Switzerland
In-depth knowledge of the biotech industry as ๐๐๐ง๐ข๐จ๐ซ ๐๐ซ๐จ๐ฃ๐๐๐ญ ๐๐๐ง๐๐ ๐๐ซ and ๐๐๐๐ก๐ง๐ข๐๐๐ฅ ๐๐ฑ๐ฉ๐๐ซ๐ญ in the development, optimisation, validation, technology transfer and registration of manufacturing processes for biological drug substances. Proven track record of successfully leading cross-functional multi-site project teams and interacting closely with external partners on early to late-stage and commercial projects. ๐๐ญ๐ฅ๐๐ง๐ฉ๐๐จ๐: โข Management of Biotech early to late-stage development and commercial manufacturing projects โข Development, technology transfer and scale-up of downstream (DSP) processes for recombinant proteins (Mabs, Fc fusion) โข Characterisation and Validation of drug substance manufacturing processes according to Quality by Design (QbD) principles โข Preparation of the CMC regulatory dossier for clinical and marketing applications worldwide โข Biosimilar development โข Collaboration with external partners including CMOs ๐๐๐ฎ ๐๐๐๐๐๐ซ๐๐ข๐๐ฃ๐ฉ๐จ: โข Led the validation at laboratory scale of the drug substance manufacturing process of a Biosimilar up to Process Performance Qualification (PPQ) within predefined timelines โข Developed the strategy and implemented a new approach to the process validation of a Biosimilar according to QbD principles that has since obtained a positive opinion for marketing authorisation from EMA โข Efficiently supported the preparation of the CMC dossier of a Biosimilar in collaboration with an external partner within predefined timelines for marketing submission to FDA to the full satisfaction of the customer
Leading drug substance process optimisation programs for a commercial Biological with the aim to increase productivity. Defining the strategy for product maintenance throughout its lifecycle both internally and at CMOs including industrial capacity plans. Support to regulatory submissions of the CMC dossier.
Management of planning, budget and risk reporting activities for a cross-functional multi-site CMC Biosimilar project in late-stage development and commercial phase in collaboration with an external partner as a CMO. Regulatory support to marketing applications of the CMC dossier of a Biosimilar worldwide in collaboration with an external partner, answer to information requests and submission of variations. Efficiently supported the preparation of the CMC dossier of the BLA submission within agreed timelines to the full satisfaction of the customer.
Led the development and validation at laboratory scale of the drug substance manufacturing process of therapeutic recombinant proteins for early to late-stage projects. Developed the strategy and implemented a new approach to the process validation at laboratory scale of the drug substance manufacturing process of a Biosimilar according to Quality by Design principles. Validation was completed up to Process Performance Qualification within predefined timelines agreed with an external partner and has since obtained marketing authorisation from both EMA and FDA. Technology transfer and scale up from laboratory to large scale manufacturing of several biological processes both internally and in collaboration with external partners.
Development of downstream manufacturing processes for recombinant proteins expressed in mammalian cells (Fc fusion, Mabs).
Humanisation of monoclonal antibodies using molecular biology techniques, cloning and transient expression in mammalian cells followed by purification and analysis of the humanised Mabs.
Development of downstream manufacturing processes for recombinant proteins and plamid DNA.
Protein purification and analysis of protein glycosylation.
Purification and analysis of recombinant proteins.