CMC PROJECT MANAGER

BeerseIFarmaceutische industrie

Functieomschrijving

For our pharma client in the region of TURNHOUT we are looking for a CMC PROJECT MANAGER.
In this role, you will be part of the global CMC team of 40, with 15 based in Belgium. The focus of this role is the operational translation of CMC strategy.

As CMC Project Manager you will:

  • Provide CMC (Chemical Manufacturing & Control) Team Support and represent “CMC PM” at the PMT (Project Management Team)
  • Translate the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input
  • Support risk management process, specifically identification and development of mitigation strategies with CMC team & PMT
  • Work out scenarios to support decision making in line with CMC, JSC (Janssen Supply Chain) and CDT (Compound Development Team) 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:
    • Works in close collaboration with the CMC Leader, SI’s (Scientific Integrators), JSC New Product Team(NPT) and Commercial Lead
    • Active follow-up on the progression of all CMC activities required to successfully launch product
    • Monitor CMC driven key milestones, decision points and critical path activities
  • 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
  • Represent CMC and JSC at the PMT
  • 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 identifiy 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.)
Profiel
  • You have a Master, MBA or PhD in a pharmaceutical-related area
  • Professional project management certification (eg, PMP) or degree is a plus.
  • You possess 8 to 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


Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Aanbod You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.
Heb je nog vragen?
Marlies Collart Human capital developer Select Projects +32 3 203 50 80
CMC PROJECT MANAGER Vacature informatie
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