Senior Scientist - Clinical Bioanalysis
Regeneron
16 days ago
On-site
Tarrytown, NY
Clinical Research and Development
In this role a typical day might include the following:
- Serves as PI for multiple clinical and/or nonclinical programs; oversees all study-related activities including protocol review, approval of bioanalytical data, assessing deviations, reporting data, and submitting documentation for archival.
- Coordinates run planning and resource allocation for multiple concurrent studies/programs; provides scientific guidance, makes scientific decisions, leads assay performance troubleshooting, and ensures scientific quality and regulatory compliance.
- Communicates with internal and external collaborators to ensure timely delivery of bioanalytical data and reports for internal milestones and regulatory filings (Pre-IPA, INDs, BLAs, etc.).
- Participates in and presents at sub-team/group and department meetings; contributes to posters/manuscripts; may present externally.
- Ensures compliance for laboratory work and documentation per SOPs/BMPs and regulations (e.g., GLP, GCP); corresponds with Quality Assurance Unit (QAU) regarding internal audits.
- May train on and execute bioanalytical methods for clinical and nonclinical studies where not the assigned PI.
- Provides cross-functional support, including method validation/qualification activities.
This Role Might Be For You If You
- Have significant experience ensuring quality of documentation and data.
- Know immunology and have experience with bioanalysis assays such as ELISAs or MSD chemiluminescent assays.
- Are a strong cross-functional collaborator and communicator with leadership/oversight experience.
- Anticipate and adapt to changing priorities and deliverables.
To be considered
- BS or MS with 8+ years of relevant post-degree experience, or PhD with 0–3 years.
Application instructions
- Apply now to take your first step towards living the Regeneron Way.
Benefits (U.S., if applicable)
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off/paid leaves.
- Serves as PI for multiple clinical and/or nonclinical programs; oversees all study-related activities including protocol review, approval of bioanalytical data, assessing deviations, reporting data, and submitting documentation for archival.
- Coordinates run planning and resource allocation for multiple concurrent studies/programs; provides scientific guidance, makes scientific decisions, leads assay performance troubleshooting, and ensures scientific quality and regulatory compliance.
- Communicates with internal and external collaborators to ensure timely delivery of bioanalytical data and reports for internal milestones and regulatory filings (Pre-IPA, INDs, BLAs, etc.).
- Participates in and presents at sub-team/group and department meetings; contributes to posters/manuscripts; may present externally.
- Ensures compliance for laboratory work and documentation per SOPs/BMPs and regulations (e.g., GLP, GCP); corresponds with Quality Assurance Unit (QAU) regarding internal audits.
- May train on and execute bioanalytical methods for clinical and nonclinical studies where not the assigned PI.
- Provides cross-functional support, including method validation/qualification activities.
This Role Might Be For You If You
- Have significant experience ensuring quality of documentation and data.
- Know immunology and have experience with bioanalysis assays such as ELISAs or MSD chemiluminescent assays.
- Are a strong cross-functional collaborator and communicator with leadership/oversight experience.
- Anticipate and adapt to changing priorities and deliverables.
To be considered
- BS or MS with 8+ years of relevant post-degree experience, or PhD with 0–3 years.
Application instructions
- Apply now to take your first step towards living the Regeneron Way.
Benefits (U.S., if applicable)
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off/paid leaves.