Switzerland
Biotechnology professional with a proven track record across mAb and non-mAb biologics, ADCs, peptides, mRNA, and gene therapy, and a deep understanding of the pharmaceutical and biotechnology industry. Leading teams and managing multiple projects, with effective prioritization and on time delivery of results. Experienced in problem solving to address complex scientific and operational challenges. Combines a pharmacy background with experience across academia, big pharma R&D, and manufacturing, enabling informed commercial and strategic decision making.
- Management of teams and projects to deliver multiple projects on time and within budget - Leading the design, development, process optimization, pilot scale, scale-up, and technology transfer of downstream processes for cGMP manufacturing. - CMC project management - planning, budgeting - Managing outsourced CDMO manufacturing and CRO projects. - Influencing strategic decisions within cross-functional teams to align priorities and achieve project success. - Interaction with stakeholders and management, promoted KBI capabilities, and collaborated with BD and PMO to support project acquisition and business continuity. - Understanding of cGMP requirements and regulatory standarts. - cGMP investigation, drug substance process improvement, process characterization and drug product fill liaison. - Authoring, reviewing and approving CMC documentation supporting IND submission and ensure regulatory compliance through deviation investigation, CAPA, risk management and patent application review. - mAb, bi/multispecific-Ab, Fc-fusion, Enzyme, Biosimilars, and ADC.
- DSPD team and laboratory setup, startup of DSPD operations. - Team management to deliver multiple projects on time and within budget. - Design, development, process optimization, pilot scale, scale-up, and technology transfer of downstream processes for cGMP manufacturing. - CMC project management - planning, budgeting - Managing outsourced CDMO manufacturing and CRO projects. - mAb, bi/multispecific-Ab, Fc-fusion, Enzyme, Biosimilars. - Customer interaction, liaison with BD and PMO in the proposal generation and cost estimation of projects.
- Design, development and technology transfer of ATMP downstream processes for GMP manufacturing. - Extracellular Vesicles, mRNA, Adeno Asociated Virus and Lentivirus - Team management to deliver multiple projects on time and within budget. - Liaison with sales and PMO in the proposal generation and cost estimation of projects.
- Platform owner and responsible for development of non-mAb DSP and DSP PD automation processes. - Design and development of biologics downstream processes for GMP manufacturing. - CMC project management - budgeting, coordination - Managing outsourced CDMO and CRO projects - Team management to deliver multiple projects on time and within budget. - Liaison with sales and PMO in the proposal generation and cost estimation of projects.
- Leading DSP CMC activities on biologics and providing assistance to PM and sales on timelines, delivery and cost estimation of projects. - Process characterization and automation of DSP process development activities.
- Contract Research in Early Phase Drug Discovery. - Characterization of protein-ligand interactions and therapeutic protein candidates. - Design of recombinant protein expression and purification strategies for drug discovery. - Research on protein dynamics role in kinetics and thermodynamins of protein-ligand binding.
- Early phase drug discovery. - Research on druggability of disordered and flexible proteins. - Production and characterization of recombinant proteins for drug discovery. - Design of recombinant protein constructs for structural, biophysical, and biochemical studies. - Biochemical and biophysical characterization of protein-protein and protein-ligand interaction by NMR/SPR/ITC. Fragment screening by NMR, hit identification and validation.
- Biophysical and biochemical characterization of large protein assemblies by NMR. - Design and optimization of recombinant expression and purification of isotopically labeled proteins.