Yacht Life Sciences has a vacancy for an Analyst within the Bioassay team of Janssen Biologics in Leiden.
For the Bioassay team, we are looking for an Analyst that will active handle the quality and compliance related issues, including medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls. 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:
1. Data analysis
The jobholder is responsible for deviation management within the Bioassay team. This includes, but is not limited to:
- 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 stakeholders (other sites, DPDS)
- Analyze and update capacity planning including calculated hours required for performance of the different assays.
2. Deviation Management
- 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.
- Supporting and advising other lead investigators from external and internal QC departments.
- The job holder is responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues.
- Monitor timely closure of medium/high-level investigations and associated CRA’s.
3. Lab Execution
- The jobholder is responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. This could be accomplished by means of the GAP analysis performed during the new product implementation.
- The jobholder server as Bioassay expert and will be requested to represent the team during internal/external meetings. The jobholder will act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
- The job holder is responsible for creating URS’s in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
- 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.
- Bachelor or Master degree in a relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry
- > 2 years of relevant working experience in a (bio) pharmacy.
- Good technical writing skill in English
- Good knowledge of statistical data analyses
- Experience with deviation management
- Didactical skills in order to effectively transfer information in a training environment
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated). Full time preferred, 32 hours discussable. Salary between 3000 and 4000 euro gross per 4 week period.
We will offer a competitive benefit package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
Janssen Biologics is an important player in the biopharmaceutical industry. Tehy develop, produce and sell medicines. Tehir dedication and high-quality standards bring innovative treatments - and new 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.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.