You will head and/or collaborate with a team of research associates and scientists and will be responsible for the planning, coordination, follow-up and reporting of assigned project activities. You will be responsible for the research approach and results of an intradepartmental team within the scope of assigned project activities. You will drive the recruitment of team members, training, development and performance management.
You should have hands on experience with state-of-the-art USP equipment such as Sartorius ambr 250 system or other types of benchtop bioreactors and stainless-steel bioreactors including harvest and clarification methods. Have a good knowledge of various analytical methods such as (U)HPLC, SEC, UV- and fluorescence spectroscopy, SDS-PAGE, HCP and endotoxin testing, ELISA… Knowledge of software packages implemented during USP development such as Sartorius MFCSwin or similar packages for control and data acquisition, LIMS, statistical analysis software such as JMP, SAS, multivariate statistics, DOE and experience with quality by design. You will collaborate in the smooth transfer of the USP technology and accompanying analytical methods from Ablynx development labs to the CMOs. You will be involved in all stages of pharmaceutical development up to life cycle management and critical reagent management.
You should have experience in project management, quality assurance, risk management, process characterization studies, knowledge of regulatory guidelines, GMP & Process Validation. You are experienced in controlling the quality and consistency of biopharmaceutical productions at least at the USP level (microbial and/or mammalian) and assisted in the development of large-scale manufacturing processes. You are experienced in cGMP production processes and in regulatory approvals and adherence with current quality requirements.
You will report about the results and progress to the line manager, project team, project leader and/or external parties in a clear and concise manner. Provides strategic guidance where needed. You will prepare high level reports, summaries, manuscripts and other documents as appropriate.
The candidate should: