Director, Analytical Development (Small Molecule)

About Us:

Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys 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 clinicalstage 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 Executive Director Analytical Development the Director of Analytical Development will be responsible for analytical development activities supporting late-stage development Phase 3 programs PPQ commercialization and global regulatory filings. These activities will include external oversight of method development qualification validation specification strategy stability programs and analytical control systems across drug substance and drug product.

This role requires deep expertise in small-molecule analytical sciences regulatory expectations for global regulatory submissions experience supporting commercial readiness ICH-compliant QC operations and cross-functional CMC strategy. The successful candidate will support late stage clinical starts marketing application submissions regulatory authority inspections and product launch.

Job Responsibilities:

Analytical Development & Method Lifecycle Management

• Oversee development optimization qualification and validation of analytical methods for DS and DP.
• Ensure methods align with ICH Q2(R2) Q6A Q8 and related guidelines.
• Lead impurity control strategy development and regulatory justification.
• Implement method lifecycle processes and continuous improvement.

Quality Control & GMP Support

• Partner with QC and QA to provide oversight of release testing stability testing and GMP support activities.
• Support OOS/OOT investigations root-cause analysis and CAPA programs.
• Ensure readiness for PPQ and commercial operations.

Regulatory Strategy & Submissions

• Author analytical content for IND NDA MAA and global submissions.
• Perform content review of dossier sections including source document tracking and data verification.
• Author review and approve analytical development reports to support marketing applications.
• Review and approve global specifications and analytical protocols per ICH and regional requirements.

Cross-Functional CMC Development

• Partner with Drug Substance Drug Product Quality Supply Chain and Regulatory CMC teams.
• Contribute to PPQ campaigns tech transfers and commercial readiness.
• Partner with early-stage project teams to ensure smooth transfer of projects to late-stage development.

External Partnerships (CDMOs CROs Testing Labs)

• Oversee analytical work at CDMOs/CROs including:
  • Establishment and periodic revision of specifications.
  • Method development transfer and validation.
  • Identification and development of control strategies for impurities.
  • Stability protocols stability reports and retest / shelf-life extensions.
  • Establishment and maintenance of reference standards.
• Participate in technical due diligence for partners or acquisitions.

Qualifications:

• B.S. in Analytical Chemistry Pharmaceutical Sciences Chemistry or related discipline (M.S. or Ph.D. also considered).
• 10 years of relevant industry experience or less experience with an advanced degree.
• Deep expertise in analytical development for small molecule API and oral solid dose (OSD) products.
• Significant regulatory dossier authorship and defense experience.
• Expertise in ICH guidelines method validation and impurity control.
• Strong understanding of GMP QC operations and data integrity.
• Ability to operate effectively in a fast-paced matrixed and virtual organization.
• Strategic thinker with strong execution and decision-making capabilities.
  
• Excellent communication and cross-functional influence.

Travel Required: up to 15% globally

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. For this role the anticipated base pay range is $205K-$258K. The exact base pay offered for this role will depend on various factors including but not limited to the candidates 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 and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings including but not limited to medical dental and vision insurance 401k match unlimited PTO and a number of paid holidays including winter shutdown.

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Required Experience:

Director