Panda International
jobid=A.0.1735
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).
Interview Process
- 1st Interview – With Hiring Manager & Project Stakeholders
- 2nd Interview – If required
- Quick Decision Process – Flexible scheduling
Apply below to discuss further!
