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

Lilly•Indianapolis, IN

2d•$130,500 - $211,200

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, helping ensure successful launches, reliable supply, and technical control across internal and external sites. As an individual contributor, the role works closely with Product Development, Manufacturing Operations, Quality, Supply Chain, and external manufacturing organizations. The position includes a visible technical presence on and off the manufacturing floor, mentoring junior technical associates, and escalating significant technical, quality, and supply risks with clear assessments and recommendations. The role supports technology transfer, scale-up, validation, commercial manufacturing, process monitoring, product control strategy, regulatory submissions, and lifecycle improvement. The position requires a relevant degree and substantial practical experience in parenteral, oligonucleotide, or nucleic acid drug substance or drug product development and/or manufacturing. Candidates must be legally authorized to work in the United States; Lilly does not anticipate visa sponsorship for this role. The position involves an anticipated 10–20% domestic and international travel to commercial manufacturing sites and partners, to be confirmed by leadership.

Requirements

A degree in a relevant field such as Biochemistry, Chemistry, Chemical Engineering, Biology, or Pharmaceutical Science, plus one of the following: 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.
Legal authorization to be employed in the United States.

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 experience with 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, including knowledge of material interactions 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 interpreting complex technical data, troubleshooting manufacturing issues, and communicating risks and recommendations to management.
Experience preparing, reviewing, and 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.
Strong written and oral communication skills and the ability to collaborate effectively across Development, Operations, Quality, and external manufacturing partners.
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 for commercial launch readiness.
Provide technical support for commercial LNP manufacturing, including mixing, buffer exchange, tangential flow filtration and concentration, sterile filtration, fill/finish, and frozen storage; support batch execution and process monitoring in real time.
Escalate significant technical, quality, compliance, and supply risks to TS/MS management, including risk assessments, patient and supply impact, 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 new LNP products and platforms are manufacturable and provide commercial manufacturing feedback for 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 introducing new mixing, filtration, and single-use technologies and qualifying lipid and nucleic acid raw material sources.
Mentor junior technical associates and collaborate across Development, Operations, Quality, Supply Chain, and external manufacturing organizations.

Benefits

Company bonus eligibility for full-time equivalent employees, 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, such as healthcare and/or dependent day care flexible spending accounts.
Life insurance and death benefits.
Certain time off and leave of absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
Recognition and future promotion on the Technical Ladder.