Senior/ Principal Scientist, LNP Analytics

Role Summary

Senior Scientist/Principal Scientist to join Analytical Development for LNP delivered in vivo therapeutics. Contribute to method development for LNP and related modalities, working hands-on and with CROs, bringing deep understanding of analytical methods, regulatory requirements, and problem-solving in a fast-paced environment.

Responsibilities

• Hands-on development, execution and troubleshooting of analytical assays to characterize and quantify LNPs and related materials.
• Design, perform, and provide guidance for method development, optimization, troubleshooting, feasibility, transfer, and qualification of analytical methods for internal and external stakeholders.
• Spearhead evaluation and adoption of new technologies and new analytical methods.
• Serve as technical lead and subject matter expert for analytical projects at CMOs/CROs ensuring scientific rigor and regulatory compliance.
• Provide analytical expertise for comparability studies to support manufacturing process changes and product lifecycle management.
• Author and review SOPs, analytical protocols, technical reports, and regulatory submission documents (e.g., IND, BLA).
• Apply biochemical and biophysical analytical techniques including FFF-MALS, nFCM, NTA, CE, Chromatography, Mass Photometry, etc. relevant to LNP DS and DP.
• Interpret and present complex analytical data with clarity to internal stakeholders and regulatory agencies.
• Mentor and/or supervise junior scientists, providing guidance on experimental design and career development.
• Collaborate cross-functionally with Research, Process Development, Quality, and Regulatory teams to support program advancement from early development through clinical and commercial stages.
• Foster a culture of resilience, collaboration, and entrepreneurial thinking.

Qualifications

• PhD in Biochemistry, Molecular Biology, Analytical Chemistry, or related discipline with:
  • Senior Scientist: 5+ years of relevant industry experience, or non-PhD and 12+ years progressive, relevant experience.
• Proven expertise in developing, troubleshooting, and executing assays for LNP or related products.
• Strong understanding of in vivo gene therapy delivery platforms.
• Advanced analytical and data analysis skills.
• Experience working with external laboratories (CMOs/CROs) for method development and stage-appropriate validations.
• Understanding of regulatory and compendial expectations (e.g., ICH, USP/Eur.Ph.) for mRNA and for analytical methods.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a dynamic, matrixed environment.
• Scientific curiosity and creativity.

Preferred Qualifications

• Prior experience with analytical support for regulatory filings (e.g., IND, IMPD, BLA).
• Familiarity with platform analytical approaches for mRNA therapeutics and LNP-formulated Cell and Gene Therapy products.
• Experience with liquid handler platforms and method automation.
• Demonstrated ability to lead cross-functional initiatives or technical teams.
• Passion for science, high level of integrity, and a proactive mindset aligned with collaboration, resilience, and entrepreneurship.

Skills

• Analytical method development and troubleshooting
• LNP and in vivo gene therapy analytical approaches
• Data analysis and interpretation
• Regulatory documentation (SOPs, protocols, technical reports, IND/BLA)
• Cross-functional collaboration and leadership

Education

• PhD in Biochemistry, Molecular Biology, Analytical Chemistry, or related discipline

Additional Requirements

• Manufacturing and lab positions on-site