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Sr Scientist Fill Finish Process Development
At Janssen Vaccines & Prevention B.V., part of Johnson & Johnson, we are dedicated to bringing meaningful innovation to global health. Our team focuses on the development of novel therapeutics and vaccines to treat, cure and prevent complex infectious diseases. The Corona pandemic has a huge impact on public life and the world economy. Besides Corona, these range from respiratory infections like Respiratory Syncytial Virus (RSV) to Human Immunodeficiency Virus (HIV) and pathogens of global concern such as Polio and Ebola.
Janssen Vaccines & Prevention BV (8852)
De functie / The role
The Fill/Finish 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 our team to contribute to this game changing development and bring life threatening diseases to a halt?
As Senior Scientist Fill/Finish Process Development you will be working in a multi-disciplinary team on the process development and technology transfer of several innovative vaccines and your main responsibilities are to:
Lead teams of motivated Fill/Finish process developers
Develop and execute Drug Product early- and late-stage process development and tech transfer strategies.
Establish and maintain a trustful and professional relationship with the different stakeholders from other departments within the company as well as with external partners
Act as senior author in the preparation of presentations, technical reports, documents for regulatory filing and patents
Besides these activities you:
Create and manage research plans with great complexity in the delivery of business results
Represent the Fill/Finish Process Development group in multidisciplinary project team(s)
Lead and participate in specialized committees, as appropriate to ensure continuous improvement on departmental and project level.
Het profiel / Your profile
Preferably a Ph.D. degree or MSc degree in biopharmaceutical sciences, biotechnology or related fields.
A minimum of 7 years of experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers.
Experience with two or more of the following: life cycle process validation; regulatory submission writing; technology transfer; process improvements.
You work with passion and demonstrate strong leadership and initiative
You can analyze problems on a high level
You have a critical attitude and a strong scientific and quality mindset
Our highly dynamic environment requires you to have a strong work ethic, be resilient to change and be creative.
Good communication and interpersonal skills with different stakeholders
Project management skills
Excellent written and oral communication skills in English
What we offer:
Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development trainings, projects and various programs, we ensure your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future.