Director – Manufacturing Science (LNP Commercialization & Commercial Manufacturing Support)

Eli Lilly and Company•Us, IN

About The Position

Lilly is seeking a scientific leader for its Parenteral Product Network Technical Services/Manufacturing Science team to drive commercialization of lipid nanoparticle (LNP) drug products and provide technical support for commercial LNP manufacturing. The role is a Global Product Steward and LNP process expert, with technical ownership of LNP-based drug products from late-stage development through the commercial lifecycle. It serves as the technical link between Product Development and commercial manufacturing sites, supporting successful launches, reliable supply, and technical control across internal and external sites. This individual-contributor role works closely with Product Development, Manufacturing Operations, Quality, Supply Chain, and external manufacturing organizations. The position provides a visible technical presence on and off the manufacturing floor, mentors junior technical associates, and escalates significant technical, quality, compliance, and supply risks to management with assessments and recommended actions. The role maintains product technical knowledge and lifecycle strategy; supports technology transfer, scale-up, validation, and launch readiness; and provides technical support for commercial LNP processes, including mixing, buffer exchange, tangential flow filtration, sterile filtration, fill/finish, and frozen storage. It owns the commercial control strategy for LNP critical process parameters and quality attributes, supports continued process verification and global product assessment, and partners with Product Development to ensure new products and platforms are manufacturable. The position also contributes to regulatory submissions and inspections, and leads process improvement and lifecycle management projects, including new technologies and qualification of raw-material sources. The position requires a relevant degree and substantial practical experience in parenteral, oligonucleotide, or nucleic acid drug substance or drug product development or manufacturing. Hands-on oligonucleotide experience, working knowledge of LNP formulation and manufacturing, and experience supporting GMP commercial manufacturing are required. The position is full-time, with anticipated compensation of $130,500–$211,200, plus eligibility for a company bonus and benefits. Travel of 10–20% domestically and internationally to manufacturing sites and partners is anticipated, subject to confirmation by leadership.

Requirements

Degree in a relevant area such as Biochemistry, Chemistry, Chemical Engineering, Biology, or Pharmaceutical Science, together with one of the following experience/education combinations: PhD and 5 years of practical experience; Master’s degree and 10 years; or Bachelor’s degree and 15 years.
Practical experience must be in parenteral, oligonucleotide, or nucleic acid drug substance or drug product development and/or manufacturing.
Hands-on experience with oligonucleotide development or manufacturing, such as 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.
Legally authorized to work in the United States; the employer does not anticipate providing employment visa sponsorship.
Strong written and oral communication skills and ability to collaborate effectively across Development, Operations, Quality, and external manufacturing partners.

Nice To Haves

Direct LNP process experience, such as microfluidic mixing, mixing-process scale-up, and TFF-based downstream operations in a commercial or late-stage clinical setting.
Background in oligonucleotide processes, formulation, or analytical development, including siRNA, antisense, mRNA, or gene-editing payloads.
Analytical characterization of LNPs and nucleic acids, such as dynamic light scattering, HPLC/CE methods, encapsulation assays, and particle analysis.
Experience qualifying lipid excipients and critical raw materials, and understanding material interactions with process equipment and single-use systems.
Product stewardship experience as technical owner or product lead for a commercial or late-stage product, including authoring annual product reviews or technical risk assessments and managing multi-site process harmonization.
Demonstrated leadership, influence, and problem-solving skills, including interpreting complex technical data, troubleshooting manufacturing issues, and clearly escalating risks and recommendations to management.
Experience preparing, reviewing, or responding to global regulatory submissions such as BLAs, NDAs, or equivalents; post-approval changes; and regulatory inspections.
Working knowledge of statistical design of experiments and analysis.
Insatiable desire to learn, innovate, and challenge oneself for the benefit of patients.

Responsibilities

Serve as Global Product Steward for LNP-based drug products, with end-to-end technical accountability for process performance, product quality, and supply across manufacturing sites.
Act as the primary technical interface between Product Development and commercial manufacturing sites.
Maintain product technical knowledge and lifecycle strategy, including process history, critical material and supplier knowledge, a technical risk register, and a roadmap for robustness, capacity, and site-network improvements.
Collaborate with Product Development and manufacturing sites on technology transfer, scale-up, process performance qualification and validation, and comparability activities to support commercial launch readiness.
Provide technical support for commercial LNP manufacturing, including real-time batch execution support and process monitoring for mixing, buffer exchange, TFF, sterile filtration, fill/finish, and frozen storage.
Escalate significant technical, quality, compliance, and supply risks to TS/MS management with timely risk assessments, patient and supply impact assessments, and mitigation recommendations.
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 support manufacturability of new LNP products and platforms and provide commercial manufacturing feedback on process design, specifications, and site selection.
Author and review technical sections of global regulatory submissions, post-approval changes, and responses to regulatory questions; support inspection readiness at commercial sites.
Lead process improvement and lifecycle management projects, including introduction of mixing, filtration, and single-use technologies and qualification of lipid and nucleic acid raw-material sources.
Work across Development, Operations, Quality, Supply Chain, and external manufacturing organizations; provide a visible technical presence on and off the manufacturing floor.
Mentor junior technical associates.

Benefits

Company bonus, depending in part on company and individual performance.
Eligibility to participate in a company-sponsored 401(k).
Pension.
Vacation benefits.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
Life insurance and death benefits.
Time off and leave of absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
Employee resource groups open to all employees.