Senior Scientist

We are seeking a Scientist to join our Analytical Method Development team. In this critical role, you will serve as a Subject Matter Expert (SME) in analytical method transfer and validation, supporting the development and quality control of lipid nanoparticles (LNPs). You will also play a key role in continuous improvement initiatives and provide technical leadership in investigations and root cause analyses.

Please note: This role will eventually need to relocate to North Dakota. Relocation assistance is available.

Key Responsibilities:

• Act as SME for analytical method transfer and validation.
• Support method and process validation activities.
• Contribute to QC testing and development for lipid nanoparticles (LNPs).
• Lead or support investigations into deviations, OOS results, and CAPAs.
• Drive continuous improvement in analytical methodologies and lab practices.
• Mentor and support the development of junior scientists.

Required Skills & Expertise:

• Strong experience in analytical chemistry, method development, and quality control.
• Hands-on experience with HPLC, capillary electrophoresis, PCR, and protein assays.
• Proficiency in ELISA, protein chemistry, and regulatory compliance (e.g., FDA guidelines).
• Demonstrated ability to troubleshoot and optimize analytical methods.

Qualifications:

• PhD in a relevant scientific discipline with5+ years of experience, or
• Master’s degreewith7+ years, or
• Bachelor’s degreewith10+ years of relevant experience.
• Proven experience mentoring junior team members is highly desirable.

Work Environment:

• 100% onsite role, Monday–Friday, 9:00 AM – 5:00 PM.
• Individual contributor role with mentoring responsibilities.
• Reports to the Sr. Manager of Method Validation.
• Collaborative team environment with nine scientists.