Testing Coordinator Analytical Development

CLS Services; Leiden; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Testing Coordinator Analytical Development in Leiden, Netherlands. The role involves coordinating GMP and non-GMP testing, ensuring compliance with quality standards, and collaborating with cross-functional teams. The ideal candidate has a BSc. in Life Sciences and 5-10 years of experience in a pharmaceutical setting. This position offers a dynamic work environment and opportunities for professional growth.

Qualifications

• At least 5–10 years of experience in a pharmaceutical environment.
• Experience in CMC preferred.
• Strong background in life sciences.

Responsibilities

• Coordinate GMP and non-GMP testing internally and at external CROs.
• Execute internal testing related to release and stability.
• Maintain compliance with GMP standards.

Skills

BSc.

CMC

GMP

Process Coordination

Outsourcing

LEAN

Education

BSc. in Life Sciences

Job description

Testing Coordinator Analytical Development

Join to apply for the Testing Coordinator Analytical Development role at CLS Services

Vacancy number: A2500061

Johnson & Johnson Innovative Medicine - Leiden (Nederland)

For our client, Johnson & Johnson Innovative Medicine, we are looking for a Testing Coordinator Analytical Development.

Keywords

• BSc.
• CMC, GMP
• Process Coordination
• Outsourcing
• LEAN

Profile

The testing coordinator will be responsible for coordinating all GMP and non-GMP testing, in‑house and outsourced, related to release and stability of the products in development, and characterization of the products. For release of batches this process is from requesting samples to reporting of the certificate of the Analysis (CoA). Additionally, you coordinate the execution of the stability studies of the batches. You will be the first point of contact for the relevant internal stakeholders such as production sites, project managers and (stability) scientists, and external stakeholders such as CRO’s and CMO’s. Compliance with quality standards (GMP) needs to be ensured in various processes and during regulatory inspections, internal and external GMP‑audits you can act as subject matter expert.

Responsibilities

• Coordination of GMP and non-GMP testing internally and at external CRO’s.
• Execution of all internal testing related to release, stability, (re)qualifications of RMCR and late‑stage product and process characterization.
• Inspection, release and change management of incoming production raw materials, laboratory chemicals and lab supplies.
• GMP Sample and Material management.
• Environmental and utility monitoring of the GMP production plant.
• GMP qualification and management of lab equipment and computerized systems.
• Maintain and develop GMP and non‑GMP data systems to ensure data integrity and efficient and fast data processing.
• GMP Compliance management.

Who we’re looking for

We are looking for a BSc. level candidate with a strong life sciences background and extensive experience, at least 5‑10 years, in a pharmaceutical environment. Preferably, you have experience within CMC. You excel at process coordination, compliance, and cross‑functional collaboration, translating complex input