Johnson & Johnson Careers
CMC Program Manager (VPAD)
Requisition ID: 1905758556W
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.
The VPAD CMC Project Manager:
Is a member of and provides support to the CMC Team/s within the Vaccine Production and Analytical Development (VPAD) organization; represents “CMC” in the Project Management Team (PMT); can be an ad-hoc member of VPAD CMC sub-teams and Janssen Supply Chain (JSC) New Product Team (NPT) as assigned.
Translates the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input. Supports the risk management process, specifically identifying and developing mitigation strategies with CMC team & PMT. Works out scenarios to support decision making in line with CMC, JSC and Clinical Development Team (CDT) strategy. Manages the CMC end-to-end process from pre-NME through Launch.
Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch: works in close collaboration with the CMC Leader, Scientific Integrators, JSC New Product Team (NPT) and Commercial Lead. Actively follows up on the progression of all CMC activities required to successfully launch product; monitors CMC driven key milestones, decision points and critical path activities.
Owns the CMC schedule (Planisware), including creation, monitoring and maintenance from pre-NME through launch. Manages resources and budget in close partnership with Functional Planning and Program Coordinators. Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the CMC strategy with the CDT strategy. Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the CMC strategy.
Proactively identifies areas of need within the department and works to mitigate them. Identifies, develops and implements best practices related to CMC, PMT and NPT Teams. Proactively outlines new processes and supports the integration of enabling technologies into the team setting to drive efficiency. Helps ensure organizational readiness to support project execution (talent, training, etc.). Works with line management to address gaps in current cross-departmental processes and organizational structures.
Primary duties in brief:
Program and Strategic Planning
Operations Management and Leadership
Product development & Submission Management and Oversight aligned to customers
Program Information/Communication Management
Program Timeline, Resource, and Cost Management
EDUCATION AND REQUIREMENTS
- A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences,
- OR business subject expert with greater than 10 years relevant work experience.
- Professional project management certification (e.g., PMP) or degree is a plus.
- 8-10 years of industry/business experience, including at least 4-6 years in the pharmaceutical industry.
- Experience with CMC development is a must. Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development, etc.
- A working knowledge of drug development is required.
- Experience in developing a health authority dossier is a plus.
WHAT’S IN IT FOR YOU?
At Janssen, every colleague makes a vital difference. Our people take pride in improving people’s health around the world. Each day, they make life better by going for high quality and continuous innovation. While doing so, they get the chance to grow their competences and take initiatives.
All of this in an international, value-driven group that cares for the wellbeing of its people.
A group that contributes to the quality of life as a global partner in healthcare.
Janssen is at the forefront of a new era in total healthcare solutions.
Janssen Vaccines & Prevention BV (8852)