About this role
This non-laboratory role is responsible for reviewing and evaluating analytical quality data for LNP formulations and lipid materials across stability studies, method development, and investigations. The role requires attention to detail, familiarity with GMP practices, and the ability to ensure data integrity and regulatory compliance.
Review analytical data packages from stability studies, method development, and investigations for LNP and lipid-based products.Evaluate OOS/OOT investigation reports for completeness, scientific soundness, and appropriate corrective actions.Verify calculations, data transcriptions, and chromatographic data for accuracy and compliance.Ensure documentation adheres to GMP and applicable regulatory guidelines.Maintain review timelines and tracking logs to support release and regulatory submission deadlines.Partner with analytical and quality teams to resolve data discrepancies and review findings. Minimum Required Qualifications:
B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3-4 years of analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.Proficiency in GMP regulations and Good Documentation Practices.Understanding of how chromatography is operated and how to interpret the dataStrong organizational skills, attention to detail, and accuracy in documenting results.Strong time management and multitasking abilities.Ability to work independently and collaborate in a cross-functional environment.Effective communication and documentation skills.Preferred Qualifications:
Experience with chromatograms and the ability to interpret chromatographic data such as HPLC, UPLC, and LC-MS (experience with chromatography data review is a plus).Familiarity with LNP and lipid technologies and investigations.Experience with method development.Experience with software systems such as SLIM, Veeva, JMP, and LIMS.Authorization to work in the United States indefinitely without restriction or sponsorship Additional 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.