

• Tech Transfer & Lifecycle Support – Provide technical leadership in the tech transfer of drug product processes across manufacturing sites globally.

• Documentation & Regulatory Support –

• Author and review process documentation, SOPs, risk assessments, and regulatory content.

• Contribute to regulatory filings and respond to health authority queries with technical insight.

• Cross-Functional Collaboration – Work closely with MSAT, Manufacturing, Regulatory Affairs, and Quality to ensure product readiness.

  
  Requirements
  

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

  • Proven experience in cell & gene therapy, drug product development, formulation, stability, GMP manufacturing, and tech transfer.

  • Strong knowledge of regulatory requirements and process validation.

  • Experience with data management and statistical process controls is a plus.

  • Excellent communication and cross-functional collaboration skills.

  • Self-driven, quality-focused, and comfortable navigating shifting priorities.

  • Fluent in English (written and spoken).

  Why This Role?
  

  • Cutting-Edge Science – Be part of a global team developing transformational CAR-T therapies.

  • High-Impact Work – Contribute to the successful commercialization of life-changing treatments.

  • Global Scope – Collaborate across international sites and functional teams.

  Interview Process
  

  • 1st Interview – With Hiring Manager & Project Stakeholders

  • 2nd Interview – If required

  • Quick Decision Process – Flexible scheduling