Analytical Chemist - Biophysical Characterization
About The Position
Eurofins is seeking a highly skilled, passionate, and motivated scientist to join our client Analytical Development team to support testing non-GMP samples for development studies such as comparability assessments, process development, stability, product, and process characterization. The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages. Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and perform assays for characterization of complex raw materials. Review, interpret, and present data within the analytical team and cross-functionally. Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP. Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs). Author, review, and revise technical source documents to support phase-appropriate comparability. Serve as the CMC representative on cross-functional project teams. 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 .
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, Biophysics, or related field with 2-4 years of biotech industry experience or M.S. degree with 3-7 years of biotech industry experience or B.S. degree with 5+ years of biotech industry experience.
- Hands-on experience developing, qualifying and troubleshooting biophysical assays using analytical techniques such as HPLC/UPLC, MS, UV/Vis, and FTIR.
- Hands-on experience developing analytical methodologies such as IP-RP, IEX, LC-fluor, multi-modal LC, etc.
- Strong technical background on advanced characterization instrumentation such as MALS, and LC-MS NTA.
- Proficiency with 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 and LNP are a plus).
- Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.
- Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
- Experience in assay development, qualification, validation, and implementation to support target candidate validation from non-GxP to GMP environments.
- Proven track record of success collaborating effectively with cross-functional teams.
- 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.
Nice To Haves
- Strong understanding of advanced characterization technologies and data interpretations such as cryo-TEM, NMR, DLS, AUC, etc.
- Advanced understanding of lipid nanoparticle delivery, production, and purification.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Responsibilities
- Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and perform assays for characterization of complex raw materials.
- Review, interpret, and present data within the analytical team and cross-functionally.
- Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
- Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
- Author, review, and revise technical source documents to support phase-appropriate comparability.
- Serve as the CMC representative on cross-functional project teams.
- 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
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
