Janssen Vaccines & Prevention B.V., previously Crucell, 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 to protect people worldwide from infectious diseases.
In the Analytical Development (AD) Department, we are responsible for the development, validation and transfer of methods for QC release and stability testing, and product and process characterization of our Vaccine products. In addition, AD leads shelf-life determination, setting specifications and defining product control strategies and is accountable for product comparability assessments. With the licensure of several vaccines, support of the commercial organization is a new task for the AD department. These responsibilities include life cycle management of methods, supporting process or manufacturing site changes, leading product specifications, shelf-life updates, regulatory submissions to rest of world countries and supporting method (including those running at national control laboratories) and product investigations. The Commercial Analytical Integrators are accountable for these activities. These project managers are interacting with the commercial as well as the development organization and are the single AD point of contact for Janssen Supply Chain (JSC) and CMC regulatory affairs (CMC-RA) post approval. This role requires a combination of project management skills combined with a strong scientific knowledge and ensuring scientific consistency.
Because this is a new activity for Janssen Vaccines, the roles and responsibilities and communications lines are being defined now and a lot of shaping is required. We are searching a head for this new team that will play a leading role in the shaping. You will be reporting into the Head of the Analytical Integrators and are heading and setting up this team. The team is expected to grow in the coming years with increasing commercial activities and new vaccines being licensed; sustaining and improving the support to the commercial activities by the analytical department is required.Responsibilities and dutiesThe lead has the following responsibilities and duties:
People manager of commercial analytical integrators
Accountable for strategy/tactics related to commercial activities for which AD is responsible
Shape, maintain and optimize the interactions between the Janssen vaccine development and commercial supply and quality organizations
Accountable for strategy and content of rest of world regulatory submissions and health authority requests
Owns resource demand and budget estimates for post approval activities
Executes task of commercial analytical integrator for one of our licensed vaccine
The candidate should have a confirmed experience of 5-10 years in a biopharmaceutical environment, have a broad understanding of functions involved in drug development, commercialization and after licensure. GMP and regulatory process experience is required. Vaccine or viral vector experience is a pre.Skills:
Assertive and pro-active with a can-do mentality
Strong personality able to build strong relations
Standout colleague and teammate
Excellent written and verbal communication skills
Confirmed project management skills and the ability to lead multidisciplinary teams of professionals
Organizational sensitivity and conflict resolution skills, able to build bridges
The candidate has preferably a masters/PhD in Chemistry, Pharmacy, or equivalent life sciences degree and speaks proficient English. The ability to speak Dutch is a plus.
We are looking forward to seeing your application.Primary Location