Yacht Life Sciences has a vacancy for a Scientist Drug Product Process Development at Janssen Vaccines & Prevention in Leiden, the Netherlands.
The Process Development group within the Drug Product Development department is responsible for early- and late-stage process development activities in drug product manufacturing. The developed manufacturing processes are transferred to external GMP production facilities to produce clinical batches, as well as for scaled-up process validation/ verification and commercial manufacturing. This is done in close collaboration with both internal and external partners. Would you like to be part of this team to contribute to groundbreaking development and bring life-threatening diseases to a halt?
In this position, you will be working in an outstanding team to develop fill/finish processes and technology transfer of innovative vaccines.
Your main responsibilities are to:
· Establish and maintain a trustful and professional relationship with the stakeholders from departments within the company as well as with external partners;
· Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
· Setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally.
· Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level.
· MSc or PhD degree in biopharmaceutical sciences, biotechnology or related fields
· A proven work experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers
· Proven experience with regulatory submission writing and/or technology transfer for drug product (vaccines)
· The candidate could have experience with one of the two above and in best case experience with both regulatory submission writing and technology transfer for drug product (focus on vaccines)
- You work with passion and demonstrate strong leadership and initiative
- You can analyze problems on a high level
- You have a critical demeanour and an amazing scientific and quality attitude
- You have a strong work ethic, are resilient to change and are creative
- Good communication and interpersonal skills with stakeholders
- Project management skills
- Excellent written and oral communication skills in English
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 full-time secondment contract for 1 year (extension is anticipated). Full time is highly preferred, 32/36 hours discussable.
We will offer a competitive benefits package in line with the seniority of the position (salary between 4000 and 5400 euro gross per 4 weeks).
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.
About the company:
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases.
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.