Structure Therapeutics · 1 day ago
Executive Director, Analytical Development (Small Molecule)
South San Francisco, CA
Full-time
Onsite
Director/Executive
$260K/yr - $332K/yr
15+ years expStructure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. 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, commercialization, and global regulatory filings.
BiotechnologyHealth CareMedicalPharmaceuticalProduct Research
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
Benefits
Medical, dental, and vision insurance
401k match
Unlimited PTO
Paid holidays including winter shutdown
Company
Structure Therapeutics
Structure Therapeutics specializes in the discovery and development of drugs against a type of targets called GPCR.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.77BKey Investors
Biotechnology Value FundQiming Venture Partners
2025-12-09Post Ipo Equity· $747.5M
2024-06-05Post Ipo Equity· $547.4M
2023-09-29Post Ipo Equity· $300M
Leadership Team
Raymond Stevens
Chief Executive Officer
Jun Yoon
Chief Financial Officer
Recent News
2026-02-06
2026-02-04
Company data provided by crunchbase