Principal Scientist - Immunogenicity Bioanalytical Sciences

About the role

The Pharmacokinetics & Drug Metabolism and Bioanalytical Sciences (PKDM-BA) organization is seeking to fill a Principal Scientist position in our Immunogenicity Bioanalytical Sciences (IGBA) group. In this vital role, you will support the design, development, validation, and implementation of assays for the detection of binding and neutralizing anti-drug antibodies (ADAs & NAbs) for Amgen's large molecule/protein therapeutics to support GLP preclinical and regulated clinical studies.

Responsibilities

• Support the design, development, validation, and implementation of assays for the detection of binding and neutralizing anti-drug antibodies (ADAs & NAbs)
• Collaborate with representatives from the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program
• Work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs
• Contribute to regulatory filing documents and provide responses to questions received upon regulatory review
• Supervise or mentor laboratory staff
• Analyze and interpret data to assist in assay development, validation, and troubleshooting
• Manage multiple projects and multi-disciplinary interactions with scientists across research and development at Amgen

Requirements

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field [and relevant post-doc where applicable] and 2 years of scientific/technical industry experience
• OR Masters degree and 5 years of scientific/technical industry experience
• OR Bachelors degree and 7 years of scientific/technical industry experience
• Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines
• Experience of working under the Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines
• Experience in the transfer of immunogenicity assays to bioanalytical CROs
• Knowledge of statistical approaches applied to immunogenicity assays
• Knowledge of drug-tolerant assay formats for ADA and NAb detection
• Knowledge of cell-based assay formats for NAb detection
• Knowledge of predictive immunogenicity methods using cell based or ligand binding methods
• Supervisory and mentoring experience in a lab setting
• Ability to analyze and interpret data to assist in assay development, validation, and troubleshooting
• Ability to multi-task and manage multiple projects, strong verbal and written communication skills with a high degree of motivation, creativity and collaborative qualities
• Previous experience working in a matrixed environment to implement immunogenicity assay development, validation, and sample analysis
• Project management skills to meet critical timelines associated with various activities necessary to support nonclinical and clinical studies
• Ability to collaborate with cross-functional teams while also working independently

Qualifications

• Bachelor's Degree in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field
• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field [and relevant post-doc where applicable]
• Master's Degree in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field
• Relevant Post-Doctoral Training in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field
• Minimum of 2 years of scientific/technical industry experience
• Minimum of 5 years of scientific/technical industry experience with a Master's Degree
• Minimum of 7 years of scientific/technical industry experience with a Bachelor's Degree

Skills

• Expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines
• Experience of working under the Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines
• Experience in the transfer of immunogenicity assays to bioanalytical CROs
• Knowledge of statistical approaches applied to immunogenicity assays
• Knowledge of drug-tolerant assay formats for ADA and NAb detection
• Knowledge of cell-based assay formats for NAb detection
• Knowledge of predictive immunogenicity methods using cell based or ligand binding methods
• Supervisory and mentoring experience in a lab setting
• Ability to analyze and interpret data to assist in assay development, validation, and troubleshooting
• Ability to multi-task and manage multiple projects, strong verbal and written communication skills with a high degree of motivation, creativity and collaborative qualities
• Previous experience working in a matrixed environment to implement immunogenicity assay development, validation, and sample analysis
• Project management skills to meet critical timelines associated with various activities necessary to support nonclinical and clinical studies
• Ability to collaborate with cross-functional teams while also working independently

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Full time