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Clinical Project Manager

Via Pauwels Consulting

Pauwels Consulting is a Belgian consulting firm with more than 490 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Clinical Project Manager

Job description

  • Provide analytical expertise to specific activities including:
    • Update of  analytical methods
    • Change control
    • Write/update specifications
    • Troubleshooting in QC lab
    • Contacts with RA (analytical part in drafting dossiers for registration)
    • Write/update of stability supporting documentation
  • Support as needed specific projects: coordination of analytical activities and stability studies to support manufacturing process changes, review of CMO documentation, etc.

 

Profile

  • Master’s degree required in analytical chemistry (applied to biological products / NBE), biochemistry, biology
  • Analytical expert with experience (3  years+) in the pharmaceutical analysis (in QC, analytical development department or QA department supporting QC) of, preferably, New Biological Entities and more specifically monoclonal antibodies
  • Proven project leadership skills including planning, monitoring, issue resolution, decision making and reporting
  • Strong understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate)
  • Expertise in Regulatory Affairs and Quality applied to analytics is a plus
  • Experience in GMP is a must
  • Ability to manage interfaces with laboratory operations
  • Strong sense of accountability and responsibility, with the ability to manage priorities
  • Customer and results oriented
  • Key technical background:  chromatography (HPLC/UPLC); capillary electrophoresis, detection techniques (UV/Vis, MS), ELISA, USP, EP, and JP tests. Large molecule experience is preferred
  • Fluent in English (mandatory) and French (preferred)

Offer

  • Challenging projects based on your interests and skills 
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
This job is no longer available.

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Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time

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