Senior Scientist - Clinical Bioanalysis
About The Position
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 support to other teams or groups, as needed. Coordinates and performs method validation/qualification activities. Ensures 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.
Requirements
- Possess significant experience in ensuring the quality of documentation and data.
- Knowledgeable about immunology and have experience with bioanalysis assays such as ELISAs or MSD chemiluminescent assays.
- A strong collaborator and communicator that can work cross-functionally to achieve group and departmental objectives.
- Experience working in a high performing team, and are capable of providing higher-level oversight, guidance, and leadership.
- Anticipates and adapts to changing priorities and deliverables and initiates action with the appropriate parties, as needed.
- BS or MS degree with 8+ years of relevant post-degree experience or a PhD with 0-3 years of relevant post-degree experience.
Responsibilities
- 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 support to other teams or groups, as needed.
- Coordinates and performs method validation/qualification activities.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
