Process Development Senior Scientist - Attribute Sciences

• 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

• Bachelor’s degree and 5 years of Scientific experience
• Master’s degree and 3 years of Scientific experience
• 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
• 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)
• 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

Experience with Chromeleon and Biopharma Finder is a plus

• 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