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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 Executive Director of Active Pharmaceutical Ingredient (API) will be responsible for small molecule
API Development for Structure Therapeutics’ CMC projects including design of alternative syntheses,
development of reproducible, robust manufacturing processes under cGMP. This individual will support
all drug substance 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

• 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;
• Understands the strategy of API process development for early and late stages of projects
• Interacts efficiently and effectively with other line functions including Medchem, tox and clinical
  operation to deliver projects in time with high quality.
• Clearly understands the developmental issues of projects and develops strategies to resolve
  them;
• Directs internal and 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 time
• Manages all aspects of compliance issues (cGMP requirements and EHS regulations).
• Clearly communicates project progress and needs, and interfaces with analytical, engineering,
  technical services, process research groups to function as one team.
• Mentors process chemists at CROs and CDMOs on variety of subjects including process
  development, scale up, regulations and pilot plant/kilo lab equipment if needed.
• Monitor the progress of projects and provides technical solutions to CRO and CDMO chemists to solve issues occurring during process development.
• 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.
• Ensure that CROs and CDMOs maintains compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and NMPA regulations.
• Oversee daily activities for drug substance development at CROs and CDMOs.
• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance (For all Supervising Managers)

• Other duties as assigned

Core Competencies, Knowledge and Skill Requirements

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Communication & Interpersonal Skills

• Language required: English and Chinese
• Excellent verbal and written communication skills

• Ability to effectively collaborate in a dynamic environment

QUALIFICATIONS

• Ph. D. degree in Organic chemistry, preferred in Organic Synthesis
• 15+ years of working experience in API development in biotech/pharma industry or CROs. 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.