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Karsten Marx is listed as Head CMC at Spexis AG, based in Basel, Switzerland. AeroLeads shows a matched LinkedIn profile for Karsten Marx.
Karsten Marx previously worked as Head CMC at Polyphor Ltd and CMC/RA & Supply Chain Manager at Polyphor Ltd. Karsten Marx holds Postdoc, Iridium Catalyzed Assymetric Synthesis, Ligand Design from Kyoto University.
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Email format at Spexis AG
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Spexis AG
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About Karsten Marx
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
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8 roles · 26 years
Karsten Marx work experience
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Head Cmc
Current♦ 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
2022 - Present
~4 yrs 6 mos
Head Cmc
Polyphor Ltd
☛ For details see latest CMC position
2019 - 2021
~2 yrs
Cmc/Ra & Supply Chain Manager
Polyphor Ltd
☛ For details see latest CMC position
2014 - 2019
~5 yrs
Ip & Contract Management
Polyphor Ltd
♦ 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
2009 - 2014
~5 yrs
Head Business Development Smbu
♦ Promoting the Small Molecules Business Units (SMBU) products and services, i.e., screening libraries, custom synthesis, and lead optimization services♦ Key account management
2006 - 2009
~3 yrs
Head Of R&D Smbu
♦ 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
2004 - 2006
~2 yrs
Medicinal Chemist
♦ 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
2001 - 2004
~3 yrs
3 education records
Karsten Marx education
Postdoc, Iridium Catalyzed Assymetric Synthesis, Ligand Design
D.Sc., Organic Chemistry: Heterocyclic Chemistry, Pericyclic Reactions, Qm Calculations
Pericyclic Reactions, Nitrones, Pm3 Calculations
FAQ
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What company does Karsten Marx work for?
Karsten Marx works for Spexis AG.
What is Karsten Marx's role at Spexis AG?
Karsten Marx is listed as Head CMC at Spexis AG.
Where is Karsten Marx based?
Karsten Marx is based in Basel, Switzerland while working with Spexis AG.
What companies has Karsten Marx worked for?
Karsten Marx has worked for Spexis Ag, Polyphor Ltd, and Bayer Yakuhin (Japanese Branch Of Bayer Healthcare).
How can I contact Karsten Marx?
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What schools did Karsten Marx attend?
Karsten Marx holds Postdoc, Iridium Catalyzed Assymetric Synthesis, Ligand Design from Kyoto University.
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