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 has completed an initial public offering (IPO) in February of 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

The ED/VP CMC Head of Late Development will be responsible for CMC strategies of small molecule API and DP Development for Structure Therapeutics’ projects including development of late phase projects and outsourcing strategies for CMC activities both in and outside the US, especially for manufacturing of DS and DP under cGMP. This individual will support late phase projects for all drug substance and drug product activities in contract development and manufacturing organizations (CDMOs). All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. In addition, this individual will ensure robust and healthy communication with internal CMC and clinical teams including QA, QC, Regulatory Affairs, Supply Chain, clinical operations to fulfill Structure Therapeutics’ commitment to patients and regulatory filings.

Key Responsibilities

• Leads and manages multiple projects simultaneously, allocates resources and coordinates project activities to facilitate the achievements of major milestones of projects to ensure required deliveries on time.
• Interacts effectively with other line functions externally and internally including clinical operations, QA, QC, Resupply Chain and CDMOs to align the development strategies.
• Clearly understands the developmental issues of late phase projects and develops strategies to resolve them.
• Coordinate drug substance and product manufacturing, process development, scale-up, and clinical manufacturing.
• Ensure analytical lifecycle requirements are met at CDMOs in partnership.
• Master in QbD and development requirements for DS and DP in late phase projects.
• Manages all aspects of compliance issues for cGMP requirements and EHS regulations.
• Clearly communicates project progress and needs, and interfaces with clinical operation, analytical, engineering, technical services, process research groups to function as one team.
• Develop strategies of manufacturing for DP and DS at different locations across globe and select appropriate CROs and CDMOs for StructureTx projects to deliver projects in time with high quality.
• Proactively participates in team activities as an excellent team player, contributes to project deliverables.
• Author, review, and delivers technical documents for regulatory submissions and publications.
• Ensures that CROs and CDMOs maintains compliance with cGMP, GCP, FDA, ICH guidelines, SOPs, and NMPA regulations.
• Oversee strategy implementation for drug substance and drug product manufacturing at CROs and CDMOs.
• Language required: English (plus with Chinese)

QUALIFICATIONS:

• Ph. D. degree in Organic chemistry or pharmaceutical Science
• 15 years of working experience in DS and DP development in biotech/pharma industry.
• Deep knowledge and experience in cGMP, GCP, ICH and requirements form different regulatory agencies.
• Experience in tech transfer, scale-up, process validation, and regulatory document preparation.
• Detail-oriented. Familiar with manufacturing facilities and sourcing strategy for DS and DP. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Have both broad and in-depth knowledge as well as hands-on experience in CMC late phase development. Outstanding problem-solving abilities.
• Demonstrate knowledge of drug substance and drug product development, the ability to troubleshoot process development issues.
• Project management skills are required.
• Demonstrate a proven track record in working with and managing CROs and CDMOs.
• Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
• Strong interpersonal skills, seasoned ability to influence, responsiveness, a high level of attention to detail and excellent team player.
• Collaborative approach with excellent relationship building and influencing abilities.