structuretx

structuretx

Director, Analytical Development (Small Molecule)

South San Francisco, California · Director

Sponsorship not specified$205k-$258kDetected 20 days ago
Supply ChainHRControlsGMPCommunication

About the role

  • 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.
  • Analytical Development & Method Lifecycle Management

Responsibilities

  • 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.
  • Perform content review of dossier sections including source document tracking and data verification.
  • Author, review, and approve analytical development reports to support marketing applications.

Requirements

  • 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.
  • 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.
  • Travel Required: up to 15%, globally
  • B.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline (M.S. or Ph.D. also considered).
  • Significant regulatory dossier authorship and defense experience.
  • Strategic thinker with strong execution and decision-making capabilities.
  • Excellent communication and cross-functional influence.
  • Structure Therapeutics Inc. is an Equal-Opportunity Employer.
  • 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.
  • Notice to Recruiters/Staffing Agencies

Compensation

  • For this role, the anticipated base pay range is $205K-$258K.

Benefits

  • 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.

Company info

  • 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 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.
  • 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.
  • 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.
  • The successful candidate will support late stage clinical starts, marketing application submissions, regulatory authority inspections, and product launch.
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