Return to search results

Senior Process Engineer

Senior Process Engineer

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact nameCaitlin Girdwood
Contact email
Job ref24713
Published9 days ago

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

Responsibilities

  • 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