Sr. Director External Manufacturing

Sr. Director External Manufacturing

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary:

Reporting to the VP, Global Manufacturing & Supply Chain, the Sr. Director External Manufacturing will provide strategic, technical, and operational leadership for all aspects of outsourced manufacturing across drug substance, drug product and packaging/labeling for late-stage development and commercial programs. This role is responsible for end-to-end oversight of CDMO partnerships to ensure reliable, compliant, and cost-effective supply of small molecule APIs and oral solid dose (OSD) products.

Job Responsibilities:

• Attract and retain a high-caliber, collaborative and experienced team of manufacturing professionals to establish and oversee Structure Tx's CDMO network.
• Define and execute the external manufacturing strategy to support late-stage development, PPQ, commercialization, and lifecycle management.
• Provide end-to-end oversight of CDMOs across drug substance and drug product manufacturing.
• Establish scalable operating models, governance structures, and performance management systems for external partners.
• Ensure alignment of manufacturing strategy with supply chain, quality, and regulatory objectives.

• Lead identification, evaluation, and selection of CDMOs for API and drug product manufacturing.
• Establish and maintain strong executive-level relationships with CDMO partners.
• Lead business review meetings and governance forums to monitor performance and drive accountability.
• Define, implement, and monitor KPIs to ensure CDMO performance meets quality, delivery, and cost expectations.
• Drive continuous improvement initiatives across the external network.

• Oversee technology transfer of processes from development to manufacturing sites.
• Ensure successful execution of process validation (PPQ) and continuous process verification (CPV) activities
• Collaborate with Commercial, Supply Chain, Quality and Regulatory Affairs colleagues to define and execute successful commercial product launch plans.

• Oversee ongoing production activities at CDMOs for drug substance, drug product, and packaging & labeling operations.
• Collaborate with Supply Chain to support production planning, demand forecasting, and order management.
• Ensure alignment of production schedules with supply plans and inventory strategies.
• Monitor manufacturing campaigns to ensure adherence to timelines, yield targets, and cost expectations.

• Provide technical leadership across unit operations including API synthesis, spray-dried dispersions, tableting, and bottling/packaging.
• Ensure successful investigation and resolution of manufacturing deviations, non-conformances, and product complaints.
• Drive rapid and effective technical troubleshooting to maintain uninterrupted supply.
• Use proven continuous improvement methods to understand problems at the root level and implement the necessary long-term fixes to ensure reliable and high-quality product supply.

• Ensure all external manufacturing activities comply with global GMP and regulatory requirements.
• Partner closely with Quality to support batch release, investigations, validation, continued process verification (CPV).
• Partner with Quality to…