The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. They develop vaccines that are the first or best in their class and protect against some of the world's most life-threatening infectious diseases. The pathogens against which vaccines are developed include Ebola, Respiratory Syncytial Virus (RSV), Human Immunodeficiency Virus (HIV), Extra-intestinal Pathogenic E. coli (ExPEC), Methicillin-Resistant Staphylococcus Aureus (MRSA), polio and influenza.
Role descriptionAs Senior CMC Project Manager, your primary duties are:
- 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.
Responsibilities• Provide CMC Team Support and represent “CMC” at the 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 & Project Management
• Works out scenarios to support decision making in line with the company 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
• Owns the CMC 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 CMC and JSC at the PMT
• Works in close collaboration with stakeholders to allign strategies;
• Proactively identifies areas of need within the department and works to mitigate them
• Identifies, develop and implement best practices
• Proactively outlines new processes and supports the integratration 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
Requirements*A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences
* 5-10 years of industry/business experience, including experience 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.
Other informationSubmit your application before the 13th of November.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.