Director, Analytical Development (Small Molecule)

Structure Therapeutics•South San Francisco, CA

15h

About The Position

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 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.

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.