Process Development Senior Scientist - Attribute Sciences

Amgen • Cambridge, MA

5d • $126,066 - $170,560 • Onsite

About The Position

This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will: Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for monitoring critical quality attributes and supporting process characterization, comparability assessments, investigations, and control-strategy development. Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS, including peptide mapping, disulfide mapping, and intact mass analysis. Establish robust, automation-ready analytical workflows encompassing sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency. Interpret complex analytical data and author or review technical and regulatory documentation, including analytical methods, protocols, reports, and CMC sections for INDs and BLAs. Provide analytical subject-matter expertise and technical guidance to cross-functional partners.

Requirements

• Doctorate degree
• Master’s degree and 2 years of Scientific experience
• Bachelor’s degree and 4 years of Scientific experience

Nice To Haves

• Three or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
• Deep expertise in analytical method development, as well as structural and physicochemical characterization of biologics, including monoclonal antibodies, fusion proteins, and protein conjugates such as antibody-drug conjugates.
• Deep LC/MS expertise in bottom-up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation.
• Hands-on experience with Thermo Orbitrap platforms, including routine maintenance, calibration, and independent troubleshooting of common failure modes. Experience with Chromeleon and Biopharma Finder is a plus.
• Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software.
• Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions.
• Strong written and verbal communication skills, with the ability to translate complex data into clear recommendations for diverse internal and external stakeholders.
• A proactive self-starter with strong problem-solving and decision-making skills who works independently, prioritizes effectively, and manages multiple complex projects through completion.

Responsibilities

• Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for monitoring critical quality attributes and supporting process characterization, comparability assessments, investigations, and control-strategy development.
• Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS, including peptide mapping, disulfide mapping, and intact mass analysis.
• Establish robust, automation-ready analytical workflows encompassing sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency.
• Interpret complex analytical data and author or review technical and regulatory documentation, including analytical methods, protocols, reports, and CMC sections for INDs and BLAs.
• Provide analytical subject-matter expertise and technical guidance to cross-functional partners.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree