Advisor/Sr Advisor/Director – Manufacturing Science (LNP Commercialization & Commercial Manufacturing Support)

Responsibilities

• Serve as Global Product Steward for LNP-based drug products, holding end-to-end technical accountability for process performance, product quality, and supply across all manufacturing sites.
• Maintain the product technical knowledge base and lifecycle strategy, including process history, critical material and supplier knowledge, a product technical risk register, and a roadmap for robustness, capacity, and site-network improvements.
• Collaborate with product development and manufacturing site for technology transfer, scale-up, process performance qualification/validation, and comparability activities to support commercial launch readiness.
• Provide technical support for commercial LNP manufacturing (e.g., microfluidic or impingement mixing, buffer exchange, tangential flow filtration/concentration, sterile filtration, fill/finish, and frozen storage), including real-time support of batch execution and process monitoring.
• Escalate significant technical, quality, compliance, and supply risks to TS/MS management with risk assessments, impact to patients and supply, and recommended mitigation plans.
• Own the commercial control strategy for LNP critical process parameters and critical quality attributes, and maintain process understanding through continued process verification, stability and batch trending, and global product assessment.
• Partner with Product Development to ensure manufacturability of new LNP products and platforms, and to provide commercial manufacturing feedback that informs process design, specifications, and site selection.
• Author and review technical sections of global regulatory submissions, post-approval changes, and responses to regulatory questions, and support inspection readiness at commercial sites.
• Lead process improvement and lifecycle management projects, including introduction of new mixing, filtration, and single-use technologies and qualification of lipid and nucleic acid raw material sources.

Basic Qualifications

• A degree in a relevant area such as Biochemistry, Chemistry, Chemical Engineering, Biology, or Pharmaceutical Science with one of the following: PhD degree with 5 years of practical experience in parenteral, oligonucleotide, or nucleic acid drug substance or drug product development and/or manufacturing, or Master degree with 10 years of practical experience, or Bachelor degree with 15 years of practical experience.
• Hands-on experience with oligonucleotide development or manufacturing (e.g., synthesis, purification, formulation, characterization, or process development).
• Working knowledge of lipid nanoparticle formulation and manufacturing processes.
• Experience supporting GMP commercial manufacturing, including technology transfer, process validation, and/or deviation investigation and resolution.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences

• Direct LNP process experience, such as microfluidic mixing, scale-up of mixing processes, and TFF-based downstream operations in a commercial or late-stage clinical setting.
• Background in oligonucleotide (e.g., siRNA, antisense, mRNA, or gene-editing payload) process, formulation, or analytical development.
• Analytical characterization of LNPs and nucleic acids (e.g., dynamic light scattering, HPLC/CE methods, encapsulation assays, and particle analysis).
• Experience with lipid excipient and critical raw material qualification, and the interaction of materials with process equipment and single-use systems.
• Product stewardship experience, such as serving as technical owner or product lead for a commercial or late-stage product, authoring annual product reviews or technical risk assessments, and managing multi-site process harmonization.
• Demonstrated leadership, influence, and problem-solving skills, including the ability to interpret complex technical data, troubleshoot manufacturing issues, and clearly escalate risks and recommendations to management.
• Preparation, review, and response to global regulatory submissions (e.g., BLAs, NDAs, or equivalent), post-approval changes, and support of regulatory inspections.
• Working knowledge of statistical design of experiments and analysis.
• Strong written and oral communication skills, with the ability to collaborate effectively across Development, Operations, Quality, and external manufacturing partners.