Director, Analytical Development (Small Molecule)

structuretx; South San Francisco (CA); On-site; USD 205,000 - 258,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Unlimited PTO

Winter shutdown

Job summary

Structure Therapeutics Inc. is seeking a Director of Analytical Development to lead analytical development activities supporting late‑stage development, Phase 3 programs, PPQ, commercialization, and global regulatory filings.

This role requires deep expertise in small‑molecule analytical sciences, regulatory expectations for global submissions, and cross‑functional CMC strategy to support late-stage clinical starts and regulatory inspections.

Qualifications

• BS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline; MS/PhD also considered.
• 10+ years of relevant industry experience in analytical development for small-molecule API/OSD.
• Deep expertise in analytical development and regulatory dossier defense.
• Expertise in ICH guidelines, method validation, and impurity control.
• Strong GMP QC operations and data integrity understanding.
• Ability to operate in a fast-paced, matrixed, virtual organization.
• Strategic thinker with execution and decision-making skills.
• Excellent communication and cross-functional influence.

Responsibilities

• Oversee development, 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.

Skills

Analytical Chemistry

Small-molecule API

Regulatory Submissions

ICH Guidelines

GMP QC Operations

Method Development

Cross-functional Collaboration

Project Leadership

Technical Due Diligence

Data Integrity

Education

BS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline

MS or Ph.D. considered

Tools

Analytical Method Transfer

Stability Testing

Documentation & Validation

Job description

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.

Job Responsibilities

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

• 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.

Regulatory Strategy & Submissions

• 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.

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.
• Partner with early‑stage project teams to ensure smooth transfer of projects to late‑stage development.

External Partnerships (CDMOs, CROs, Testing Labs)

• 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.

Qualifications

• 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.

Travel Required

up to 15%, globally

Compensation and Benefits

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $205K-$258K. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance‑based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Equal‑Opportunity Employer

Structure Therapeutics Inc. is an Equal‑Opportunity Employer.