Process Development Senior Scientist - Attribute Sciences

Amgen•Cambridge, MA

30d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist - Attribute Sciences What you will do Let’s do this! Let’s change the world! This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will: 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Requirements

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]
Strong written and verbal communication skills, ability to support data-driven decision making with diverse internal and external stakeholders.

Nice To Haves

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.

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.

Benefits

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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.

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