(Associate Director) Senior Scientist - Manufacturing, Global MS

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

Standort

Discover International, Frankfurt am Main