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Principal Investigator, Biopharmaceutical Development

4 weeks ago

Wilmington, Delaware, United States Incyte Full time
Job Summary

The Principal Research Investigator will lead the development of novel formulations and manufacturing processes for monoclonal antibodies and bispecific biologic products at Incyte Corporation.

Key Responsibilities
  • Conduct research to develop formulations, manufacturing processes, and primary container configurations for biologic products.
  • Participate in drug product development teams and contribute to the planning and execution of product development studies.
  • Design, execute, and interpret development studies based on defined project objectives.
  • Manage CRO and CMO to generate high-quality data and summarize results in technical reports, scientific papers, and presentations.
  • Interact effectively with members of the Global Biopharmaceutical Development department and cross-functional internal and external partners.
Qualifications
  • Ph.D./M.Sc./B.S. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 8 years of relevant industrial experience in formulation and drug product development of therapeutic protein products.
  • Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
  • Experience in developing optimal formulations for biological products and establishing robust process conditions for manufacturing.
  • Technical expertise in aspects of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
  • Understanding the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
  • Experience in statistical experimental design and data analysis, including Design of Experiments (DoE).
  • Experience with process characterization, validation, risk assessment, and control strategies of protein drug products.
  • Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
  • Demonstrated ability for critical thinking, problem-solving, and creativity.
  • Strong organizational and planning skills.
  • Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record, and a strong desire to learn, contribute, and collaborate.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.