Analytical Characterization Development Scientist - LNPs

About the role

The Analytical Characterization Development Scientist - LNPs will support testing non-GMP samples for development studies such as comparability assessments, process development, stability, product, and process characterization. They will develop and implement new analytical methods, optimize and improve current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages.

Responsibilities

• Provide testing support for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Collect, process, and analyze experimental data, ensure accurate and timely documentation in electronic laboratory notebook.
• Review, interpret, and present data within the analytical team and cross-functionally.
• Author, review, and revise technical source documents to support phase-appropriate comparability.
• Provide technical oversight to guide analytical/QC investigations, as needed.
• Actively collaborate with internal and external process development and quality teams.
• Train and mentor junior team members as needed.

Requirements

• B.S. in Analytical Chemistry, Biochemistry, Biophysics, or related field with 3-4 years of biotech industry experience utilizing HPLC, LCMS, or Capillary Electrophoresis
• Proficiency with instrumentation such as Waters and Agilent LCs.
• Proficiency with software systems such as OpenLab, Empower, and ELN (Benchling is a plus).
• Previous experience developing methods for mRNA, gRNA, LNP, or lipids in general.
• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
• Experience in assay development, qualification, validation, and transfer to GMP environments.
• Ability to balance multiple responsibilities, prioritize activities, and navigate ambiguity.
• Demonstrated learning agility, scientific problem solving, and strong written and verbal communication skills.
• Proactive, creative, and positive attitude.
• Unwavering commitment to safety protocols and procedures.

Qualifications

• Basic Minimum Qualifications:
• Strong technical background on analytical methodologies using IP-RP, IEX, and AEX.
• Experience working with various biophysical instrumentation such as GC, HIAC, and basic particle size characterization fluorescence-based assays.
• Strong understanding of SEC-MALS analytical methodology.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Compensation: $37.00-$41.00 per hour based on education and experience