About this role
Eurofins PSS is seeking an Analytical Data Reviewer – LNP and Lipids to support analytical quality and compliance activities for lipid nanoparticle (LNP) formulations and lipid-based materials in a GMP-regulated environment.
This non-laboratory position is responsible for the detailed review and evaluation of analytical data generated from stability studies, method development activities, and laboratory investigations. The ideal candidate will possess strong analytical chemistry knowledge, experience reviewing chromatographic data, and a commitment to data integrity and regulatory compliance.
Responsibilities
Review analytical data packages related to LNP formulations, lipid raw materials, stability studies, method development, and investigations.Evaluate chromatographic and analytical data generated from techniques such as HPLC, UPLC, and LC-MS for accuracy, completeness, and compliance.Verify calculations, data transcriptions, instrument outputs, and supporting documentation.Review OOS (Out-of-Specification) and OOT (Out-of-Trend) investigations for scientific soundness, completeness, and appropriate corrective actions.Ensure all records comply with GMP requirements, Good Documentation Practices, and applicable regulatory guidelines.Maintain review timelines and tracking systems to support sample release and regulatory submission milestones.Collaborate with Analytical Development, Quality Control, and Quality Assurance teams to address data discrepancies and resolve review findings.Support continuous improvement initiatives related to data review processes and compliance practices. Minimum Qualifications
Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.3-4 years of analytical laboratory experience within a GMP-regulated pharmaceutical, biotechnology, or biopharmaceutical environment.Experience generating and interpreting chromatographic data, including HPLC, UPLC, and/or LC-MS.Working knowledge of GMP regulations, data integrity principles, and Good Documentation Practices.Strong attention to detail and ability to identify inconsistencies within analytical datasets and documentation.Excellent organizational, time management, and multitasking skills.Ability to work both independently and collaboratively within cross-functional teams.Strong written and verbal communication skills.Preferred Qualifications
Experience reviewing analytical data within a QC, QA, or analytical development environment.Familiarity with lipid nanoparticle (LNP) technologies, lipid characterization, and related investigations.Experience supporting analytical method development or method lifecycle activities.Experience with electronic systems such as Veeva, SLIMS, JMP, LIMS, or similar laboratory software platforms.Authorization to work in the United States indefinitely without restriction or sponsorship. What to Expect in the Hiring Process:
10-15 Minute Phone Interview with Region Recruiter45-60 Minute Virtual Interview with Manager and/or Group Leader30 Minute In-Person Onsite Meeting with the TeamAdditional Details:
The position is Full Time, Monday-Friday, 8am-5pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysAnnual rate is between $36.00-$40.00, depending on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.