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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 has completed
an initial public offering (IPO) in February of 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

The Executive Director of Analytical Method Development will be responsible for small molecule API and DP development for Structure Therapeutics’ CMC projects including early and late-stage programs and commercial production as well. The successful candidate will have hands on experience in analytical method development and will oversee work with various vendors and oversee analytical functions across programs. Comprehensive working knowledge of cGMP and regulatory guidance as they relate to development, testing, characterization, and shelf-life management of small molecules is paramount. This position will be accountable for design, execution, and reporting of analytical data at external CDMOs to meet regulatory requirement and company deliverables and timelines. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.

KEY RESPONSIBILITIES

• Leads and manages multiple projects simultaneously, allocates resources and coordinates project activities to facilitate the achievements of major milestones of projects to ensure required deliveries on time;

• Provides strategic, managerial, and technical leadership to the Analytical Development team.

• Designs and executes phase-appropriate analytical strategies, including method development, qualification, and validation for AAV drug substances and drug products.

• Develops and sets specifications for raw materials, intermediates, drug substances, excipients, and drug products.

• Establishes and manages stability programs for non-GMP and cGMP drug substance and drug product batches.
• Supports analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs
  
• Works in a team environment to manage drug substance and drug product analytical development activities primarily at third-party vendors including analytical method implementation, qualification/validation, and transfer for drug substance and drug product projects
  
• Reviews method validation protocols, reports, and transfer activities
  
• Reviews test data for release, stability, and characterization plans for projects
  
• Monitors stability due dates and coordinates data transfer from vendors
  
• Reviews analytical documents including but not limited to protocols, reports, and procedures
  
• Acts as the CMC team analytical representative member in cross functional developmental teams
  
• Contributes to CMC analytical aspects of regulatory filings; review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA)
  
• Serves as a technical expert and aid in analytical investigations, auditing CDMOs and providing solutions
  
• Assistances in batch record review, batch deviation investigations
  
• Authors, reviews, and delivers technical documents for regulatory submissions and publications.
  
• Ensure that CROs and CDMOs maintains compliance with cGMPs, cGLPs, FDA, EMA, ICH guidelines, SOPs, and NMPA regulations

QUALIFICATIONS:

• Minimum MS in chemistry, pharmaceutical sciences, or related field preferred; PhD preferred
  
• 15+ years of industry experience in small molecule, working in early to late-development as well as commercial production
• Strong analytical planning and resource management skills in a dynamic environment located across multiple geographies
  
• In depth knowledge of assay and related substances development, forced degradation, HPLC/UPLC, GC, KF, XRPD, residual solvents, elemental impurities, microbial testing, compendial methods. Extensive knowledge and experience in dissolution method development and validation is preferred
  
• Extensive experience in analytical development of Drug Substance and Drug Product from preclinical to commercial production
  
• Hands-on experience in carrying out stability studies for drug substance and drug product in development and/or QC settings
  
• Experience managing DS/DP stability, and knowledge of ICH stability guidelines
  
• Knowledge of compendial (USP, EP, etc) requirements and standards
  
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
  
• Strong organizational skills and attention to detail
  
• Good interpersonal and communication skills to collaborate effectively with internal and external business partners
  
• Requires a good understanding of managing groups, CMOs, CDMOs and other vendors
  
• Demonstrate a proven track record in working with and managing CROs and CDMOs for analytical method development
  
• Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
  
• Excellent team player