Sr. Director External Manufacturing

Structure Therapeutics•South San Francisco, CA

21h•Remote

About The Position

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.

Requirements

S. in Chemistry, Chemical Engineering, or related discipline required; advanced degree (M.S., Ph.D. or MBA) preferred.
15+ years of experience in pharmaceutical manufacturing, including significant experience managing external manufacturing and global CDMOs.
Deep expertise in small molecule manufacturing and oral solid dose (OSD) products.
Strong understanding of unit operations from API synthesis through drug product manufacturing and packaging & labeling.
Demonstrated experience supporting late-stage development, PPQ, and commercial product launches.
Proven track record of CDMO selection, management, and performance optimization.
Strong knowledge of GMP regulations, validation, CPV, and quality systems.
Experience working with global manufacturing networks and international CDMOs across multiple time zones.
Strong technical troubleshooting and problem-solving skills in manufacturing environments.
Experience with supply chain integration, production planning, and capacity management.
Excellent leadership, communication, and cross-functional collaboration skills.
Ability to operate effectively in a fast-paced, matrixed, and virtual organization.
Strategic thinker with strong execution and decision-making capabilities.
Proven ability to build high-performing teams and operate in matrix environments.
Strategic thinker with strong execution capabilities.
Excellent communication and cross-functional influence.

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 ensure effective deviation management, root cause analysis, and CAPA implementation.
Support regulatory inspections and ensure inspection readiness across CDMOs.
Coordinate shipping, logistics, and material flow between global manufacturing sites.
Ensure seamless integration between drug substance, drug product, and packaging operations.
Lead long-range manufacturing network capacity planning to ensure alignment with commercial demand forecasts.
Identify and mitigate supply risks through proactive risk management, including dual sourcing, capacity buffering, and scenario planning.
Provide input into budgeting, forecasting, and cost management of external manufacturing.
Partner effectively with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, Clinical Operations and Commercial teams to ensure uninterrupted supply of late phase clinical and commercial supplies.
Serve as a key member of the Manufacturing & Supply Chain and Technical Operations teams.
Support regulatory filings and lifecycle management activities.
Play leading role in commercial launch planning and execution and serve as the central point person for planning, coordination and communication with CDMO partners and internal stakeholders during new product launch.