Director, Analytical Development (Small Molecule)
Structure Therapeutics
9 hours ago
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:
- 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 (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 DS, DP, Quality, Supply Chain, and Regulatory CMC teams; contribute to PPQ, tech transfers, and commercial readiness.
- Oversee analytical work at CDMOs/CROs: specifications, method development/transfer/validation, impurity control strategies, stability protocols/reports/retest/shelf-life extensions, and reference standards.
Qualifications:
- B.S. in Analytical Chemistry/Pharmaceutical Sciences/Chemistry (M.S. or Ph.D. also considered).
- 10+ years of relevant industry experience (or less with advanced degree).
- Deep expertise in small-molecule API and oral solid dose (OSD) analytical development.
- Significant regulatory dossier authorship/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.
Benefits (as stated): annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown.
Application instructions:
Apply through the official career page at BambooHR.
Travel Required: 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:
- 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 (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 DS, DP, Quality, Supply Chain, and Regulatory CMC teams; contribute to PPQ, tech transfers, and commercial readiness.
- Oversee analytical work at CDMOs/CROs: specifications, method development/transfer/validation, impurity control strategies, stability protocols/reports/retest/shelf-life extensions, and reference standards.
Qualifications:
- B.S. in Analytical Chemistry/Pharmaceutical Sciences/Chemistry (M.S. or Ph.D. also considered).
- 10+ years of relevant industry experience (or less with advanced degree).
- Deep expertise in small-molecule API and oral solid dose (OSD) analytical development.
- Significant regulatory dossier authorship/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.
Benefits (as stated): annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown.
Application instructions:
Apply through the official career page at BambooHR.
Travel Required: up to 15%, globally.