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 Principal Scientist/or Associate Director of Analytical Development will be responsible for Structure Therapeutics’ small molecule CMC projects in terms of the development of analytical methodology and characterization of drug substances and drug products. This individual will support all analytical 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. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.

Essential Duties and responsibilities

• Identify analytical science capabilities and tools to characterize and support the manufacturing process development and QC testing for new drug candidates
• Responsible for developing and implementing analytical strategies for development stage projects to achieve optimal results.
• Apply scientifically-driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for development compounds; raw materials, intermediates, drug substances (DS) and drug product (DP).
• Manage CRO/CDMO for analytical activities for DS and DP: method development, characterization testing, and review of raw data packages.
• Prepare and review relevant DS and DPs, protocols SOPs, and reports to support laboratory GMP functions in compliance with FDA/regulatory guidance.
• Check analytical data generated by the group. Ensures quality, accuracy and compliance status of the data generated.
• Provide technical input in investigations such as OOS, OOT and anomalous results during research or DOE experiments.
• Contribute to specifications for key raw materials, regulatory starting materials, IPC, intermediates, drug substances and drug products.
• Author, review, and delivers technical documents for regulatory submissions.
• Support IND/IMPD/NDA regulatory submissions by developing suitable specifications, ensuring that scientifically sound analytical methods are applied, ensuring that analytical information is shared within the project team. Define and implement plans of action to respond to deficiencies. Responsible for the analytical documentation necessary for filing.
• Manage different analytical activities and ensure that, for the assigned projects, all the necessary analytical tasks for development, registration, filings and responses to deficiencies and other testing are correctly identified and executed within the project time-lines. Ensure that results, potential issues or delays are communicated in a timely manner to the project team and management. Participate in definition of project strategies and timelines. Monitor and drive changes to the current systems, processes, procedures and work toward refining and improving them.
• Work effecitively with other line functions including QA, RA, QC, DS and DP
• Ensure that CROs and CDMOs maintains compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and NMPA regulations.
• Oversee daily activities for analytical development activities at CROs and CDMOs including method development, method validation, method transfer
  
  

QUALIFICATIONS

• Ph. D or M.S’s degree in chemistry, related field or equivalent.
• 10+ years of relevant working experience in analytical development in biotech/pharma industry. Being skilled in the application of cGLP/cGMP is required.
• Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical or pharmaceutical science.
• Detail-oriented. 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 modern analytical chemistry techniques. Outstanding problem-solving abilities.
• Demonstrated knowledge of analytical development, validation, analytical instrumentation, chemistry along with the ability to troubleshoot analytical methods.
• Basic knowledge of organic/inorganic chemistry is required.
• Project management skills are required.
• Demonstrate a proven track record in working with and managing CROs and CDMOs for protocol design and study execution
• 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.
• Language required: English and Chinese