Biotech Formulation Development Leader

6 days ago

Fatih, Istanbul, Turkey Structure Therapeutics Inc. Full time

Structure Therapeutics Inc. develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. Our 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.

We are led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. Our company has completed an initial public offering (IPO) in recent years. 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 role will develop the strategy for formulation development and lead the formulation team for drug product development to support our pipeline and provide technical guidance of drug product formulation development especially for BCS IV compounds and fixed dose combination to internal team and external collaborators. This individual will work closely with CDMOs to ensure the high-quality project delivery in time and collaborate with internal and external collaborators to bring innovative technology for formulation development. In addition, She/He will ensure robust and healthy communication with internal CMC and clinical teams including QA, QC, Regulatory Affairs, Supply Chain, Clinical Operations to fulfill Structure Therapeutics' commitment to patients and regulatory filings.

Key Responsibilities:
  1. 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.
  2. Interacts effectively with other line functions externally and internally including clinical operations, QA, QC, Supply Chain and CDMOs to align the development strategies.
  3. Develops the drug product formulation development strategy from early development through registration to support company's pipeline.
  4. Serves as the liaison to both discovery and clinical team to communicate and align on the formulation development plan and execution.
  5. Serves as an internal drug product formulation subject matter expert (SME) in various matrix team e.g compound development team (CDT) and discovery program team.
  6. Provides technical guidance to internal CMC team members on drug product formulation development and manufacturing process development.
  7. Manages and provides technical guidance to CROs and CMOs in research and development of drug products, including R&D and manufacturing at multiple CMOs.
  8. Explores and evaluates the external formulation technic innovation globally to support internal projects.
  9. Provides input on program development strategies, budgets, and timelines to ensure that both technical and business requirements are achieved.
  10. Serves as scientific or project lead on programs or projects, including due diligence assessments.
  11. Builds and maintains strong working relationships with relevant internal development and discovery functions to effectively support on-going programs.
  12. Manages all aspects of compliance issues for cGMP requirements and EHS regulations.
  13. Proactively participates in team activities as an excellent team player, contributes to project deliverables.
  14. Authors, reviews, and delivers technical documents for regulatory submissions and publications.
  15. Ensures that CROs and CDMOs maintains compliance with cGMP, GCP, FDA, ICH guidelines, SOPs, and NMPA regulations.
  16. Language required: English (plus with Chinese).

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