Berlin, Berlin, Germany
Senior downstream process development scientist with 6 years’ of CMC work experience in the biopharma industry. Experienced in preclinical process development and process transfer. Sound knowledge of pre-BLA/MAA development activities (i.e. risk assessments, process characterisation, process validation) as detailed in ICH Q11.
Performing risk assessments (FMEA) in support of customer's BLA programs. Managing and overseeing multivariate process characterization studies to support validation of biopharmaceutical manufacturing processes. Analysis of outputs using 'Design of Experiment' software. Authoring/ reviewing source documents to support regulatory dossiers.
Development of downstream processes for biopharmaceuticals, suitable for transfer to pilot and manufacturing scale; conducting process evaluation and characterisation studies; working as part of a project team to address customers' needs.
Post master assignment (international intern) in upstream process development for biopharmaceuticals; close collaboration with downstream processing, analytic development and expression technology; participation in technical development team meetings; operation of fed- batch and perfusion bioreactors of varying scale; cell culture work; design and execution of fed- batch experiments to study the effect of different feeding strategies on product quantity and quality; operating standard analytical equipment; drafting SOPs; some insights into GMP clinical manufacturing
Completion of Master’s thesis with subsequent assignment to support process development; acquisition of fundamental methods in downstream processing of biopharmaceuticals (e.g. IEX, HIC, affinity, SEC); method programming in UNICORN and operation of ÄKTA systems; development of an automated procedure for multi-cycling membrane adsorbers, Support of non-GMP pilot scale purification activities