Analytical Characterization Development Scientist - LNPs
Eurofins · Boston, MA · 3 wk ago
Analyst$37–$41/hrFull-time
About the role
The Analytical Development team at Eurofins Professional Scientific Services supports testing non-GMP samples for development studies such as comparability assessments, process development, stability, product, and process characterization. This role involves providing testing support for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
Responsibilities
- 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.
- Collect, process, and analyze experimental data, ensuring accurate and timely documentation in electronic laboratory notebooks.
- 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: 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.
Skills
- 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.
- Excellent Full-time Benefits Include.
Pay
$37.00-$41.00 per hour based on education and experience.
Schedule
Full-time, first shift, Monday-Friday with overtime as needed.