Bioanalytical Research Scientist

Il y a 6 mois


Brussels, Belgique Thermo Fisher Scientific Temps plein

**Bioanalytical Research Scientist - Belgium, Ghent**

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Thermo Fisher''s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

We are currently hiring for a **Bioanalytical Scientist** to join our client based in Belgium. The role will require 3 days on site in Ghent per week to support the implementation and execution of the bioanalytical strategies for the non-clinical and/or clinical development programs in tight collaboration with the project teams.

**Responsibilities**:

- As a bioanalytical study monitor you are responsible for the method transfer and validation to bioanalytical vendors and to keep oversight on BA study phases (GLP and GCP) of non-clinical/clinical studies, in close collaboration with the project team and the bioanalytical project manager
- Review of method validation plans and reports
- Review of bioanalytical sample analysis plans and reports of non-clinical and/or clinical studies
- Review and provide input in clinical trial related documents (protocol, reports, data transfer agreement, lab manual,..) as well as regulatory documents
- Supports the development of bioanalytical strategies in collaboration with bioanalytical, project team and clinical teams.
- Initiates and follows up on troubleshooting of bioanalytical methods
- Presenting results and findings at internal multidisciplinary project/clinical teams

**Profile**:

- Relevant advanced scientific degree (e.g. PhD, PD) or Master degree with extensive experience in the field of Life Sciences
- Experience in managing Contract Research Organizations (CROs) is considered an asset
- Good knowledge of bioanalytical techniques specifically in the field of biologics and antibodies
- Solid knowledge in the development and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP)
- Hands-on experience with ligand-binding bioanalytical methods on ELISA, MSD or Gyrolab is considered an asset
- Excellent interpersonal skills, enjoys working in multidisciplinary teams and with external parties
- Excellent organizational and communication skills
- Able to work independently
- Strong emphasis on quality
- Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.



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