In your role as CMC project manager you are responsible for Program and Strategic Planning, Operations Management and Leadership, Product development & Submission Management and Oversight alignment to customers. Also Program Information/Communication Management, Program Timelines, Resources, ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a CMC Project Manager.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
In your role as CMC project manager you are responsible for Program and Strategic Planning, Operations Management and Leadership, Product development & Submission Management and Oversight alignment to customers. Also Program Information/Communication Management, Program Timelines, Resources, and Cost Management will be part of your daily tasks.
- Provide CMC Team Support and represent “CMC PM” at the PMT Team;
- Translate the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input;
- Support risk management process;
- Work out scenarios to support decision making in line with CMC, JSC and CDT strategy;
- Manage the CMC end-to-end process from pre-NME through launch;
- Proactively plan and manage the cross-functional project deliverables that support the CMC development and Commercial Launch;
- Active follow-up on the progression of all CMC activities required to successfully launch product;
- Own 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
- Work in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the CMC strategy with the CDT strategy;
- Work in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the CMC strategy;
- Proactively identify 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.
Who we're looking for
We are looking for an experienced candidate with a background in pharmaceuticals or life sciences. You have at least 8-10 years relevant work experience including 4-6 years in the pharmaceutical industry. Experience in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory and/or analytical development is required. Experience with developing dossiers for health authorities as well as Professional Project Management certification (e.g.. PMP) is a plus.
Are you the experienced CMC project manager we are looking for?
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Fixed-term assignment for 1 year with possible extension of 6 months. 16 - 20 hours per week
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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