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Research Scientist, Biologic Product Development
2 months ago
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.
- Ph.D./MSc/BS 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.
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