Sr. Lab Technician

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Johnson & Johnson Innovative Medicine is recruiting for a senior Lab technician, Advanced Therapeutics, Analytical Development, located in Leiden, The Netherlands.

Sr. Lab Technician

The Strategic Operations (SO) group within the Analytical Development (AD) Department of the Advanced Therapeutics AD sector of J&J Innovative medicine.

The Strategic Operations group focuses on supporting production and laboratory activities with:

Inspection, release and change management of incoming production raw materials and laboratory chemicals.

Sample and Material receipt, handling, storage and forwarding.

Maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs.

Coordination of Release and Stability testing and Outsourcing Coordination.

Internal release and stability testing (incl. culturing of cells).

Provides Process Analytical Support (PAS) for Product Development teams.

Ensuring the availability and maintenance of qualified equipment used in the laboratories.

Based on formation plan and the needs within the SO organization, we are looking for a motivated senior Lab technician who enjoys working in a multidisciplinary environment and brings experience related to GMP compliance, and assay qualifications.

Main tasks for the Testing Operations team include, but is not limited to:

Release and Stability testing of GMP/TOX and clinical batches for Advanced Therapeutics products under GMP quality system.

Execution of Assay qualifications on GMP qualified laboratories.

Performing assays on a routine basis with a 'first time right attitude'.

Experience with analytical methods, like UPLC and HPLC.

Ensuring that a high level of Quality is maintained, based on previous experience working in a GMP environment.

Accurate completion of documentation such as digital assay run sheets, laboratory notebooks and equipment logbooks.

Support Process Development testing for Process Development.

Culturing of cells, including passaging and seeding of cells.

Write and update various documents (e.g. test instructions, work instructions).

Qualifications:

MBO (or HBO) level in a life science study.

Minimum of 5 years of experience in a GMP pharmaceutical environment.

Affinity with execution of assays under a GMP quality system is a must.

Experienced with assay qualifications/validations is a strong advantage.

Experienced with laboratory management systems.

Developed interpersonal skills and able to build strong relationships.

Flexible and accurate.

You are motivated and have a positive can-do mentality

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