We are seeking a Senior Scientist in the Process Development Team within the Formulation Development Group (FDG) of Regeneron Pharmaceuticals, Inc. (Tarrytown, NY).
This Senior Scientist position is responsible for leading and supporting activities for various gene-based (e.g. viral delivery such as AAV) and biologic (e.
g. monoclonal antibody) modalities.
A Typical Day in the Role Might Look Like :
Lead drug product process development activities via small-scale and / or at-scale models and develop scalable processes to ensure robust characterization of different unit operations (freeze / thaw, lyophilization, mixing, filtration, filling, etc.
In particular, process development challenges for gene therapy modalities may require unique process and analytical characterization and optimization efforts.
- Independently design, implement, and document process development studies to understand impact of process parameters on product quality attributes.
- Collaborate and strategically align process development plans / output with internal and external customers, including R&pD teams, Viral Production Core, Project Management, Regulatory Sciences, and Manufacturing teams.
- Routinely author and review guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites.
- Present work at group, department and cross-functional meetings, and contribute as a process development lead in drug development team meetings.
- Participate in scientific conferences and proactively search current literature to seek out, recognize, and assess existing and new technologies to facilitate efficient and robust process development within FDG.
- Demonstrate scientific excellence through reports, publications, and patents.
This Role Might Be For You If You :
- Ability to work effectively in a team environment and capacity to quickly adapt to changes in project direction.
- Demonstrated track record of publications with creative, productive, and insightful statistical-based analysis.
- Excellent oral / written communication skills and interpersonal skills to support frequent interactions with collaborators.
PhD in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related field) with 0-3 years of relevant industry working experience.
Understanding of process impact on biophysical properties of therapeutic modalities and hands-on experience with analytical instruments to characterize protein therapeutics.
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