CMC Scientist

West-Vlaanderen - Belgium - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Master

Feel free to contact

Elke Binst, Account manager

Apply now

About this role

  • The development and execution of sound strategies for manufacturing of vaccines
  • Vendor Management: Interact with contract manufacturing organizations (CMOs) to complete preclinical, IND-enabling and Phase I activities. Ensure vendors stay on-task and complete contracted work in a timely manner. Integrate deliverables and dependencies between vendors seamlessly.
  • All aspects of drug substance and product, including development and manufacturing: process development, scale-up, transfer, characterization, validation; analytical method development, qualification/validation; formulation, fill-finish; testing and release; review and approval of documents.
  • Project management: coordination of internal functions and external parties to establish contracts, budgets, sourcing of critical materials and supply of product candidates to clinical sites.
  • Format, edit, coordinate, and review regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions. You will compile documentation for submissions to the EMA and to foreign regulatory agencies and maintain regulatory documentation.
  • Coordinate with other departments to collect information for use in regulatory submissions
  • Proactive identification of problems/risks/issues and facilitate issue resolution and risk mitigation

About you

  • You have a PhD in the life or physical sciences, e.g. biochemistry, microbiology, biotechnology, chemistry, chemical engineering, etc.
  • 5+ years of relevant experience with a proven track record of successful CMC project management
  • Experience with outsourcing of manufacturing work to CMOs/CDMOs
  • QP support for quality agreements and release
  • Experience with cGMP and ICH regulations, working in a government regulated environment (EMA, FDA, FAGG, …)
  • Experience in the field of mRNA/vaccines will be considered as a strong advantage
  • Strong problem solving and project management skills with a proven ability to manage multiple projects and simplify/organize complex tasks

What we offer

Our network and expertise make it possible for us to advance your career. Brunel has a reputation of working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB300838
  • Location: West-Vlaanderen
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Master
  • Area of expertise: Project Management & Services
  • Closing date: Thursday, May 20, 2021
Apply now

Feel free to contact

EB

Elke Binst

Account manager Brunel Belgium Mechelen

+32 (0)15 27 33 33

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