About Us:

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 Tech Ops Head of Drug Product, this position will be responsible for Structure Therapeutics’ small molecule Technical Operations projects in terms of the development of formulation methodology and development of robust and scalable drug product processes. This individual will support late-stage drug product activities in contract development and manufacturing organizations (CDMOs). This role will focus on Phase 3 and commercialization readiness. All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports on time to meet regulatory requirements, including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings including development reports.

Job Responsibilities:

• Develop DP process for late stage including FMEA, Qbd, PPQ and commercial readiness.
• Work with CROs to provide robust and commercially viable DP processes. Trouble shoot process variability and optimize yields
• Possess good working knowledge of oral drug delivery modalities
• Able to work with team to transition early stage DP assets to phase 3
• Manage the drug product deliverables, scope, timelines, resources on project activities so the program remains within budget, on schedule, and within scope and identify and analyze project risks and help guide teams to develop appropriate mitigation strategies.
• Work with CRO to provide all the drug product deliverables. These deliverables include the pharmaceutical developability assessment, drug product development and drug product GMP batches manufacturing.
• Work with clinical team to forecast the clinical demand and supply the IMPs on time
• Work with the project team and external consultant to support CMC submissions (e.g., INDs & NDAs). Ensure CMC sections of regulatory submissions are of high quality and completed on time.
• Manage the CROs and CDMOs. Ensure that CROs and CDMOs maintain compliance with cGMPs, FDA, ICH guidelines, SOPs, and NMPA regulations.
• Support to build the high performing CMC team. Provide proper suggestions for the team.
• Develop and manage integrated formulation/CMC timelines for all projects.
  
  

Qualifications:

• Ph. D or MS’s degree in chemistry, related field or equivalent.
• 10+ years of relevant working experience in drug product in biotech/pharma industry. Skilled in the application of cGMP is required.
• Extensive drug product development background and hands on experiences with working knowledge of chemistry, analytical or pharmaceutical science.
• Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Have both broad and in-depth knowledge as well as hands-on experience in modern analytical, formulation, and drug product techniques. Outstanding problem-solving abilities.
• Demonstrated knowledge of pharmaceutical chemistry along with the ability to troubleshoot problems.
• Basic knowledge of organic/inorganic chemistry is required.
• Demonstrate a proven track record in working with and managing CROs and CDMOs for protocol design and study execution
• 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.
• Language required: English and Chinese
  
  

Travel Required: No

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. 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, ongoing performance-based equity and various benefits offerings.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.

Fraud Alert

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Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.