Sample Management Associate

Regeneron Pharmaceuticals • Tarrytown, GA

6d • Onsite

About The Position

A Sample Management Associate supports biobanking operations efficiently and effectively while beginning to independently lead sample data processes. Possesses a thorough knowledge and understanding of clinical/non-clinical study protocols and associated documentation. Is fully capable of multi-tasking across assignments. Works with clients directly in a team environment. The incumbent may help in assessing and investigating new opportunities that will lead to increased efficiencies and improved productivity with regards to biobanking operations. As a Sample Management Associate, a typical day may include: Trains on clinical/non-clinical study protocols and associated study documentation to build knowledge of study conduct as it pertains to biospecimen management. Executes study reference file creation by interpreting protocols and other applicable data inputs with guidance. Performs the accessioning and receipt of non-clinical/clinical samples by assessing and verifying data, both manually and with automated platforms such as Microsoft VBA and Streamlit. May identify and communicate issues with automated platforms to drive resolution. Has an in-depth knowledge of Microsoft Excel and can analyze discrepancies in sample metadata using complex formulas with limited guidance. Drives necessary operations in applicable software systems (e.g., LIMS, ELN, etc.) to perform specimen and data management. Has the ability to identify and troubleshoot routine challenges. Fulfills clinical/non-clinical sample requests to support bioanalysis deliverables as well as company-wide research initiatives. Facilitates the completion and review sample transfer documentation, as applicable. Responsible for assigning and coordinating sample management activities for assigned programs under limited guidance. Under supervision, executes the reconciliation and data cleaning of biospecimens to drive deliverables forward. May be responsible for the review of study documents to support study start up and protocol amendments. Ensures a state of audit readiness. Assists in the preparation of supporting documents for Quality Audits, as applicable. May participate in study audit activities. Provides cross-functional support to other sample management teams, as needed. May assist with the training of other laboratory staff. Participates in sub-group meetings and may shares results or progress of work with others. Responsible for his/her own safety in the laboratory, as well as for the safety of co-workers and visitors.

Requirements

• Ensure compliance and proper documentation in accordance with SOPs, and applicable regulations.
• Handle high priority and multiple tasks within the appropriate timeframe while maintaining accuracy.
• Adapts to changing priorities.
• Is capable of multi-tasking across assignments.
• Capable of identifying and troubleshooting problems pertaining to clinical/non-clinical protocols and associated documents as well as routine sample management processes and/or procedures.
• Collaborates and maintains effective verbal and written communication with internal and/or external stakeholders to facilitate data discrepancy resolution.
• Communicates with CRO’s and third-party vendors to support biospecimen operations.
• Communicates optimally with their manager and actively seeks out feedback to deepen self-development.
• Bachelor’s degree
• Typically, 2-4 years of relevant post-degree laboratory experience for Bachelor’s degree

Responsibilities

• Trains on clinical/non-clinical study protocols and associated study documentation to build knowledge of study conduct as it pertains to biospecimen management.
• Executes study reference file creation by interpreting protocols and other applicable data inputs with guidance.
• Performs the accessioning and receipt of non-clinical/clinical samples by assessing and verifying data, both manually and with automated platforms such as Microsoft VBA and Streamlit.
• May identify and communicate issues with automated platforms to drive resolution.
• Has an in-depth knowledge of Microsoft Excel and can analyze discrepancies in sample metadata using complex formulas with limited guidance.
• Drives necessary operations in applicable software systems (e.g., LIMS, ELN, etc.) to perform specimen and data management.
• Has the ability to identify and troubleshoot routine challenges.
• Fulfills clinical/non-clinical sample requests to support bioanalysis deliverables as well as company-wide research initiatives.
• Facilitates the completion and review sample transfer documentation, as applicable.
• Responsible for assigning and coordinating sample management activities for assigned programs under limited guidance.
• Under supervision, executes the reconciliation and data cleaning of biospecimens to drive deliverables forward.
• May be responsible for the review of study documents to support study start up and protocol amendments.
• Ensures a state of audit readiness.
• Assists in the preparation of supporting documents for Quality Audits, as applicable.
• May participate in study audit activities.
• Provides cross-functional support to other sample management teams, as needed.
• May assist with the training of other laboratory staff.
• Participates in sub-group meetings and may shares results or progress of work with others.
• Responsible for his/her own safety in the laboratory, as well as for the safety of co-workers and visitors.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level