Company : Eurofins Location : Braine-l'Alleud Wallonia From : Talent BE
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support activities for pre-clinical, stability, Phase 1/2).Transferring knowledge on early phase drug product development projects to the Late Stage Bio DP Development Team.Building close collaboration with the Bio DP Tech Transfer and Manufacturing Team for the establishment of drug product processes and manufacturing of stability and clinical DP batches. Support the development and implementation of the systems and processes for the DP CMC development strategy within DPDMMajor responsibilities:
Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or others.Provide all appropriate support to drug product process development activities (e.g., extractable volume assessment, target fill volume assessment, compatibility assessments, clinical blinding)Provide support to ensure timely delivery of stability and clinical trials DP batches.Preparation of protocols and reports in relation to drug product development activities.Ensure capturing critical process data and allow appropriate analysis of processes.Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities.Ensure efficient knowledge transfer from early phase development to late phase development.QualificationsMaster degree in biochemistry or biotechnology or biology or analytical chemistry or any related fields.Minimum of 3 years of experience. Good interpersonal, verbal, and written communication skills with ability to balance multiple priorities.Fluent communication skills in English.
French is a plus.Well organized, flexible, meticulous, and rigorous, proactive, with a strong team spirit.Able to negotiate and work in a team since there will be significant contact with internal and external groups.Able to work in a multicultural environment.Additional InformationA full-time (40hours/week) Monday – Friday job.A Permanent contract with flexible working hours.
You can start between 7am - 9:
30am.Work in a fast growing international organization.Meal Vouchers 8 Euro/Working Day.Eco-Cheques +/ - 250 Euro/Year.DKV Hospitalization insurance.Additional 12 ADV days.A company well-being program targeting both mental and physical well-being.A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environmentPersonal development through learning on the job and additional trainings. Eurofins Braine-l'AlleudWallonia
