Basel, Basel, Switzerland
Lead and Manage lab scientists (up to 4 direct reports) Functional lead, responsible for the design, execution and delivery of pharmaceutical development studies for liquid parenteral drug products of large molecule biologics. • Agree with customer on study design and draft the contract • Evaluate cost and resources • Coordinate the team for execution and delivery of the laboratory work and data processing (reviewing lab work plan, supporting data interpretation, troubleshoot). • Write and deliver final reports Innovation: Review and be involved in the design of workpackage and new proposal (robustness, early stage screening). DoE support using JMP (for data interpretation and workpackage design)
Managing up to 2 direct reports (deputy team lead) Celonic’s PTM in customer project representing all analytics (MD and QC) • Set-up strategy for analytical programs during program lifecycle (from proposal generation, kick-off, process development, manufacturing and transfer of processes) • Initiation of analytical method evaluation, development and validation. • Propose the design of stability study (ICH) and draft CQA and QTPP in communication with the customer to establish development goals and analytical strategy for development and GMP runs. • Draft comparability studies and specification justifications • Maintain the up to date knowledge on molecule to propose analytical workflow within the global QbD/CMC strategy. • Review IND • Lead technical discussion in presence of SME and support method troubleshooting Maintain communication with Project manager regarding resources, costs and timelines and act as part time PM when necessary. Supporting Celonic’s Sales, CLD, USP and DSP departments to offer and apply appropriate analytical strategy (what analytics, when) during product/process development. Presentation (Power point) of analytical data and interpretation support (internally and with clients) Reviewing USP/DSP/MD reports (e.g methods evaluation, validation reports). Reviewing of formulation proposals from external suppliers to advise clients with the best strategy. Data interpretation. Intermediate DoE/statistical support using JMP within global QbD/CMC strategy (data trending, DoE design for formulation, stability and method development, correlation).
Management/Design and Development of a platform for analytical characterisation strategy/cascade (selection of appropriate fit for stage analytical methods to support RD from concept assessment (large number of candidates) to lead candidate selection and to support developability workflow). Analytical methods covered: stability (particles characterisation, fragmentation, charge variants, unfolding, monomer loss) process recovery (ELISA/titer methods), Affinity (Binding Assays). Design and development of an early-stage formulation platform supported by DoE: Identification of best formulation for storage and handling per molecule family followed by supporting candidate selection and design based on short term stress study and stability study (adapted from the ICH guidance) with appropriate read out (particles/aggregation, fragmentation, precipitation, charge variants, unfolding, binding) and identification of key factors using JMP. Identification and development of administration vehicle/formulation for in vivo studies (based on syringe recovery). Member of the global formulation team (GFT), including centre of excellence for excipient: creation of an early stage pre formulation platform supported by DoE within a global characterisation strategy in line with CMC and late stage formulation, (early formulation buffer for storage and in vivo administration, CQA identification; transfer of methods; transfer of molecule knowledge). Transfer of molecule and formulation knowledge package to early-CMC and formulation departments. Adapt, Innovate and report strategy proposal to senior group leaders (research Project Managers, CMC manager, Formulation manager, R&D VP) upon project requirement and challenges over four sites (France, England, Wales, USA) Scouting, Budget Request and implementation of technology covering cells assay, biophysics characterisation, target expression, quantitation, data management) with budget request report writing (CDA, MTA)
Analytical method development and early-stage validation (based on ICH guidance) including: binding assay (BLI, SPR, ITC), titer assay (BLI, ELISA, JESS), purity assays (cIEF, CE-SDS) and fluorescence assays for hydrophobicity and stability. DoE screening for method development and stability data processing Screening of molecules for binding and titer (during process development at RD level, and for syringe recovery to support in vivo studies). Screening of molecules for their stability using SLS, DLS and nano DSF. Transfer of methods and knowledge package on methods/molecules including operator training to the early CMC-team. Supervising up to 3 interns (training/supervision) and Stakeholders meeting/report
Management and coordination of up to 10 projects in parallel for 8 pharma partners Protein Construct rational design Large scale membrane protein mammalian expression and purification (with optimization) Membrane protein biophysical (stability, aggregation using nanoDSF and DLS/SLS) and Structural (Crystallography, cryo-EM) characterization (contribution to PDB: 6DQ5, 6Y5V, 7AIN, 7AIO, 7AIP, 7AIQ, 7AIR, 7NGB) Functional characterisation (based on ligand binding using SPR and thermostability) Development/optimisation of strategies and processes to provide deliverables to 8 pharma partners with monthly and quarterly reports with pharma partners timelines (10 projects in parallel). Supervision of research associates and PhD/master students