Associate Director to Director, LAI Formulation

Job Title: Associate Director to Director LAI Formulation

Report To: VP of LAI Formulation

Location: Shanghai China

About Us:

Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys 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 clinicalstage 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:

The Director/Associate Director LAI Formulation Development in CMC will provide scientific and strategic leadership for long-acting injectable (LAI) formulation development in a fast-paced biotech environment. Leads LAI formulation strategy from early discovery through clinical development while managing and integrating external CRO and CDMO partners to ensure timely high-quality execution. Serves as a key cross-functional leader partnering closely with Discovery API DMPK Safety Assessment Regulatory and Clinical teams to align LAI formulation design with pharmacokinetic targets safety considerations and clinical and regulatory objectives. Drives CMC strategy risk mitigation and technical decision-making to advance differentiated LAI therapies efficiently.

Job Responsibilities:

• Translate discovery and nonclinical learnings (PK/PD safety bioavailability) into LAI formulation design and development decisions.
• Lead long-acting injectable (LAI) formulation development from early discovery through clinical development including formulation design optimization and characterization.
• Manage and oversee external CRO and CDMO partners including study design technical oversight timelines budgets and deliverables. Ensures that CROs and CDMOs maintain compliance with cGMP GCP FDA ICH guidelines SOPs and NMPA regulations.
• Guide the formulation scientists to develop prototype LAI formulations in internal lab.
• Author review and contribute to CMC and regulatory documentation including IND/CTA sections briefing documents and responses to regulatory questions.
• Master in LAI technologies and industry best practices applying innovation where appropriate to advance pipeline programs. Explores and evaluates the external LAI formulation technologies globally to support internal projects
• Proactively participates in team activities as an excellent team player contributes to project deliverables.
• Working Language required: English

Qualifications:

• Ph.D. in Chemistry Biochemistry Pharmaceutical Sciences or a related scientific discipline.
• 10 years of experience in drug product (DP) development within the biotech and/or pharmaceutical industry.
• Deep knowledge and experience in cGMP GCP ICH and requirements form different regulatory agencies.
• A proven track record in LAI formulation development and deliverables for small molecules or peptides from all stages of development.
• Detail-oriented. Familiar with manufacturing facilities and sourcing strategy for DP. Ability to critically evaluate formulation related data from a broad range of scientific disciplines.
• Experience in working with and managing CROs and CDMOs to deliver projects in time with high quality
• 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.
• Strong interpersonal skills seasoned ability to influence responsiveness a high level of attention to detail and excellent team player.
• Collaborative approach with excellent relationship building and influencing abilities.

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 candidates 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.

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Required Experience:

Director