Job Description

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.

Qualifications

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.
• 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).
• Proficiency in GMP regulations and Good Documentation Practices.
• Strong 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:

• 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 Information

_ What to Expect in the Hiring Process:_

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader
• 30 Minute In-Person Onsite Meeting with the Team

_ 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 options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Annual 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.