Process Development Senior Scientist - Attribute Sciences

Role Summary

Process Development Senior Scientist - Attribute Sciences based in Cambridge, Massachusetts. Lead late-stage protein structural elucidation and LC/MS workflows; develop, optimize, and qualify LC/MS and LC-UV protein characterization methods; train and transfer methods to the global quality network; interpret analytical results and support regulatory filings.

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; communicate results to support regulatory filings.
• Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods; partner with instrument vendors and application specialists to ensure reliable performance 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 implement control strategies.
• Lead training, qualification, and method transfer from process development labs to the 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 and ensure traceability and data integrity for CMC deliverables.

Qualifications

• Required:
  • Bachelor’s degree and 5 years of scientific experience OR
  • Master’s degree and 3 years of scientific experience OR
  • Doctorate degree (PhD, PharmD, or MD) with relevant post-doctoral experience where applicable
• 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; strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation.
  • Hands-on experience with Thermo Orbitrap platforms (Q-Exactive, Exploris, Tribrids); routine maintenance, calibration, and troubleshooting; experience with Chromeleon and Biopharma Finder is a plus.
  • Strong RP-UHPLC expertise 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 and pipetting robots.
  • Familiarity with USP, ICH, and FDA guidance related to analytical method transfer and validation.
  • Experience authoring and reviewing regulatory submissions, especially module 3 (Quality) CTDs for IND/BLA submissions.

Skills

• Protein analytics
• LC/MS and LC-UV method development
• Mass spectrometry data analysis and reporting
• Analytical method transfer and validation
• Regulatory documentation for IND/BLA submissions
• Automation and data processing workflow design
• Quality control and data integrity

Education

• Doctorate degree (PhD, PharmD, or MD) with relevant post-doc where applicable
• Alternative: Master’s degree with appropriate experience; Bachelor’s degree with extensive experience