Regeneron
Healthcare
SeniorScientistClinicalBioanalysis
“Senior Scientist - Clinical Bioanalysis at Regeneron. Skills: Clinical bioanalysis, Assay development, Data integrity, Regulatory compliance. Serve as PI for programs. Oversee study-related activities”
What You'll Achieve.
Ensure timely delivery of bioanalytical data; Ensure timely delivery of reports
Industry & Context.
Troubleshoot assay performance; Investigate validity of results
What They're Looking For.
Must Have
BS or MS degree with 8+ years of relevant post-degree experience, PhD with 0-3 years of relevant post-degree experience, Significant experience in ensuring quality of documentation and data, Experience working in a high performing team
Nice to Have
Knowledgeable about immunology, Experience with bioanalysis assays, Experience providing higher-level oversight, guidance, and leadership, Anticipates and adapts to changing priorities, Initiates action with appropriate parties
What You'll Do.
Serve as PI for programs
Oversee study-related activities
Approve bioanalytical data
Assess impact of deviations
Report data accurately
Submit documentation for archival
Coordinate run planning
Provide scientific guidance
Make scientific decisions
Lead initiatives to troubleshoot assay performance
Oversee investigations to evaluate validity of results
Ensure scientific quality of data
Ensure regulatory compliance
Prepare data summaries
Draw appropriate conclusions
Present data to management
Communicate with collaborators
Ensure timely delivery of bioanalytical data
Ensure timely delivery of reports
Participate in sub-team/group meetings
Present work at department meetings
Contribute to posters or manuscripts
Present posters internally
Present posters at external conferences
Ensure compliance for laboratory work
Ensure compliance for documentation
Corresponds with Quality Assurance Unit
Train on bioanalytical methods
Execute bioanalytical methods
Perform bioanalysis for studies
Provide cross-functional support
Coordinate method validation activities
Perform method validation activities
Coordinate method qualification activities
Perform method qualification activities
How You'll Work.
Team & Collaboration
Internal collaborators; External collaborators; Cross-functional support; Cross-functional management
Communication Scope
Present data; Communicate with collaborators; Present work; Present posters
Process & Methodology
Run planning, Resource allocation
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