For one of our clients, a pharmaceutical company in the area of Antwerp, we are looking for a CMC project manager.
Responsibilities
The CMC Project Manager:
- Provides CMC Team Support and represent “CMC PM” at the PMT 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, JSC and 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, 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 CMC schedule in V6, including creation, monitoring and maintenance from pre-NME through launch
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 CMC schedule in V6, including creation, monitoring and maintenance from pre-NME through launch
- Does resource (FTE & OOP) & Budget Management in close partnership with Functional Planning and Program Coordinators
- Represents CMC 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
- Identifies, develops and implements best practices related to CMC, PMT and NPT Teams
- Proactively outlines new processes and supports the integratration of enabling technologies into the team setting to drive efficiency
- Helps to 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
Requirements
- Minimum a bachelor degree, master, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject.
- More than 10 years relevant work experience.
- Professional project management certification (eg, 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 and 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.