Principal Scientist

Location: Tarrytown, NY. Work model: 4 days onsite.

About the role

The Bioanalytical Sciences group is seeking a Principal Scientist to serve as the Bioanalytical Sciences Lead, managing bioanalytical strategy and overseeing bioanalytical activities for clinical programs. The role acts as the liaison between Bioanalytical Sciences (BAS) and clinical study teams to manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables and timelines, and supports regulatory submissions.

Responsibilities

• Serve as the Bioanalytical Sciences Lead on clinical study teams and participate on internal and external project teams to oversee bioanalysis for clinical studies.
• Develop and manage bioanalytical strategy, including immunogenicity risk assessment, assay selection, and sampling timepoints for clinical programs.
• Act as liaison between BAS and the clinical development team, collaborating with Clinical Pharmacology, Regulatory Affairs, clinical study teams, and other groups to establish bioanalytical deliverables and timelines for multiple projects.
• Review sample analysis documentation and clinical sample analysis reports.
• Contribute to regulatory submissions and respond to regulatory inquiries.
• Review and contribute to clinical study documents such as expanded synopses, protocols, amendments, statistical analysis plans, and clinical study reports.
• Review data, SOPs, publications, and guidelines to ensure bioanalysis is compliant with industry practice and regulatory expectations.
• Prepare and present scientific data at internal and external meetings.

Qualifications

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

Skills

• Proficiency in bioanalytical assay development and execution.
• Ability to assess immunogenicity risk and select appropriate assays.
• Expertise in data review, SOP compliance, and regulatory guidance interpretation.
• Effective presentation of scientific data to diverse audiences.
• Collaboration across multidisciplinary teams.

Benefits

• Competitive total rewards package.
• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, including 401(k) company match.
• Health and wellness programs, fitness centers.
• Comprehensive insurance benefits (medical, dental, vision, life, disability).
• Paid time off.
• Family support benefits.
• Inclusive workplace culture.

Pay

Salary range (annually): $128,600 – $210,000.

Schedule

Work model/flexibility: 4 days onsite.