VP, Drug Product Technical Operations

Company: Structure Therapeutics

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 VP of Drug Product Technical Operations will be responsible for CMC strategies for 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 DP under cGMP. The candidate will be an expert in formulation technologies including parenteral, oral and device methodologies. The candidate should also possess a deep understanding of technologies for delivering poorly soluble compounds such as ASDs. The VP of Drug Product Technical Operations will be responsible for the transition of early-stage assets to Phase 3 and to design processes that are amenable to commercialization. This individual will support late phase projects for all 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 on 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. Excellent communication skills are a must for this multidisciplinary and global effort.

Key Responsibilities

• Develops a robust scalable DP process for Structure's lead asset Aleniglipron
• Facilitates the transfer of DP early-stage programs to Phase 3 and commercialization
• 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.
• Communicate effectively with other line functions externally and internally including Clinical Operations, QA, QC, Supply Chain and CDMOs to align the development strategies.
• Clearly understands the developmental issues of late phase projects and develops strategies to resolve them.
• Coordinates drug product manufacturing, process development, scale-up, and clinical manufacturing.
• Master in QbD and development requirements for 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 at different locations across globe and select appropriate CROs and CDMOs for StructureTx projects to deliver projects in time with high quality.
• Helps develop a global supply strategy including multiple manufacturing sites.
• 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.

Qualifications

• Ph. D. degree in Organic chemistry or pharmaceutical Science.
• 20+ years of working experience in DP development in biotech/pharma industry.
• Detailed oriented and well-versed in working in a regulated environment.
• Proven leader in DP process technologies.
• Experience in late-stage development and launching a product.
• Experience in tech transfer, scale-up, process validation, and regulatory document preparation.
• Detail-oriented. Familiar with manufacturing facilities and sourcing strategy for DP. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Outstanding problem-solving abilities.
• Knowledge of modern delivery systems including ASDs, liposomes, LAIs, FDCs.
• Excellent 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.

The target salary range for this full-time role is $305,000 - $370,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.