CMC Scientist


Vrouw in labo

Over deze funtie

  • Markt: Life Sciences
  • Branche: Pharmacie
  • Expertisegebied: Project Management & Services
  • Standplaats: West-Vlaanderen

Wat is vereist?

  • Uren per week: 40
  • Opleidingsniveau: Academic Master
  • Sluitingsdatum: donderdag 20 mei 2021

Over deze functie

  • 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

Over jou

  • 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

Wat wij je bieden

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.

Start je sollicitatie hier!

Solliciteren bij Brunel gaat snel en gemakkelijk. Wij ontvangen graag het volgende van jou:

  • Recent CV of LinkedIn-profiel
  • Motivatiebrief (optioneel)
  • Certificaten (optioneel)
  • Referenties (optioneel)

Vragen over de vacature?

Jouw Talent Hunter, Elke Binst licht graag alles toe over deze vacature. Wanneer je contact opneemt, verwijs naar het volgende vacaturenummer:

Talent Hunter

Elke Binst
Brunel Belgium Mechelen

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