Scientific Director Release Sciences / Leiden

Organisatie: Johnson & Johnson
Locatie: Leiden
Functie: Scientific Director Release Sciences
Vervaldatum: 25/06/2021
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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 Release Sciences you are the scientific lead accountable for overseeing all release data related to platform and the testing strategies of our adenoviral vector-based vaccine platform. You provide content knowledge for the platform testing strategies and are driving improvements to this platform. You 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 Release Sciences has a key role and is very visible both within as outside the department. He or she is involved in all aspects of the release, stability and characterization testing strategies of our adenoviral vector-based platform and has interactions with various functionsand senior management. The role has the following responsibilities and duties:

  • Maintain and improve platform testing strategies linked to platform quality attributes and control strategy including what not to test (in collaboration with others within and outside the Analytical Development Department (Analytical Integrators, Product Characterization team, Method Development teams, Drug Substance and Drug Product Development, CMC teams, Subject Matter Experts). Present this in CMC project teams and to senior management of Janssen Vaccines.
  • Up-to-date with regulatory guidance on requirements for vaccine product testing (incl. characterization) and share this knowledge
  • Maintain overview of questions and requests from regulatory agencies on the platform release testing strategy and lead the development of mitigation strategies
  • Lead identification, implementation and specification definition (incl. justification) of new testing opportunities in the platform release package
  • Overseeing the release data of the adenoviral-based vaccines and develop strategies based on these data
  • Own platform specifications and justification for DS, DP, MVS, WVS (incl. IVP), inoculum
  • Contribute to definition of CQAs and overall CS
  • Justification of specifications and of ‘what not to test’ (release and EOSL): for platform CQAs
  • Review of regulatory submission (IND/IMPD/Briefing books/MAA/BLA)
  • Qualifications

    Requirements

    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:

  • Biopharmaceutical product testing and characterization
  • Knowledge of the regulatory guidance
  • 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
  • Scientific attitude
  • 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.

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