<p><strong>(Associate Director) Senior Scientist – Manufacturing, Global MS&T (Linker-Payload/Small Molecules)</strong></p><p><br></p><p>Location: Frankfurt/Munich/Berlin</p><p><br></p><p><strong>About the Role</strong></p><p>A globally active biopharmaceutical organisation is seeking an experienced Senior Scientist / Associate Director to join its Manufacturing Science & Technology (MS&T) team, supporting complex small molecule and conjugated product manufacturing.</p><p><br></p><p>This position focuses on linker-payloads, APIs, and highly potent small molecules, playing a key role in ensuring robust, scalable, and compliant manufacturing across an international network of external partners.</p><p><br></p><p>You will act as a technical expert and key interface between internal development teams and external manufacturers, supporting late-stage clinical and commercial programs through process understanding, optimization, and lifecycle management.</p><p><br></p><p><strong>Key Responsibilities</strong></p><ul><li>Provide scientific and technical leadership for the manufacture, transfer, and lifecycle management of small molecule and linker-payload processes</li><li>Serve as a process subject matter expert, supporting process performance, technical troubleshooting, and continuous improvement initiatives</li><li>Lead and support technology transfer, scale-up, and process validation readiness across external manufacturing sites</li><li>Drive investigations and quality activities, including deviations, root cause analysis, CAPAs, change controls, and risk assessments</li><li>Author, review, and approve technical documentation, including manufacturing instructions, validation/qualification documents, and process transfer packages</li><li>Collaborate closely with internal CMC/technical development teams and external CDMOs/CMOs to ensure alignment and execution</li><li>Monitor process performance using KPIs and risk-based approaches, supporting harmonisation and optimisation across sites</li><li>Contribute to regulatory submissions and responses, ensuring manufacturing processes meet global compliance requirements</li></ul><p><br></p><p><strong>Candidate Profile</strong></p><ul><li>MSc or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or Pharmaceutical Sciences</li><li>Strong industry experience within GMP-regulated pharmaceutical or biotech environments</li><li>Proven expertise in small molecule/API manufacturing or chemical process development</li><li>Experience with linker-payloads, highly potent compounds, or ADC-related materials is advantageous</li><li>Solid understanding of process scale-up, technology transfer, lifecycle management, and troubleshooting in GMP settings</li><li>Hands-on experience managing deviations, CAPAs, change controls, and validation/qualification documentation</li><li>Familiarity with global regulatory requirements (e.g. IND, IMPD, BLA, MAA submissions)</li><li>Strong communication and stakeholder management skills, with a structured and solution-oriented mindset</li><li>Fluent in English; Mandarin language skills are a plus</li></ul><p><br></p><p><strong>Why Join?</strong></p><ul><li>Opportunity to work on highly complex and innovative therapeutic modalities</li><li>Visible, cross-functional role within a global manufacturing network</li><li>Collaborative and science-driven culture focused on quality and continuous improvement</li><li>Clear opportunities for career progression and professional development</li><li>Flexible working environment designed to support performance and well-being</li></ul><p><br></p><p>If you would like to explore this opportunity in more detail, feel free to apply or get in touch for a confidential discussion</p><p></p>