CMC Program Manager | 20 hours | 1 year
SIRE
Zuid-Holland, The Netherlands
11 uur geleden

The company

Our client is a professional organisation, based in Zuid-Holland Netherlands. This company is committed to developing first-

in-class or best-in-class vaccines for some of the world's most life-threatening infectious diseases. They have built a dedicated, world-

class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. They partner with many of the world's leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against.

Role description

You will provide support and represent the CMC Team. Translating the CMC strategy into realistic and executable CMC devlierables with clear assumptions based on CMC & Commercial input.

Responsible supporting risk management processes and specifically identifying and developing of mitigation strategies with the CMC Team.

You will work out scenarios to support decision making in line with CMC, New Product Team and CDT Strategy, managing the CMC end-

to-end process from pre-NME through launch.

Responsibilities

  • Proactively plan and manage the cross-functional project deliverables that support the CMC development and Commercial Launch
  • Work in close collaboration with the CMC Leader, New Product Team and Commercial Lead
  • Active follow-up on the progression of all CMC activities required to succesfully launch product
  • Monitoring CMC driven KPI's, decision points and critical path activities
  • Owning of the CMC schedule in V6, including : creation, monitoring and maintenance from pre-NME through launch.
  • Resource (FTE & OOP) and Budget Management in collaboration with Functional Planning and Program Coordinators
  • Identifying areas of need within the department and works to mitigate them
  • Outline new processes and support the integration of enabling technologies into the team setting to drive efficiency
  • Help ensuring organization readiness to support project execution (talent, training, e.g.)
  • Working together with line management to address gaps in current cross-departmental processes and organizational structures
  • Summary of the primary responsibilites :

  • Program and Strategic Planning
  • Operations management and Leadership
  • Product Development and Submission Management and Oversight aligned to customers
  • Program Information and Communication Management
  • Program Timeline, Resource and Cost Management
  • Requirements

  • Minimum Bachelors' degree in a pharmaceutical related field
  • Professional Project Management certification (e.g. PMP) is a plus
  • 8 / 10 years' of experience in the industry, including at least 4 / 6 years in a pharmaceutical company
  • Experience with CMC development
  • Experience in areas such as; Manufacturing, Active pharmaceutical ingredient, Drug Product Development, CMC Regulatory and Analytical Development
  • Working knowledge of Drug Development
  • Experience in developing a health authority dossier
  • Other information

    This position is for 20 hours a week

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.

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