Downstream MSAT Lead - Drug Substance (w/m/d)

💼 Downstream MSAT Lead (m/f/d) - Drug Substance Projects

📍 Greater Munich Area

A dynamic biopharma organization in the Munich region is looking for a Senior Project Leader to take on the role of Downstream MSAT Lead, driving strategic and technical leadership in Drug Substance Manufacturing. This position is ideal for experienced project leaders who combine strong cross-functional coordination skills with deep expertise in Downstream Processing for biologics, including ADCs.

🔬 Your Mission



Lead cross-functional CMC project teams with a focus on downstream process strategy and execution

Oversee technology transfers, process validations, and site launches for clinical and commercial drug substances

Act as the technical authority for downstream purification, ensuring scalability, robustness, and compliance

Collaborate with CDMOs and internal stakeholders to align project timelines, deliverables, and quality standards

Contribute to regulatory documentation and inspections with downstream-related expertise



🧠 Your Profile



Advanced degree (Ph.D. or Master) in Biotechnology, Biochemistry, or Chemical Engineering

Proven track record in leading complex biopharma projects, ideally with a downstream focus

Strong understanding of GMP, CMC, and regulatory requirements

Excellent stakeholder management and communication skills across global teams



🌍 What You'll Gain



Strategic influence in shaping biomanufacturing operations

A collaborative environment with cutting-edge technologies

Career development opportunities in a science-driven, international setting



Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.