Amgen · 1 day ago
Process Development Senior Scientist - Attribute Sciences
US - Massachusetts - Cambridge
Full-time
Onsite
Senior Level
$137K/yr - $165K/yr
5+ years expAmgen is a biotechnology company that focuses on serving patients living with serious illnesses. The Process Development Senior Scientist will lead protein structural elucidation and degradation studies, optimize mass spectrometry methods, and ensure data quality for regulatory filings.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead late-stage protein structural elucidation and forced degradation studies using LC/MS workflows including reduced peptide mapping, disulfide mapping, and intact mass analysis; effectively communicate results to support regulatory filings
Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods; partner with instrument vendors and application specialists as needed to ensure reliable performance, consistent data quality, and high instrument uptime
Develop, optimize, and qualify LC/MS and complementary LC-UV protein characterization methods to identify and monitor critical quality attributes; coordinate with program leads to identify and implement control strategies
Lead training, qualification, and method transfer from our process development labs to our global quality network
Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs
Design automation-ready MS workflows including sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency
Build robust, inspection-ready LC/MS data analysis and reporting workflows (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables
Qualification
Required
Bachelor's degree and 5 years of Scientific experience OR
Master's degree and 3 years of Scientific experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
Lead late-stage protein structural elucidation and forced degradation studies using LC/MS workflows including reduced peptide mapping, disulfide mapping, and intact mass analysis; effectively communicate results to support regulatory filings
Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods; partner with instrument vendors and application specialists as needed to ensure reliable performance, consistent data quality, and high instrument uptime
Develop, optimize, and qualify LC/MS and complementary LC-UV protein characterization methods to identify and monitor critical quality attributes; coordinate with program leads to identify and implement control strategies
Lead training, qualification, and method transfer from our process development labs to our global quality network
Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs
Design automation-ready MS workflows including sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency
Build robust, inspection-ready LC/MS data analysis and reporting workflows (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables
Preferred
Strong written and verbal communication skills, ability to support data-driven decision making with diverse internal and external stakeholders
5+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics, including partnering with QC and/or CMOs on method execution
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 (e.g., Q-Exactive, Exploris, Tribrids), including routine maintenance, calibration, and independent troubleshooting of common failure modes (sensitivity loss, spray instability, mass accuracy drift, carryover/contamination). Experience with Chromeleon and Biopharma Finder is a plus
Strong RP‑UHPLC expertise (reversed‑phase method development and troubleshooting) to support peptide mapping/intact workflows (gradient optimization, column selection, carryover mitigation, pressure/peak‑shape troubleshooting)
Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software
Familiarity with United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation
Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions
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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-07
Pharma Letter
2026-01-07
bloomberglaw.com
2026-01-07
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