Berlin Metropolitan Area
As a Chemistry, Manufacturing and Controls (CMC) Expert and detail-oriented person, I am passionate about the CMC interface between precise analytical/ scientific data (technical CMC) and laws/ regulations (regulatory CMC, Regulatory Affairs RA). One of my main responsibilities is the timely delivery of high-quality documents/ files (1) for submission to NCAs (QOS, IMPD, IND, CTD, NDA), (2) in preparation of meetings with CAs (SA, EoP2) and (3) in response to their queries. As the clock of regulatory authorities is always, my hands-on attitude is important as is keeping a clear overview under time pressure. Within the organization, I foster and enjoy close interactions (1) with ClinOps for the correct planning and timely delivery of clinical supply (CS, CTS), (2) with ADME/Tox for new qualification limits of impurities, definition of PDEs, (3) with Chemistry for lead optimization and formulation development, and (4) with QA for handling CMC-related aspects of the QMS. For external contacts like coordinating with CROs and selecting, qualifying, and managing CMOs, CDMOs and CS providers, my additional experience in BD, contract law and management, medicinal chemistry and process chemistry are additional assets
♦ Oversight, management and support of the CMC project leads responsible for late-stage programs (PhII and beyond) ♦ CMC lead for a global PhIII study ♦ Defining late-stage CMC strategies for rapid, cost-effective, and high-quality programs ♦ Partnering with the early-stage CMC development team to ensure a smooth hand-over of programs ♦ Identification and mitigation of business and quality risks ♦ Responsible for siRNA DS and DP manufacturing, scale-up, process and analytical development and validation ♦ Close cooperation and coordination with the non-clinical and clinical and clinical supply groups ♦ Oversight and support of for the forecast and manufacture of proprietary starting materials ♦ Review and support for the timely submission of regulatory CMC documents (IND, IMPD, QOS)
♦ 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
♦ 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