Process Development Senior Scientist - Attribute Sciences (Biotechnology)

Location: Cambridge, Massachusetts, United States

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for critical quality attributes and process characterization.
• Support comparability assessments, investigations, and control-strategy development for biologics.
• Lead late-stage protein characterization, structural elucidation, and forced-degradation studies using high-resolution LC/MS.
• Build automation-ready analytical workflows covering sample preparation, instrument integration, data processing, and report generation.
• Interpret complex analytical data and author or review analytical methods, protocols, reports, and CMC sections for IND and BLA submissions.
• Provide analytical subject-matter expertise and technical guidance to cross-functional partners.

Requirements

• Doctorate degree, or a master's degree with at least two years of scientific experience, or a bachelor's degree with at least four years of scientific experience.
• At least three years of pharmaceutical process development experience with analytical support, method execution, and investigational testing.
• Deep expertise in analytical method development and structural and physicochemical characterization of biologics, including monoclonal antibodies, fusion proteins, and antibody-drug conjugates.
• Strong LC/MS expertise in bottom-up peptide mapping, disulfide mapping, intact mass analysis, sample preparation, artifact control, and MS/MS data interpretation.
• Experience with Thermo Orbitrap platforms, including maintenance, calibration, and troubleshooting, plus laboratory automation using liquid handlers, pipetting robots, and automation software.
• Experience authoring and reviewing regulatory submissions, especially Module 3 quality sections for IND and BLA submissions, with strong written and verbal communication skills.

Nice to have

• Experience with Chromeleon and Biopharma Finder.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off, work-life balance support, and career development opportunities.
• Flexible work models where applicable to the role.