Senior Scientist - Mont-Saint-Guibert, België - Novadip Biosciences

Novadip Biosciences

Geverifieerd bedrijf

Mont-Saint-Guibert, België

2 dagen geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

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.