Scientist Upstream Process Development (USP)

Job description

Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team, we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden.

We are currently recruiting for a Scientist USP

Department/Project:

The Bacterial Vaccine Discovery department (BacVac) at Janssen Vaccines & Prevention is working on the discovery and early development of novel vaccines for bacterial infectious diseases. It strives to address unmet medical needs, such as bacteremia (sepsis), meningitis, and respiratory tract and nosocomial infections. P rojects at BacVac are primarily structured on scientific and technical collaboration with external biotechnology partners (governmental, academic, and industrial) that are innovative leaders in their field. This working process includes ‘state of the art' vaccine discovery, with subsequent in vivo evaluation of vaccine candidates in animal models for immunogenicity and/or efficacy. In addition, manufacturing processes are established and optimized, and the resulting clinical trial material is evaluated in human clinical studies.

The BacVac department has a diversified workforce, well equipped laboratories, and the possibility to acquire additional equipment and laboratory space. Janssen's support departments, such as Vaccine Process & Analytical Development (VPAD) and Quality Affairs (QA), provide expertise to BacVac and its external biotechnology partners, for the development of prototype vaccines. These external partners oversee some parts of the development of vaccine production processes in their own facilities. In addition, a significant portion of this development work is outsourced to contract research organizations (CROs), under BacVac's scientific leadership. Clinical trial material (CTM) is then produced for Phase I/IIa clinical studies in human, either at Janssen large-scale facilities, or via outsourcing to contract manufacturing organizations (CMOs).

Job description:

Janssen's Bacterial Vaccine Discovery department (BacVac) is recruiting a qualified scientist, to carry product development tasks (with a focus on bacterial fermentation), in support of major vaccine projects. In the course of his/her work, this specialist will be expected to work in coordination with scientists and process engineers within BacVac, with various Janssen support departments, and with external partners and contract organizations.

Your main responsibilities will be:

· Plan, execute/supervise, and evaluate bacterial fermentation experiments independently and systematically, for developing/improving, bacterial fermentation processes and primary recovery, as basis of vaccine upstream processing (USP).
· Develop strategies for scale-up/down and process control.
· Guide and train technicians/scientists on process development/troubleshooting efforts.
· Facilitate BacVac collaborations with contract research organizations (CROs) for outsourcing of USP experiments.
· Support technology transfer of USP processes from BacVac to large-scale development, either at Janssen large-scale facilities, or with help of contract manufacturing organizations (CMOs) under BacVac's supervision.
· Help organize scientific and technical documentation supporting development activities, in coordination with Janssen support departments and governance bodies.

Desired profile

Qualifications :

Education:

· M.Sc., Ph.D., engineer, or equivalent.

· Microbial Physiology, Biochemistry, or Biochemical Engineering

Experience:

·  Minimally two years of professional experience (large-scale vaccine development is a plus).
·  Expert knowledge in media design, feed development, scale-up, HTP screening, bioreactor control etc.
·  Hands-on experience with computerized lab scale bioreactor systems and relevant in-process analytical techniques
·  Deep mechanistic understanding of fermentation processes and a passion for scientific excellence is a pre-requisite
·  Deep scientific understanding of latest technological tools (e.g. Omics approaches) and their application for process development

Competences:

·  Problem solver.
·  Originates, and develops new project ideas and study plans.
·  Team player.
·  Leadership: able to help technicians/scientists manage and plan their work.
·  Focused on project goals (milestones and deliverables).
·  Communicates clearly and efficiently.
·  Maintains accurate written records.
·  Organizes data efficiently (databases), and with data security and integrity in mind.
·  Knowledge of DoE and relevant statistical/modeling tools
·  Knowledge of Good Manufacturing Practice (GMP) regulations and their implementation.
·  Knowledge of method qualification and validation (ICH guidelines).
·  Knowledge of scientific literature (including patents), with emphasis on bacterial vaccines.
·  Language skills: fluent English (other languages are a plus).
·  Computer skills (Excel, statistical analysis, databases, planning, etc.)

What's in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset.

We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility.

Through e-university, on the job training, various projects and programs, we ensure your personal growth.