Scientist Process Development

Scientist Drug Product Process Development (m/f/x, 100%) Role: Permanent Business Unit: Vaccines Location: Leiden, Netherlands; other locations in Europe can be considered 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 infectious diseases. Besides the activities to develop and transfer the Corona vaccine, 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. The Process Development group within the Drug Product Development department focuses on the 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 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 groundbreaking development and bring life threatening diseases to a halt? In this position, you will be working in an outstanding team to develop drug product manufacturing processes and technology transfer of innovative vaccines. The main responsibilities are to: Setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data Establish and maintain trustful and professional relationships with internal and external stakeholders Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level This role involves up to 5% of international travel Qualifications Requirements: MSc degree in biopharmaceutical sciences, biotechnology or related fields. Ph.D. degree preferred A minimum of 2 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 development and optimization Competences: Passion, initiative and creativity joined with a scientific and quality attitude Strong work ethic, organized and structured demeanor Learning agility with ability to quickly assimilate and digest information; strong analytical skills Flexible team member with positive demeanor. Ability to work on his/her own in a complex matrix environment and deliver on projects with “can do!” attitude Proven project management skills. Ability to manage and prioritize multiple projects within a changing environment Excellent written, verbal, and interpersonal communication skills, with strong presentation style at all levels of the organization Excellent command of 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. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability Primary Location Netherlands-South Holland-Leiden- Organization Janssen Vaccines & Prevention BV (8852) Job Function R&D Requisition ID 2105984093W