Regeneron
Pharmaceuticals
Sr.Scientist,DrugProductDevelopment
“Sr. Scientist, Drug Product Development at Regeneron. Skills: Drug Product Development, Lyophilization, Formulation Screening, Protein Characterization. Lead design and execution of high-throughput formulation studies. Perform HT analytical characterization”
What You'll Achieve.
Timely delivery of project milestones; Timely delivery of project objectives
Industry & Context.
Problem-solving; Address technical challenges; Troubleshooting
What They're Looking For.
Must Have
Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical and Biomolecular Engineering, or related field with 0-3 years of relevant industry experience, M.S. with 8+ years of experience, Experience with monoclonal antibodies, Experience with peptides, Hands-on experience with biochemical and biophysical techniques for protein characterization, Experience with chromatography (SE-UPLC, IEX, RP-UPLC), Experience with electrophoresis (CE-SDS, MCE, cIEF, iCE), Experience with particle size analysis (DLS, HIAC, MFI), Experience with UV-Vis, Experience with Viscosity, Experience with thermostability characterization (DSC, DSF)
Nice to Have
Expertise in lyophilization process development, Experience with statistical software (JMP) for design of experiments and data analysis, Ability to build efficient workflows for formulation screening and analytical testing, Experience with automation tools
What You'll Do.
Lead design and execution of high-throughput formulation studies
Perform HT analytical characterization
Leverage statistical tools to process large data sets
Lead development and optimization of lyophilization cycles
Perform biophysical and biochemical characterization
Support and lead process development with CMOs
Support and lead scale-up with CMOs
Support and lead technology transfer with CMOs
Support and lead troubleshooting with CMOs
Collaborate cross-functionally with PAPD
Collaborate cross-functionally with IOPS
Participate in cross-functional meetings
Contribute technical expertise in meetings
Contribute to project planning
Contribute to decision-making
Communicate effectively with stakeholders
Ensure timely delivery of project milestones
Ensure timely delivery of project objectives
Draft technical reports
Review technical reports
Draft supporting documents for regulatory filings
Review supporting documents for regulatory filings
Stay abreast of advancements in DP Development technologies
Drive innovation within the group
Identify process improvements
Implement process improvements
How You'll Work.
Team & Collaboration
Cross-functionally with colleagues; Cross-functional meetings
Communication Scope
Technical writing; Communication
Process & Methodology
Project management
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