Source Job

• Lead analytical strategies for commercial products, ensuring compliant and robust methods and specifications.
• Manage method transfers, validations, and lifecycle activities while collaborating with CDMOs and cross-functional teams.
• Contribute analytical expertise to regulatory submissions and support health authority inspections.

The company is a science-driven biopharmaceutical organization focused on developing and commercializing small-molecule drugs. They foster a collaborative culture with engaged colleagues and emphasize scientific excellence.

• Lead drug product CMC strategy for small molecule programs from early to late stage.
• Oversee formulation, process development, scale-up, technology transfer, and validation.
• Manage CDMOs and external partners to ensure quality, timelines, and supply continuity.

Our partner is a biotechnology company focused on advancing small molecule drug product development. They operate in a fast-moving, highly outsourced environment with a collaborative, patient-focused culture.