structuretx
Sr. Director External Manufacturing
South San Francisco, California · Director
Sponsorship not specified$248k-$305kDetected 20 days ago
ForecastingBudgetingSupply ChainLogisticsHRPerformance ManagementGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingDemand PlanningRegulatory Affairs
About the role
- 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.
Responsibilities
- Define and execute the external manufacturing strategy to support late-stage development, PPQ, commercialization, and lifecycle management.
- Establish scalable operating models, governance structures, and performance management systems for external partners.
- 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.
Requirements
- 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.
- Experience with supply chain integration, production planning, and capacity management.
- Ability to operate effectively in a fast-paced, matrixed, and virtual organization.
- Travel Required: up to 30%, globally
- Strong technical troubleshooting and problem-solving skills in manufacturing environments.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Strategic thinker with strong execution and decision-making capabilities.
Nice to have
- S. in Chemistry, Chemical Engineering, or related discipline required
- advanced degree (M.S., Ph.D. or MBA) preferred.
Compensation
- For this role, the anticipated base pay range is $248K-$305K.
Benefits
- The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
- Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
Company info
- Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
- At Structure, base pay is only one part of your total compensation package.
Apply directly at structuretx →Create a free account for alerts like thisView structuretx immigration profile
This listing is sourced directly from structuretx's careers page and normalized into a canonical job model.