Associate Director to Director of Drug Substance

About Us:

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.

Position Summary:

Reporting to the Tech Ops Head of Drug Substance, this position will be responsible for Structure Therapeutics’ small molecule Technical Operations projects in terms of the development of drug substances. This individual will support late-stage drug substance activities in contract development and manufacturing organizations (CDMOs). This role will focus on late stage and commercialization readiness. 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. This role develops robust and scalable synthetic routes suitable for commercialization.

Job Responsibilities:

• Experience in GMP small-molecule drug substance manufacturing, including multi-step chemical synthesis.
• Deep understanding of organic chemistry, reaction mechanisms, impurity formation, crystallization, and isolation techniques.
• Strong experience with process scale-up, kilo lab → pilot → commercial scale, including equipment selection and process safety considerations.
• Expertise in technology transfer of chemical processes between development and manufacturing (internal or CDMO).
• Familiarity with process safety assessments (HAZOP, risk assessment, thermal stability studies) and handling hazardous reagents/solvents.
• Proven experience supporting process validation (PPQ) and continued process verification for API manufacturing.
• Knowledge of ICH Q7, Q11, and regulatory expectations for small-molecule drug substance.
• Directs CRO teams to perform experiments to define process parameters intended to develop suitable processes for chemical manufacturing and commercialization. Must apply organic chemistry, chemical engineering, safety and green chemistry principles to design concise synthesis and experiments, optimize reactions, streamline workup procedures, and reduce cost and cycle times.
• Manages all aspects of compliance issues (cGMP requirements and EHS regulations).
• Monitor the progress of projects and provides technical solutions to CRO and CDMO chemists to solve issues occurring during process development.

• Author, review, and deliver technical documents for regulatory submissions.
• Ensure that CROs and CDMOs maintain compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and NMPA regulations.
• Oversee daily activities for drug substance development at CROs and CDMOs.
  
  

Qualifications:

• Ph. D or M.S’s degree in Organic chemistry, preferred in Organic Synthesis
• 10+ years of working experience in API development in biotech/pharma industry. Being skilled in the application of GLP/cGMP is required.
• Extensive drug substance process development background and hands on experiences with working knowledge of cGMP manufacturing.
• 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 organic chemistry techniques. Outstanding problem-solving abilities.
• Demonstrate knowledge of drug substance 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 for new synthesis design and execution in the lab and manufacturing.
• 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.
• Excellent team player.
• Language required: English and Chinese

Travel Required: No

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, ongoing performance-based equity and various benefits offerings.

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