- The executor of the development and evaluation for disposable bags mission works within the Device Development Team (New Product Development - TP Secondary - Device) in collaboration with GTS, PMCoE and QC departments by supervising/organizing/performing the laboratory experiments and providing protocols and reports describing the methodology and the results of the lab trials.
- The executor reports to the Scientist Delivery System of the Secondary Development Unit in New Product Development.
Role and main tasks:
- Working in a development lab and performing experiments for demonstrating the non-impact of plastic bag used for intermediate or final storage during formulation or filling operations on the life-cycle products (intermediate final bulk or final bulk.
Organizing the workload taking account the material (sampling of products in the Commercial facilities), the equipment (manage the prioritization with the other projects using same pieces of equipment) and the QC capability for samples analysis.
- Writing in English the protocols before starting the experiments and the reports summarizing the results in collaboration with Products and Process Experts.
Working in a development lab
- Working with other teams who share the same lab and equipment
- Fill correctly the raw data (lab books, etc.)
- Review and check the raw data (lab books, etc.)
- Knowledge of main characteristics of the studied products
- Knowledge of main characteristics of the plactic bags and disposable systems
- Knowledge of rehomogeneisation system
- Knowledge of aseptic experiments for avoiding contamination of products
- Coordination of the day-to-day workload with other lab technicians
- Cooperation with external departments such as Commercial facilities, QC, GTS and Products&Process Experts
- Update of a micro and a macro planning with key milestones
- Escalation of risks if milestones may not be respected
- Create tracking tables for experiments follow-up. Maintaining accurate and up-to-date information of the project.
Writing documentation (in English)
- Knowledge capture of the experiments
- Documentation management (templates, references, storage of data, etc.)
- Protocoles writing for each set of experiments/products describing the purpose of the
- trials and the methodology which will be followed
- Reports writing including the QC results and the signature of relevant people
- Engineer degree or scientific university degree
- Background knowledge of disposable system and interaction between the bag container and the Product
- Knowledge of lab work
- Knowledge of GMP rules
- Aseptic Notions
- Good communication skills
- Team spirit
- Well organized, eye for detail
- Stress resistant
- Motivated and dynamic personality
Language proficiency requirements :
- French: fluent
- English : business
- Dutch : conversational
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation.