Position Summary
- Senior Advisor, Manufacturing Science and Technology
- Manage external manufacturing activities for Orna’s proprietary lipid manufacturing and pipeline support to circular RNA and lipid nanoparticle candidates; liaison with external suppliers, logistics providers, and test/manufacturing partners.
Responsibilities
- Technical and operational management of manufacturing operations for custom raw materials (Lipids) through the development lifecycle.
- Support drug substance (DS) and drug product (DP) manufacturing for preclinical/clinical studies and enable transition to commercial supply.
- Develop and execute manufacturing strategy, goals, budgets, and operational activities to ensure timely delivery.
- Integrate internal/external activities into manufacturing operations; present plans and progress to leadership as needed.
- Manage CDMOs for manufacturing, tech transfers, investigations/OOS, and batch documentation review.
- Identify and select CDMOs for cGMP manufacture for portfolio development programs.
- Resolve timeline-critical issues, communicate impacts, and assist with mitigation plans.
- Author regulatory and technical documents for regulatory submissions for custom raw materials (Lipids); serve as regulatory SME.
Basic Requirements
- PhD/Master’s/Bachelor’s in chemistry, life sciences, engineering, or related field (PhD 6+, MS 9+, BS 12+ years relevant industry experience).
- Lipid or excipient manufacturing and scale-up experience (required).
- 7+ years manufacturing operations experience in biopharma/pharma covering RNA/LNP modalities.
- Understanding of tech transfer, cGMP manufacturing, and regulatory requirements for RNA/LNP.
- Cross-functional experience (R&D, QA, pre-clinical/safety, regulatory affairs, etc.).
- Experience authoring/reviewing early and/or late-stage regulatory filings (required).
Additional Preferences
- Leadership, entrepreneurial mindset, strong internal/external relationship building; travel as needed.
- Change management and goal-setting; strong analytical/problem-solving and attention to detail.
- Excellent oral/written communication and presentation skills.
Benefits
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program (401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being).
Travel
- ~10%.