2 дня назад
Process Development Senior Scientist (Biologics)
126 066 - 170 560$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Senior Scientist (Biologics): Developing, validating, and transferring analytical methods for monitoring critical quality attributes and characterizing biologics with an accent on high-resolution LC/MS, peptide mapping, and intact mass analysis. Focus on designing automation-ready workflows, interpreting complex analytical data, and preparing regulatory documentation for IND and BLA submissions.
Location: Cambridge, Massachusetts, United States; onsite role
Salary: $126,066.05–$170,559.95 annually
Company
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.
- Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS.
- Perform peptide mapping, disulfide mapping, and intact mass analysis for biologics.
- Build automation-ready workflows covering sample preparation, instrument integration, data processing, and report generation.
- Interpret complex analytical data and author or review technical and regulatory documentation, including CMC sections for INDs and BLAs.
- Provide analytical subject-matter expertise and technical guidance to cross-functional partners.
Requirements
- Doctorate degree, or a master’s degree with at least 2 years of scientific experience, or a bachelor’s degree with at least 4 years of scientific experience.
- At least 3 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.
- Advanced LC/MS experience with bottom-up peptide mapping, disulfide mapping, intact mass analysis, sample preparation, artifact control, and MS/MS data interpretation.
- Hands-on experience with Thermo Orbitrap platforms, including maintenance, calibration, and troubleshooting.
- Experience with laboratory automation and regulatory submissions, especially Module 3 quality documents for IND/BLA submissions.
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.
- Discretionary annual bonus program and stock-based long-term incentives.
- Award-winning time-off plans and career development opportunities.
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