Executive Director, Analytical Development (Small Molecule)

Structure Therapeutics•South San Francisco, CA

15h•$260,000 - $332,000

About The Position

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 SVP Tech Ops, The Executive Director, Analytical Development (Small Molecule) will provide strategic, scientific, and organizational leadership for analytical development and quality control activities supporting late-stage development, PPQ, commercialization, and global regulatory filings. This executive will oversee method development, qualification, validation, specification strategy, stability programs, and analytical control systems across drug substance and drug product.

Requirements

Ph.D. (preferred) or M.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline.
15+ years of industry experience in small-molecule analytical development.
Leadership of Late stage programs through commercial launch, including PPQ and QC strategy.
Significant NDA/MAA/regulatory authorship and defense experience.
Expertise in ICH guidelines, method validation, and impurity control.
Leadership of analytical teams and oversight of external labs.
Strong understanding of GMP QC operations and data integrity.
Experience in high-growth biotech or virtual manufacturing environments.
Global commercial supply leadership experience.
Proven ability to build high-performing teams and operate in matrix environments.
Strategic thinker with strong execution capabilities.
Excellent communication and cross-functional influence.
Strong decision-making, prioritization, and risk‑management skills.
Commitment to quality, scientific rigor, and operational excellence.

Responsibilities

Strategic Leadership & Vision Set the long-term strategy for analytical development and QC to support late stage, PPQ, launch, and lifecycle management.
Define analytical control strategies aligned with QbD principles, risk assessments, and regulatory requirements.
Lead analytical readiness for commercialization, including validation packages, method transfers, and stability programs.
Develop team capabilities, infrastructure, and talent to support a growing portfolio.
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 Provide oversight of QC release testing, stability testing, and GMP support activities.
Ensure compliance with global GMP expectations and data integrity.
Support OOS/OOT investigations, root-cause analysis, and CAPA programs.
Ensure QC readiness for PPQ and commercial operations.
Regulatory Strategy & Submissions Lead analytical content for NDA, MAA, and global submissions.
Represent the company in regulatory agency meetings.
Guide global specifications and analytical protocols per ICH and regional requirements.
Cross-Functional Influence & CMC Leadership Partner with Drug Substance, Drug Product, Quality, Supply Chain, and Regulatory CMC teams.
Serve on CMC leadership committees and provide oversight of analytical deliverables.
Contribute to PPQ campaigns, tech transfers, and commercial readiness.
External Partnerships (CDMOs, CROs, Testing Labs) Oversee analytical work at CDMOs/CROs, including method development, transfer, and validation.
Manage performance and technical governance of external labs.
Lead technical due diligence for partners or acquisitions.