NL - Analyst/Technical Expert for Equipment at Bioassay

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Janssen Biologics is currently recruiting an Analyst/Technical Expert (Coordination role) within our One JSC Lab department to strengthen our team. The successful candidate will have a background in the industry as well as a relevant academic background.

About the Company:

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, hardworking, passionate and multi-scaled people are working in a multifaceted culture in which innovation and a 'can do' state of mind are the central points.

Janssen Biologics is an important player in the biopharmaceutical industry. We develop, produce and sell medicines. Our dedication and high-quality standards bring innovative treatments - and hope- to patients all over the World!

The department:

As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Bioassay test team is responsible for execution of test methods using various biological techniques (e.g. ELISA, PCR, Cell Culture, Bioassays). Samples ranging from early clinical up to commercial process control, release and stability.

The job:

For our team, we are looking for an Analyst/technical Expert.

You will actively handle the quality and compliance related issues especially related to equipment (Pipetting robot (TECAN), plate-reader etc.). Act as Subject Matter Expert (SME) during cGMP inspections and are responsible in planning and implementing these tools. You will have to create and maintain a long term (financial) plan for the equipment. Bring in new technologies and are responsible for automating of some of the pipetting work. You will be part of our team to maintain cGMP compliance and LEAN status of the team.

The key responsibilities of the jobholder:

1. Equipment and new technology

• The job holder coordinates activities related to equipment qualification and maintenance
• You are generating a long-term plan to meet future needs on required equipment (including financial plan) and follow up with stakeholders, making sure there is enough place and equipment to test future needs and that the lab lay-out is efficient to work in.
• The job holder is responsible for coordinating TECAN (pipetting robot) activities, making sure new scripts are being qualified and TECAN is most efficiently used.
• The job holder is responsible for setting-up URS’s (user requirement settings) in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
• You are connecting and scouting new technologies that could benefit the department. Checking and designing how the new technology could be implemented in the department within the GMP environment.
• Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines.
• The jobholder is responsible for ensuring that assays can technically be carried out by the departments concerned in a manner that is efficient, adheres to cGMP and is safe. This could be accomplished by means of the GAP analysis performed during the new product implementation.
• Leads and drives continuous improvement processes.
• iLabs roll out in 2022 – coordination of digitalization of ASSAY run sheets in eLIMS (nice to have)

2. Deviation Management

• The jobholder is responsible for deviation management within the Bioassay team. This includes, but is not limited to:
• Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions.
• Supervise timely closure of medium/high-level investigations and associated CPA’s.
• Supporting and advising other lead investigators from external and internal QC departments.
• Accurate lab investigation and CPA’s for the medium/high-level Quality issues.

Job requirements:

• Good technical writing skill in English
• Knowledge of statistical data analyses
• Knowledge on equipment introduction
• Organizational skills in order to optimally coordinate a project, project management skills
• Experience in a GMP lab is a plus
• Experience with TECAN would be a great plus
• Onsite in Leiden, remote work possible (max. 2 days)
• 100% or 80% FTE
• Relevant work experience min. 5 years
• Assignment for 12 months

EXTRA INFORMATION:

• This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).