Location
Canton de Braine | France
Job description
Company Description
Eurofins is Testing for Life. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing, and in discovery pharmacology, forensics, advanced material sciences and agro-science Contract Research services. Eurofins is also a market leader in certain testing and laboratory services for genomics, and in the support of clinical studies, as well as in Biopharma Contract Development and Manufacturing. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. With 58, 000 staff across a network of 900 laboratories in 54 countries, Eurofins' companies offer a portfolio of over 200, 000 analytical methods. Eurofins Shares are listed on Euronext Paris Stock Exchange.
Eurofins Professional Scientific Services (PSS) is a global, award-winning insourcing solution. A Eurofins PSS employs and manages full-time analysts, technicians, scientists, and technical support personnel directly at the client facility to provide long term staffing needs while maintaining the same services, expertise, and cGMP compliance available at the Eurofins facility. Eurofins PSS offers excellent career opportunities for people who have a proven track recording in combining excellent technical ability with first class interpersonal and communication skills.
Job Description
Job Summary :
As a scientist working within the Biological Characterization and Pharmaceutical Development sciences departments, the hiring employee will BE providing :
- Technical support of biologics in the management/coordination in the establishment of robust, fit for purpose biologicals drug product manufacturing processes for early development phases.
- Supporting activities for defining and selecting drug product manufacturing processes and components for support to clinical manufacture (for early stage projects, e.g. 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 DPDM
Major 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.
Qualifications
- Master 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 Information
- A 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 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 environment
- Personal development through learning on the job and additional trainings.
Job tags
Salary
