Senior Scientist

il y a 1 semaine


MontSaintGuibert, Wallonie, Belgique Novadip Biosciences Temps plein

Responsibilities:

  • Design experiments, qualification, and validation strategy according to scientific and regulatory standards.
  • Autonomously organize and carry out the development, qualification, and validation of analytical methods for the characterization and quality control of investigational products.
  • Ensure scientific assistance to laboratory technicians in order to solve analytical issues on techniques run in the laboratory.
  • Participate in the identification of analytical methods and contribute to implementation of new technologies where appropriate.
  • Participate in the revision, validation and approval of analytical results and documentation (procedures, protocols, reports).
  • Carry out technological and regulatory surveillance (EMA, FDA, ICH).
  • Provide analytical expertise to projects.
  • Project management (timelines, results, budget) and present/discuss results in project team meetings.
  • Interact with QA and RA teams for file preparation and submission.

Profile:

  • Master's degree or PhD in relevant scientific discipline (e.g. Medical Science, Life Science Biochemistry)
  • At least 5 years of experience in the bio/pharmaceutical industry and/or GxP regulated laboratory is required.
  • Strong expertise in ATMPs analytical method development and validation is a plus.
  • Expertise in key analytical techniques for Biologics: immunoassays, bioassays, and QPCR is a plus.
  • Understanding of QbD principles applied to method development is a plus.
  • Strong and proven laboratory skills. High level of analytical troubleshooting needed for laboratory issues.
  • Knowledge of GLP, GMP and ICH standards.
  • Ability to handle multiple priorities, provide leadership and organization.
  • Excellent organizational and communication skills with the team and with external partners.
  • Fluent in French and English

Offer:

  • A fulltime permanent position (40h/week) in a growing team.
  • To work in a humansized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

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