Project Manager CMC
SIRE
Antwerpen, Belgium
1 dag geleden

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation.

We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies.

By using highly advanced algorithms, we enable our team of Resource & Data Strategists to maintain the most advanced, detailed and complete Life Sciences network in Europe.

This big data enables us to work Reverse Recruitment : we first analyze the market in-depth before we go out to the market.

Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment , making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Antwerpen Belgium.

The Company

Our client is a global pharmaceutical company based in Flemish Brabant, Belgium. Their focus lies on discovering, developing and testing many injectables.

Role Description

You will provide CMC team support. In this, you translate the CMC strategy into realistic CMC deliverables. You will support risk management process, specifically identification and development of mitigation strategies with CMC team & PMT.

You will work in close collaboration with the CMC leader and other parties and will plan and manage the cross-functional project deliverables that support the CMC development and commercial launch.

Responsibilities

  • Manage the CMC end-to-end process from pre-NME through launch
  • Reseource (FTE & OOP) & Budget Management, in close partnership with Program Coordinators
  • Ensure alignment of strategies with the CMC strategy
  • Mitigate areas of need within the department
  • Outline new processes and supports the integration of enabling technologies
  • Work with line management to address gaps in current cross-departmental processes and organizational structures
  • Requirements

  • Advanced degree in a pharmaceutical-related, life sciences or business subject
  • 7+ years of experience in industry
  • 4-6 years of experience in pharmaceutical industry
  • Experience with CMC development is a must, supervisory experience is a plus
  • Experience in CMC regulatory and drug product development areas
  • Experience in developing a health authority dossier is a plus
  • Other information

    This role can be done through payrolling, making use of our partnership.

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

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