Advisor, LNP Process Development and Platform Innovation

100 Eli Lilly and Company; Boston (MA); In loco; USD 168.000 - 268.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) plan

Pension

Vacation benefits

Medical/dental/vision benefits

Flexible benefits

Descrizione del lavoro

Eli Lilly and Company in Boston seeks a scientist to advance nonviral RNA-LNP delivery platforms, focusing on process development and manufacturing readiness for clinical material.

You will build platform process tools, optimize unit operations, and collaborate across discovery, development, and external partners to accelerate portfolio assets while ensuring regulatory readiness and high-quality documentation.

Competenze

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, or related field.

Mansioni

• Drive RNA-LNP platform innovation through publications and industry collaboration.
• Develop mechanistic understanding of RNA-LNP unit operations and optimize process design.
• Transfer processes to pilot and manufacturing scales with GMP readiness.
• Author technical reports and drug product CMC sections for early-phase filings.
• Collaborate across discovery-development interfaces and with external partners.

Conoscenze

RNA-LNP formulation

Process development

Tech transfer

Documentation

Formazione

Ph.D. in Chemical Engineering

Strumenti

DLS

SAXS

cryo-TEM

SEC

HPLC

AF4

Descrizione del lavoro

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. The Advanced Delivery Systems (ADS) team, part of the Delivery Devices and Connected Solutions (DDCS) organization, is Lilly's engine for innovation and development in nonviral delivery. The organization's formulation, analytical, process, and platform capabilities span lipid nanoparticle (LNP) systems, particulate formulations, long-acting injectables, and injection physiology. The team is also investing in new delivery platforms to support a growing portfolio of genetic medicines, including RNA-based therapies and other nonviral delivery vehicles.

We are seeking a scientist with a background in nonviral delivery systems and drug products to play a dual role: driving platform innovation for next‑generation delivery systems and manufacturing processes, and supporting development efforts to advance portfolio assets. Located at the Lilly Seaport Innovation Center in Boston, this position seeks a candidate with hands‑on experience in process development of nonviral delivery vehicles, e.g., RNA‑lipid nanoparticles, along with a self‑driven, innovative mindset, creative problem‑solving skills, and the ability to collaborate effectively across diverse teams.

Roles and Responsibilities

• Drive the team's RNA‑LNP innovation agenda through publications, presentations, and industry influence.
• Build a platform process toolbox across formulations and scales, using mechanistic understanding and modeling to flag risks early and accelerate development across the Lilly portfolio.
• Develop mechanistic understanding of key RNA‑LNP unit operations, including rapid‑mixing nanoprecipitation, tangential flow filtration, conjugation, and sterile filtration, and of how process design impacts critical quality attributes such as particle size, polydispersity, encapsulation efficiency, RNA integrity, and lipid content, utilizing state‑of‑the‑art analytical techniques.
• Build process capabilities at lab, early‑phase clinical, and scale‑up scales, and evaluate and implement new manufacturing and characterization technologies for RNA‑LNP drug products.
• Advance RNA‑LNP portfolio assets from scale‑up through early‑phase clinical manufacture: mitigate scale‑up risks, support project management and technical leaders in executing complex tech transfers to internal and external manufacturing sites, support GMP readiness, and implement processes to deliver clinical trial material.
• Ensure consistent technical deliverables and documentation across RNA‑LNP transfers, including authoring technical reports and drug product CMC sections of early‑phase regulatory filings, generating supporting data, and addressing health‑authority CMC questions with support from colleagues.
• Work across the discovery‑development interface, engaging early with discovery colleagues to identify risks and accelerate the progression of candidates into development.
• Establish and leverage strategic relationships with academic and industry partners, CDMOs, and vendors to accelerate and access emerging innovation in RNA‑LNP delivery.
• Mentor and develop junior scientists, associates, and interns, and review protocols, technical reports, and development summaries.
• Ensure work meets Development Quality, regulatory, and HSE requirements, with complete and timely records.

Basic Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field.

Additional Skills and Preferences

• Prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.
• Self‑driven, highly motivated, and independent fast learner who is eager to try new techniques, stays current with the scientific literature, and thinks creatively to solve problems, while collaborating and communicating effectively across teams.
• Deep mechanistic understanding of unit operations and a solid grasp of engineering fundamentals for designing and optimizing manufacturing processes and drug delivery platforms are highly preferred.
• Experience with development and tech transfer of RNA‑LNP formulations is strongly preferred.
• Hands‑on experience working with process equipment from lab to pilot scales is preferred.
• Familiarity with routine and advanced analytical techniques used to characterize RNA‑LNPs (e.g., DLS, SAXS, cryo‑TEM, SEC, HPLC, AF4, RNA integrity and encapsulation assays) is preferred.
• Previous experience with regulatory submissions of RNA‑based therapies is preferred.
• Experience with mathematical modeling, whether mechanistic or data‑driven, is a plus.
• Experience with laboratory and scientific workflow automation, agentic AI integration, and data infrastructure (e.g., data capture, aggregation, integration, and pipelines connecting instruments, ELN/LIMS, and analytics platforms) is a plus.
• Experience with process analytical technology (PAT) and continuous manufacturing is a plus.
• Proficiency in statistics, design of experiments, data analysis, and reporting.
• Strong publication and presentation record.

Benefits

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $268,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly