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Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.
Interested ? Contact us !
This is a laboratory-based technical function at PhD or experienced graduate level requiring practical Ion Exchange Chromatography expertise aimed at process research & development, and scale-up activities.
Development and optimization of an in-depth understanding of the ion exchange chromatographic process relating to the postholder's projects and an awareness of the previous and next processing steps.
Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimental and/or scale-up studies using standard and specialised equipment and techniques (laboratory and Akta ion exchange workstation). Initiation, monitoring and work-up of experiments as well as isolation and purifications of materials (laboratory, kilo-lab and pilot scale).
Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality. Submission of materials for analysis and/or generation of analytical data using standard laboratory analyses. Interpretation of analytical results from these tests for laboratory and scale-up activities.
Ensuring good record keeping with respect to all laboratory, particularly regarding patentability & cGMP requirements.
Preparation of detailed reports covering specific work programs on completion of the activities or whenever appropriate.
Participation in the transfer of the processes from laboratory to production, under the direction of project leader.
Full compliance with all departmental and site-specific health, safety, environment and quality regulations, systems and procedures covering laboratory and scale-up activities. Additional requirement of full compliance with all business policies and guidelines.
Participation in and active contribution to departmental and/or technical meetings as required. Responsibility for ensuring compliance with action established during these meetings.
New PhD or master or a graduate with a minimum 3 years experience in a similar function in the pharmaceutical or fine chemical industry
Knowledge in the pharmaceutical chemical development and technologies
Proficiency with QBD development and data processing tools
Understanding of regulatory and GMP quality constraints
Demonstrated capacity to work in a matrix organisation in different technical areas
Demonstrated capacity for developing and managing projects with outsourced resources
Demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
Intermediate level in english
Key technical backgrounds : organic chemistry, chromatography (HPLC/UPLC/GC) and characterization techniques (UV; PAT; NMR and MS spectrometry), automatized equipment, typical lab equipment
Be able to find technical solutions and activate all appropriate internal / external experts to solve the issue
Be able to efficiently translate acquired data into knowledge answering the project needs
Must be able to independently manage scientific tasks in order to meet deadlines within given constraints in resources, e.g. heaadcounrt, equipment, time, etc
what do we offer?
Consutling mission until min. the end of the year.
We offer an attractive salary with extra-legal advantages :