Bioanalytical Portfolio Scientist

Amgen

. Serve as the technical subject matter expert for outsourced methods .

Posted 9/16/2026full-timeRemote • United StatesMid-LevelSenior💰 $109,020 - $147,498 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Immunoassay Development, Validation, and Troubleshooting for ADA and NAb Assays, while ensuring compliance with GLP/GCP standards and managing the method lifecycle effectively. Proven ability to collaborate with CROs and internal teams to drive results and maintain high-quality processes.

Highest-signal resume keywords

Immunoassay DevelopmentMethod ValidationRegulatory ComplianceProject ManagementCollaboration Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Immunoassay ValidationADA AssaysNAb AssaysMethod Lifecycle ManagementAnalytical Data ReviewTroubleshootingRegulatory GuidanceGLP StandardsGCP StandardsScientific Oversight

Soft Skills

Excellent Communication SkillsCollaborationNegotiationPersuasionCooperation

Industry Keywords

CRO ManagementBioanalytical StudiesSOPsProcess ManagementScientific Guidance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as the technical subject matter expert for outsourced methods
Ensure adequate method validation and optimal method performance at CROs
Provide scientific and technical oversight of outsourced bioanalytical study phases governed by GLP/GCP principles
Provide oversight of immunogenicity bioanalytical activities, including ADA and NAb assays
Lead assay transfer and validation at external CROs
Collaborate with internal bioanalytical subject matter experts on immunogenicity methods
Monitor assay performance and provide input for troubleshooting and continuous improvement
Manage the method lifecycle, including validation plans, protocols, reports, reagents, and reference materials
Review analytical data and study documentation for scientific accuracy, consistency with GLP/GCP standards, and regulatory guidance
Work with CRO cross-functional partners on issue resolution and escalation
Provide subject matter expertise during supplier evaluation and monitoring
Follow and contribute to guidance documents and SOPs
Support regulatory activities

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of regulated scientific laboratory experience OR Bachelor’s degree and 4 years of regulated scientific laboratory experience
Demonstrated expertise in Immunoassay development, validation, and troubleshooting for ADA and NAb (cell based or non-cell based) assays
Knowledge of current regulatory expectations, industry best practices, and applicable scientific guidance
Experience working with CROs
Project and people management
Process management and planning skills
Excellent written and verbal communication skills
Project and issue management skills
Ability to collaborate, negotiate, and persuade others internally and externally
Ability to promote cooperation across the organization
Ability to drive results and deliver high-quality processes and outcomes
Ability to communicate appropriately to the situation
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

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
Flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Work/life balance opportunities
Career development opportunities
Financial plans with opportunities to save towards retirement or other goals