Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
1 - 2 Years
Analyst/Technical Expert Bioassay Team
Janssen Biologics is currently recruiting an Analyst/Technical Expert within our One JSC Lab department to strengthen our team. The successful candidate will have a background in the biologics/pharmaceutical/manufacturing 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.
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, qPCR, Cell Culture), samples coming from all over the world, ranging from large molecule pharma to vaccines to medical devices.
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 Bioassay department is responsible for testing various samples ranging from early clinical up to commercial process control, release and stability using different methods and techniques e.g. ELISA, qPCR, Cell Culture.
For our team, we are looking for an Analyst/technical Expert.
You will actively handle the quality and compliance related issues, including low, medium and high-level deviations, CAPA, assessments. To maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Expert (SME) during cGMP inspections and is New Product Introductions (NPI) contact person during the new product implementation process.
The key responsibilities of the jobholder:
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.
Monitor 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.
2. Lab Execution
The job holder coordinates activities related to NPI introductions.
The jobholder is responsible for ensuring that assays can technically be executed 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.
The job holder is responsible for crafting URS’s in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
The jobholder is responsible for data gathering for assay performance, including raw data. Analyze the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different teams (other sites, DPDS)
Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines.
Leads and drives continuous improvement processes.
Good technical writing skill in English
Knowledge of statistical data analyses
Didactical skills to effectively transfer information in a training environment
Organizational skills in order to effectively coordinate a project
Minimum of 2 years of experience working in a GMP lab
Minimum of 2 years of experience with biological assays
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies