(associate director) senior scientist – manufacturing, global ms&t

(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