Biotech and Agricultural Engineering Medical and Healthcare Other Science and Tech
3 - 5 Years
External Contract Laboratory Manager (Yacht Life Sciences)
Bedrijfsomschrijving About the company:
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility, where they produce vaccines against infectious diseases, such as HIV RSV. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandamic the VLF has been appointed as one of the production sites for Janssen’s lead vaccine candidate for COVID-19. Functieomschrijving
Yacht Life Sciences has a vacancy for an External Contract Laboratory (ECL) Manager at Janssen Biologics, situated in Leiden, the Netherlands.
In your role you will be accountable for one of the main laboratories which will test the COVID vaccine.
A suitable candidate will manage release and stability testing for the COVID vaccine.
Besides that, you will combine your experience in quality control testing with your talent for keeping clear overviews.
Good coordination skills will be needed to maintain the current processes; you should work together with other parties like External Manufacturing and Procurement to ensure all required assets are in place to enable efficient outsourcing and testing of the COVID vaccine.
Furthermore, you will work closely together with the External Quality group, the Analytical development department as well as with the QA department of different manufacturing sites.
Also, you will be responsible to ensure timely testing of the products.
Your Main Tasks and Responsibilities will be:
Keep clear overviews of different business processes
Set up and maintain planning and reporting tools
Ensure financial flows are managed
Ensure a standard process with standard governance structures and Roles and responsibilities is set up and maintained with the external laboratory
Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development or manufacturing
Manage all systems to be utilized to ensure test results are accessible in time for release and stability
Ensure timely and proper reporting to partners and stakeholders
Functie-eisen Job requirements are:
Finished Bachelor or Master
>8 years relevant experience (QC, release and stability testing) in a pharmaceutical environment
Good working knowledge of GMP
Experience with laboratory management systems
Experience with project management and governance structures
Knowledge about Outsourcing process within a pharmaceutical company is advantageous
Professional proficiency in English
Terms of employment:
This concerns a secondment contract via Yacht for 1 year. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with the seniority of the position (salary between 5500 and 7000 euro gross per 4-week period). 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 become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.