Regeneron

Healthcare

SeniorScientist-ClinicalBioanalysis

$110–179k Tarrytown, New York, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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