♦ Responsible for a CMC team of up to 6 members, covering all activities related to technical CMC and regulatory CMC♦ Oversight of the CMC department’s resource management (budget, human skills), coordination of the project management of the various CMC projects, as well as training and appraisal of the team members♦ Defining the CMC/RA strategy (regional, global) upon consultation with other departments ♦ Authoring, review and the timely preparation and submission of regulatory CMC documents (IMPD, QOS and CTD Module 3 of IND and NDA, MAA) ♦ Preparation and participation in CMC-focused interactions with NCAs (SA, EoP2, Pre-IND meetings, responses to queries)♦ Long-standing expertise in (1) selecting and qualifying/ co-auditing CMOs, CDMOs, CS providers and testing laboratories, (2) closely collaborating with the CDMOs on the manufacture of DS and DP (esp. sterile solutions and powders)♦ Compilation of production plans and budgets for drug manufacture and supply♦ Planning and alignment with CDMOs on technical batches, process development, GMP batches, scale up, and process validation (PPQ) of DS and DP♦ Review and approval of MBRs and PBRs for all manufacturing activities, and of plans and reports for analytical testing and stability studies♦ Defining stability studies (long-term, accelerated, photostability, in-use stability) and extractables-and-leachables studies. Conducting trend analysis of stability data (DS and DP) and assigning shelf-life to DP♦ CMC-lead for two pivotal, global PhIII and several PhI-PhII studies♦ Regulatory Intelligence: Keeping the team up-to-date on new and changing regulations and guidelines ♦ Support of QA by (1) developing SOPs related to CMC, supply chain and GMP/GDP suppliers, (2) organizing and participating in CDMO audits♦ Provision of CMC expertise during due diligence (DD) and partnering activities♦ Close cooperation with Clinical Operations (ClinOps), the DMPK/ ADME-Tox and formulation teams

☛ For details see latest CMC position

☛ For details see latest CMC position

♦ Drafting, reviewing, and negotiating contracts, in particular MTAs, CDAs, Supply Agreements, Manufacturing Contracts and Quality Agreements ♦ Training in Contract Law at the University of St. Gallen/ Switzerland♦ Implementation and maintenance of Polyphor’s contract database (CRM WinCard and SharePoint)♦ Co-invention and conceptualizing of the MacroFinder patents

♦ Promoting the Small Molecules Business Units (SMBU) products and services, i.e., screening libraries, custom synthesis, and lead optimization services♦ Key account management

♦ Heading and couching the route scouting and lead optimization group ♦ Resource management (budget and human skills) of the group♦ Oversight of > 30 custom synthesis/ lead optimization projects per year♦ Optimization of synthetic procedures for use in the parallel synthesis group

♦ Lead optimization from hit to candidate for inflammatory diseases, esp. asthma and COPD♦ Suggestion of new structures/ compounds for enhancement of the screening library♦ Process Chemistry: Process optimization and up-scale to 1kg batches