Testing Coordinator Analytical Development

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Johnson & Johnson Innovative Medicine we are searching for a Testing Coordinator Analytical Development.

Keywords

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

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.

Profile

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 into clear documentation and efficient processes.
Other qualifications:

• Minimum 5 years in process coordination and GMP compliance;
• Continuous improvement mindset (e.g., lean thinking);
• Experience with systems like eLIMS or Veeva Vault;
• Flexible, accurate, and able to prioritize effectively;
• Excellent English proficiency; Dutch is a strong plus.

Benefits

Salary: 52000 - 62000
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

UBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd">

Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.

<

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2500061)