J&J Family of Companies Director Stability Sciences in Leiden, Netherlands
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 and validation of methods for QC release and stability testing, and product and process characterization of our Vaccine products. In addition, AD leads setting specifications and defining product control strategies and is accountable for product comparability. As (Associate) Scientific Director Stability Science you are the scientific lead accountable for overseeing all data related to the stability of our vaccines ultimately leading to the shelf life claims and release and shelf life specifications for potency. You provide content knowledge for the projects and for that will work closely together with the Analytical Development project managers (Integrators) for the various vaccine development projects and other functions within and outside AD and are reporting into the Head of the Analytical Integrators.
Responsibilities and duties
The Scientific Lead Stability Science has a key role and is very visible both within as outside the AD department. He or she is involved in all aspects of the stability claims during the development of a candidate vaccine and has interactions with various functions and senior management. The role has the following responsibilities and duties:
Defining science and risk-based (lean) stability strategies and shelf-life models.
Collect, compile and use product stability knowledge and understanding (with many groups/departments involved, e.g. Drug Substance and Product Development, Product Stability team, Product Characterization and Comparability team, CMC team, method development teams)
Up-to-date with literature and regulatory guidance on stability and shelf-life models and share this knowledge
Provide scientific support for setting and justifying and what not to test (release and end of shelf life): for non-platform Critical Quality Attributes (CQA) related to product stability (content and potency)
Leading teams for stability strategies and shelf-life models for the various projects
Review stability sections and characterization sections in regulatory dossiers
Contribute to the definition of CQAs and overall CS
Presentations to senior management of the organization
Stakeholder management (on stability science)
Review suitability of analytical methods for stability study purposes.
The candidate should have scientific attitude, a proven experience of 5-10 years in a biopharmaceutical drug development environment, and broad understanding of functions involved in drug development/commercialization process, GMP and regulatory process experience is required. In particular the following:
Experience with (ICH) stability studies and shelf life models
Knowledge of the regulatory guidance for stability and shelf life of bio-pharmaceuticals
Interactions with regulatory agencies (IND/IMPD, MAA/BLA, briefing documents, etc)
Vaccine or viral vector experience
The candidate should have the following skills:
Assertive and pro-active with a can-do mentality
Strong personality able to build strong relations
Standout colleague and team mate
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 master's/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.
Janssen Vaccines & Prevention BV (8852)