Director, Analytical Development (Small Molecule)
Structure Therapeutics
June 30, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
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.
Job Responsibilities
Analytical Development & Method Lifecycle Management
- Oversee development, optimization, qualification, and validation of analytical methods for drug substance (DS) and drug product (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 for oversight of release testing, stability testing, and GMP support.
- 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 dossier content review (source document tracking and data verification).
- Author/review/approve analytical development reports for marketing applications.
- Review/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.
- Support smooth transfer of projects from early-stage to late-stage development.
External Partnerships (CDMOs, CROs, Testing Labs)
- Oversee analytical work at CDMOs/CROs: specifications; method development/transfer/validation; impurity control strategies; stability protocols/reports and retest/shelf-life extensions; reference standards.
- Participate in technical due diligence for partners/acquisitions.
Qualifications
- B.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related; M.S. or Ph.D. also considered.
- 10+ years relevant industry experience (or less with 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, virtual organization.
- Strategic thinker with strong execution/decision-making; excellent communication and cross-functional influence.
Travel: up to 15% globally.
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.
Job Responsibilities
Analytical Development & Method Lifecycle Management
- Oversee development, optimization, qualification, and validation of analytical methods for drug substance (DS) and drug product (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 for oversight of release testing, stability testing, and GMP support.
- 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 dossier content review (source document tracking and data verification).
- Author/review/approve analytical development reports for marketing applications.
- Review/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.
- Support smooth transfer of projects from early-stage to late-stage development.
External Partnerships (CDMOs, CROs, Testing Labs)
- Oversee analytical work at CDMOs/CROs: specifications; method development/transfer/validation; impurity control strategies; stability protocols/reports and retest/shelf-life extensions; reference standards.
- Participate in technical due diligence for partners/acquisitions.
Qualifications
- B.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related; M.S. or Ph.D. also considered.
- 10+ years relevant industry experience (or less with 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, virtual organization.
- Strategic thinker with strong execution/decision-making; excellent communication and cross-functional influence.
Travel: up to 15% globally.