Director, LNP/TNP Drug Product Process Development

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. 

Overview:

Position Summary:

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles.

We are seeking a highly motivated engineer leader with extensive industry experience and knowledge in drug product process development of LNP and/or TNP products from nanoparticle formation to fill/finish to advance portfolio from clinical to commercialization of Lilly’s genetic medicine programs. This position is located at Lilly’s tech center, next to the headquarters in Indianapolis. This position seeks a candidate with extensive industry experience in process development of nonviral delivery vehicles, e.g., RNA-lipid nanoparticles. This candidate would collaborate across functions at Lilly’s Boston and Indianapolis sites to advance portfolio assets. If you are interested in developing novel medicine to serve patients, you should consider joining our diverse and high-performing team.

Responsibilities:

• Lead scientists to design and execute process studies to define clinical and potential commercial manufacturing process for LNPs/TNPs and other parenteral drug products. Mentor junior scientists to improve their scientific understanding and study design and execution capabilities.

• Lead the efforts to drive the process development and characterization of various new modalities, especially LNPs/TNP late-stage development, including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes and critical process parameters.

• Drive collaboration with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations and work closely with stakeholders to ensure the integration of novel excipients into CMC development timeline and appropriate pathway for regulatory submission.

• Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.

• Ensure consistency in technical deliverables and documentation across transfers.

• Cross-Functional Collaboration: Represent the product research & development organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline and key deliverables to meet the requirements for regulatory submission.

• External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.

• Innovation: Initiate and drive innovation to tackle critical LNP or new modalities process performance and product quality. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision. Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.

Basic Requirements:

• Ph.D. in Chemical Engineering, or Biomedical Engineering are required with a minimum of 7 years of industry experience directly in LNP/TNP product process development from lipid nanoparticle formation to fill/finish. Large scale process development experience from clinical to commercialization is highly preferred.

• Extensive experience and deep knowledge with process development of lipid or targeted lipid nanoparticle formulation and manufacturing process.

• Hands-on experience in designing and optimizing manufacturing processes including nanoparticle formation, purification and fill/finish.

• Strong knowledge and experience with regulatory submissions of lipid nanoparticle-based therapies is preferred.

• Strong understanding of cGMP requirements, ICH and regulatory guidelines.

Additional Information:

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment.  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in a laboratory environment.  

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Global pharmaceutical company leading in diabetes, obesity, oncology, and neuroscience treatments. Headquartered in Indianapolis, IN.

lilly.com