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Testing Coordinator (Sr. Ass. Scientist)

LocationLeiden, - None Specified -
Business SectorPharmaceutical
Contact email
Job ref26325
Publishedabout 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.