Klik hier voor meer Informatie
Salaris: euro
Werkgever: Yacht
Locatie: Leiden
Adres: Leiden, Zuid Holland, 2312 KX
Postcode: 2312KX
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.
Leiden site Technical Operations (TO) manages the process technology platform strategy for the production of biotherapeutics and vaccines. They are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of their commercial production processes.
Functieomschrijving
Job Description
Yacht Life Sciences has a vacancy for an Associate Scientist Technical Operations to work at Janssen Biologics in Leiden.
As an Associate Scientist you are a member of the Technical Operations (TO) Team with the dedicated focus on:
1. New Product Introduction (NPI) / Life Cycle Management (LCM)
2. (Process) Validation
3. Process improvements
4. Standards and new technology deployment
Essential Job Duties and Responsibilities:
Contribute to LCM/New Technology Introduction for the Site:
- Act as Subject Matter Expert in upstream processes (USP) for commercial manufacturing of pharmaceutical proteins and vaccines
- Define (process) validation strategies.
- Write and review (process) validation protocols and reports
- Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements
- Ensure integration of the global standards into local production processes
- Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the TO organization
- Capable of supporting complex investigations and risk assessments
- Act as SME during internal and external audits and inspections
- Represent Leiden TO in global project teams.
Functie-eisen
Job requirements
- Bachelor or Master degree or equivalent in Science, Engineering and Technical Subjects
- >2 years of relevant work experience within a GMP regulated environment
- Knowledge of and experience in a scientific or technical core area. Building knowledge and expertise in other technical and business disciplines.
- Affinity with process (analytical) technology and digitalization of manufacturing
- Delivers local small projects, regional project work streams or departmental programs successfully under supervision. Selects applicable engineering/scientific tactics.
- Proposes project and/or program goals and tactics. Assists in defining objectives to achieve targets on a team and/or individual level.
- Experience with validation and with or good understanding of manufacturing processes (USP)
Arbeidsvoorwaarden
Terms of employment
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 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 benefit package in line with the seniority of the position (salary between 2800 and 3800 euro gross per 4 week period).