| Location | Leiden, - None Specified - |
|---|---|
| Business Sector | Pharmaceutical |
| Contact email | |
| Job ref | 26325 |
| Published | about 7 hours ago |
Job Role: Testing Coordinator (Sr. Ass. Scientist), Analytical Development
About the Role:
We are seeking an experienced Testing Coordinator (Sr. Ass. Scientist) to join our Analytical Development team in Leiden, The Netherlands. This role focuses on coordinating all GMP and non-GMP testing, both in-house and outsourced, for release, stability, and characterization of products in development. You will act as a key contact for internal and external stakeholders, ensuring compliance with quality standards and supporting efficient, accurate, and timely testing processes.
Key Responsibilities:
Coordinate GMP and non-GMP testing internally and at external CROs.
Oversee execution of internal testing related to release, stability, (re)qualification of RMCR, and late-stage product/process characterization.
Manage inspection, release, and change control for production raw materials, lab chemicals, and lab supplies.
Handle GMP sample and material management.
Support environmental and utility monitoring of the GMP production plant.
Manage GMP qualification of laboratory equipment and computerized systems.
Maintain and develop GMP and non-GMP data systems to ensure data integrity and efficient data processing.
Act as subject matter expert during regulatory inspections, internal audits, and external GMP audits.
Serve as first point of contact for internal stakeholders (production sites, project managers, stability scientists) and external partners (CROs, CMOs).
Key Competencies:
Strong knowledge of GMP regulations, CMC processes, and laboratory/compliance management systems (e.g., eLims, Veeva Vault).
Excellent cross-functional collaboration, communication, and interpersonal skills.
Ability to prioritize work effectively and handle multiple projects simultaneously.
Continuous improvement mindset (e.g., lean thinking).
Strong attention to detail and problem-solving skills.
Ability to maintain confidentiality and act with integrity.
Requirements:
HBO-level degree in a life science discipline.
5–10 years of experience in a pharmaceutical environment, preferably within CMC.
At least 5 years of relevant experience in process coordination.
At least 5 years of GMP experience.
Highly proficient in spoken and written English; Dutch is a strong plus.
Practical Information:
Location: Leiden, The Netherlands
Duration: 1-year contract
Start Date: ASAP
Work Model: On-site
Interested or know someone who might be?
Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.