Principal Scientist - Immunogenicity Bioanalytical Sciences

Responsibilities

• Support the design, development, validation, and implementation of assays for detecting binding and neutralizing anti-drug antibodies (ADAs & NAbs)
• Collaborate with drug development teams, research groups, and compliance to ensure suitable assay formats for therapeutic programs
• Manage the transfer of assays to global bioanalytical CROs through close coordination with outsourcing teams
• Contribute to regulatory filing documents and provide technical responses to regulatory inquiries
• Supervise or mentor laboratory staff and interact with multidisciplinary scientists across R&D

Requirements

• PhD in Biochemistry, Molecular Biology, Cell Biology, or Immunology with 2 years of industry experience
• OR Master's degree with 5 years of industry experience
• OR Bachelor's degree with 7 years of industry experience
• Expertise in immunogenicity assay development and validation
• Knowledge of GLP and GCP guidelines
• Experience with CRO assay transfer

Preferred Qualifications

• Demonstrated expertise in oversight of immunogenicity assays according to global regulatory guidelines
• Knowledge of statistical approaches applied to immunogenicity assays
• Experience with drug-tolerant and cell-based assay formats for ADA and NAb detection
• Supervisory and mentoring experience in a laboratory setting
• Ability to manage multiple projects and meet critical timelines in a matrixed environment

Benefits

• Comprehensive medical, dental, and vision coverage
• Retirement and Savings Plan with generous company contributions
• Discretionary annual bonus program and stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative human therapeutics. Since 1980, Amgen has focused on high unmet medical needs in areas such as Oncology, Inflammation, General Medicine, and Rare Disease to serve patients living with serious illnesses.