Indien solliciteer direct u verwijst naar een ongeldig webadres, is de vacature waarschijnlijk inmiddels vervuld.
Attendeer FMF hierop
Head of Technical Integrators
Director Drug Product Development Technical Integrators Team
The DPD department develops the bulk drug substance and drug product formulations, the aseptic compounding and fill/finish processes (Leiden, The Netherlands).
Het bedrijf / The company
DPD manufactures DP in de internal Fill/Finish facility in Bern (Switzerland) and oversees DP manufacturing at Fill/Finish sites outside Janssen (Leiden, The Netherlands).
The department is embedded in the broader Vaccine Process & Analytical Development (VPAD) organization and collaborates with the clinical (supply) teams to define the storage and distribution network, and to generate in-use stability data.
The Drug Product Development (DPD) department consists of the five teams that work closely together: Formulation Development, DP Process Development, DP External Manufacturing, Formulation Science & Technology and Technical Integrators (TI).
Janssen Vaccines & Prevention BV (8852)
De functie / The role
As a director you will lead the Drug Product Development Technical Integrators Team (TI), covering the transition of vaccine candidates from discovery into early development until licensure and life cycle management.
The DPD TI’s are responsible for representing the DPD dept in the CMC-teams.
The TI leads a project specific DPD sub-team composed of representatives of all DPD functions.
You report to Head Drug Product Development and you are an active member of the DPD staff.
You demonstrate behaviors consistent with the J&J Leadership Imperatives (Connect, Shape and Grow) with at the center Our Credo and Our Purpose.
You manage the TI-team activities for the CMC project portfolio and for continuous improvement projects, balancing supply and demand budgets.
You drive cross functional and cross departmental cooperation
You set priorities within projects and between projects
You oversee all DPD activities within every CMC-team and actively participate in decision-making discussions at multiple levels
Define, execute and adapt the TI team strategy based on running and expected CMC projects, covering:
Prioritization within and between CMC projects
Weighed TI support for all projects
CMC and functional expectations
You connect and collaborate with other teams within DPD and the (VPAD) organization as well as with other organizations within JnJ.
Population of the functional planning in accordance with defined and agreed upon work packages per project.
Review of regulatory documents and active participation in regulatory meetings.
Cultivating internal and external relationships and partnerships.
Stimulate innovative problem solving and creation of Intellectual Property.
Employ people leader skills managing and improving team dynamics and supporting personal development of the different team members:
Coaches employees and is hands-on when needed.
Empowering of direct reports to act with speed, agility, and accountability
Supports a continuous improvement mindset.
Supports leadership trainings to enhance personal development and team dynamic.
Het profiel / Your profile
Education and Experience:
You are a connector, a bridge builder between projects and between the various participating functions within projects.
Capability to lead, develop, coach, motivate and monitor medium sized team of highly developed professionals.
Responsible for the growth and development of Technical Integrators to improve their role in the CMC and functional environment.
Excellent communication skills, both oral and written, as well as conflict management and negotiation skills.
Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
Self-starter, problem solving attitude, change manager, independent thinker.
You can make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions.
Excellent influencing skills. You can influence partners without line authority is required.
You are highly capable to distinguish between main and side issues.
A Master’s degree in life science or related field with at least 10 years of experience in pharmaceutical, biotechnology or related industry.
Extensive experience in early stage and late stage development of vaccines and preferably hands on experience in the field of DPD.
Demonstrated capability for strategy development and successful execution at the level of the DPD organization.
Demonstrated experience in overseeing (NDA) regulatory trajectories.
Demonstrated experience with matrix organizations.
Demonstrated capability for guiding operational excellence and other improvement trajectories.
Preferably CMC development experience and scientific knowledge of early and late stage DPD and Manufacturing.
Preferably experience with product launch and product launch capacities and infrastructures.
Role model for EHS, quality and compliance; proven risk manager.
Control of the English language at the highest level.
Het aanbod / The offer
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. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company.
You can be part of dynamic VPAD / Janssen Vaccines group where the vision is: “to establish a leadership position in transformational vaccines that are first and or best in class in areas of high unmet medical need”.