Senior Scientist - Clinical Bioanalysis

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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. This Role Might Be for You if You: Possess significant experience in ensuring the quality of documentation and data. Are knowledgeable about immunology and have experience with bioanalysis assays such as ELISAs or MSD chemiluminescent assays. Are a strong collaborator and communicator that can work cross-functionally to achieve group and departmental objectives. Have 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. To be considered for this position , you must have a BS or MS degree with 8+ years of relevant post-degree experience or a PhD with 0-3 years of relevant post-degree experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.

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