Project Manager CMC
- Beerse, Antwerp
- Pharma & Biotech, Quality & Supply Chain, Clinical Research, Health Economics, Market Access, Medical Affairs, R&D, Quality Assurance, Regulatory Affairs, Datenmanagement und Biostatistik
Real staffing is currently looking for a Project manager to start as soon as possible a long term project in Beerse, for the company Janssen Pharmaceutica.
This is the perfect opportunity for an individual who likes working on a project mode, and interacting with different kind of profiles.
You will indeed work on different projects, with different CMC leaders and different CMC teams and you will be mainly of the planning of the activities and of the budget.
The job description could seem complicated to understand for someone who is not familiar with Janssen Pharmaceutica, but if you have the right skills, you will feel very comfortable after a few weeks in the company.
The Project Manager will: * Provide CMC (Chemical manufacturing Control) Team Support and represent "PDMS (Pharmaceutical Manufacturing Development Service) PM" at the PMT (Project management team). * Translates the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input * Supports risk management process, specifically identification and development of mitigation strategies with CMC team & PMT * Works out scenarios to support decision making in line with CMC, Supply Chain and CDT (Compound Development Team) strategy * Manages the CMC end-to-end process from pre-NME (New Molecular entity) 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, SI's, JSC New Product Team (NPT) and Commercial Lead
- Active follow-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 PDMS schedule in V6, including creation, monitoring and maintenance from pre-NME through launch * Resource (FTE & OOP) & Budget Management in close partnership with Functional Planning and Program Coordinators * Represent PDMS and JSC at the PMT * 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 * Identify, develop and implement best practices related to CMC, PMT and NPT Teams * Proactively outline new processes and supports the integratration of enabling technologies into the team setting to drive efficiency * Help ensure organizational readiness to support project execution (talent, training, etc.) * Work with line management to address gaps in current cross-departmental processes and organizational structures Primary Duties :
- 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
- Additional requirements may be identified specific for the level of CMC Leader/PML hired and/or for specific deployment considerations
- A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject.
- Professional project management certification (eg, PMP) or degree is a plus
- At least 7 years of industry/business experience, depending on level, including at least 4-6 years in the pharmaceutical industry.
- Experience with CMC development and is a must and supervisory experience is a plus
- 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.
- Long term contract
- Possibility to work from home 2 days/week
- Possibility to work as a freelancer or on the payroll of Real Staffing on a permanent basis, with all advantages offered to our employees
Should you be interested in this role, please apply today or contact Isabelle Leparlier on 02.610.59.00 for more information.