Regeneron
Healthcare
SeniorScientist-ClinicalBioanalysis
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“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
Full Job Description
Regeneron's Bioanalysis group, located in Tarrytown NY, is seeking a Sr Scientist (Principal Investigator.) **In this role a typical day might include the following:** * Serves as PI for multiple clinical and/or nonclinical programs. Responsible for the oversight of all study-related activities, including protocol review, approval of the bioanalytical data, assessing the impact of any incurred deviations, accurate reporting of data in reports and submitting documentation for archival, as appropriate. * Responsible for coordinating run planning and resource allocation for multiple concurrent studies/programs. Provides scientific guidance to laboratory staff and makes scientific decisions regarding the data. Leads initiatives to troubleshoot assay performance and oversees investigations to evaluate the validity of results, as needed. Ensures the scientific quality of the data and regulatory compliance, as appropriate. Prepares data summaries, draws appropriate conclusions, and presents data in a logical manner to cross-functional Management * Communicate with internal and external collaborators, as needed. Ensures the timely delivery of bioanalytical data and reports to support internal milestones and regulatory filings (Pre-IPA, INDs, BLAs, etc.). * Actively participates in and presents work at sub-team/group meetings. Presents data at department meetings. Contributes to posters or manuscripts. Presents posters internally and may present posters at external conferences. * Ensure compliance, as appropriate, for all laboratory work and documentation in accordance with working practices, company SOPs, bioanalytical method procedures (BMPs), and regulations (e.g., GLP and GCP). Corresponds with the Quality Assurance Unit (QAU) regarding internal audits pertinent to the study. * May train on and execute bioanalytical methods to perform bioanalysis for clinical and nonclinical studies, as needed, for studies where they are not the assigned PI. * Provides cross-functional s
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