Principal Scientist - Bioanalytical Sciences

BioSpace; Village of Tarrytown (NY); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron's Bioanalytical Sciences group in Tarrytown, NY, is seeking a Principal Scientist to lead bioanalytical strategy and oversee activities for clinical programs. You will liaise with BAS and clinical study teams to manage PK, immunogenicity, and biomarker deliverables and timelines.

You will contribute to regulatory submissions and ensure bioanalysis is compliant with regulatory expectations, preparing data for internal and external meetings and collaborating across departments.

Qualifications

• PhD or BS/MS with 5+ years of experience in immunology, pharmaceutical sciences, or related field.
• Experience with bioanalytical techniques, e.g., ELISA, ECL (MSD), LC-MS, PCR, flow cytometry, or immunogenicity assays.
• Experience with writing/reviewing scientific documents, reports, and contributing to regulatory submissions.
• Strong communication, project management, and interpersonal skills.

Responsibilities

• Serve as the Bioanalytical Sciences Lead on clinical study teams and participates on project teams both internal and external to Regeneron to oversee bioanalysis for clinical studies.
• Contributes to the development and management of bioanalytical strategy including immunogenicity risk assessment, assay selection, and sampling timepoints for clinical programs.
• Act as a liaison between Bioanalytical Sciences (BAS) and the clinical development team, work closely with groups within BAS, as well as the Clinical Pharmacology group, Regulatory Affairs, clinical study teams, and other working groups to establish bioanalytical deliverables and timelines for multiple projects.
• Review sample analysis documentation and clinical sample analysis reports.
• Contribute to regulatory submissions and responses to regulatory inquiries.
• Contribute to and review clinical study-related documents including expanded synopses, protocols, amendments, statistical analysis plan, and clinical study reports.
• Review data, SOPs, publications, and guidelines to ensure the conduct of bioanalysis is compliant with industry practice and/or regulatory expectations.
• Prepare and present scientific data at internal and external meetings.

Skills

Bioanalysis leadership

Project management

Communication

Interpersonal skills

Education

PhD or BS/MS with 5+ years in immunology/pharmaceutical sciences

Tools

ELISA

ECL

LC-MS

PCR

Flow cytometry

Job description

Build Our Future Together

Regeneron's Bioanalytical Sciences group, located in Tarrytown, NY, is looking for a Principal Scientist. In this role you will serve as the Bioanalytical Sciences Lead to manage bioanalytical strategy and oversee bioanalytical activities for clinical programs. Acts as the liaison between Bioanalytical Sciences (BAS) and clinical study teams to effectively manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables and timelines for clinical studies. Supports regulatory submissions and interactions to ensure the completeness of sections related to immunogenicity and bioanalysis of PK and target biomarker samples.

Build Our Future Together

Regeneron's Bioanalytical Sciences group, located in Tarrytown, NY, is looking for a Principal Scientist. In this role you will serve as the Bioanalytical Sciences Lead to manage bioanalytical strategy and oversee bioanalytical activities for clinical programs. Acts as the liaison between Bioanalytical Sciences (BAS) and clinical study teams to effectively manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables and timelines for clinical studies. Supports regulatory submissions and interactions to ensure the completeness of sections related to immunogenicity and bioanalysis of PK and target biomarker samples.

When & Where

• Location: Tarrytown, NY
• Work model/flexibility: 4 days onsite

Discover Your Role

• Serve as the Bioanalytical Sciences Lead on clinical study teams and participates on project teams both internal and external to Regeneron to oversee bioanalysis for clinical studies.
• Contributes to the development and management of bioanalytical strategy including immunogenicity risk assessment, assay selection, and sampling timepoints for clinical programs.
• Act as a liaison between Bioanalytical Sciences (BAS) and the clinical development team, work closely with groups within BAS, as well as the Clinical Pharmacology group, Regulatory Affairs, clinical study teams, and other working groups to establish bioanalytical deliverables and timelines for multiple projects.
• Review sample analysis documentation and clinical sample analysis reports.
• Contribute to regulatory submissions and responses to regulatory inquiries.
• Contribute to and review clinical study-related documents including expanded synopses, protocols, amendments, statistical analysis plan, and clinical study reports.
• Review data, SOPs, publications, and guidelines to ensure the conduct of bioanalysis is compliant with industry practice and/or regulatory expectations.
• Prepare and present scientific data at internal and external meetings.

This Role Requires

• PhD or BS/MS with 5+ years of experience in immunology, pharmaceutical sciences, or related field.
• Experience with bioanalytical techniques, e.g., ELISA, ECL (MSD), LC-MS, PCR,flow cytometry, or immunogenicity assays.
• Experience with writing/reviewing scientific documents, reports, and contributing to regulatory submissions.
• Strong communication, project management, and interpersonal skills.

Does this sound like you? 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.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$128,600.00 - $210,000.00