Senior Director, RNA-LNP Late-Stage Process Development

100 Eli Lilly and Company; Boston (MA); Presencial; USD 168 000 - 246 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive benefits

Bonus potential

Resumo da oferta

Eli Lilly and Company seeks a Director/Sr. Director for Late-Stage LNP Process Development to lead scale-up, optimization, and technology transfer for Phase 3 and commercialization programs in the RNA-LNP area.

You will partner with Early-Stage LNP, Analytical Development, and Manufacturing to ensure robust processes are developed, qualified, and transferred to external partners in a fast-paced, regulated environment. A PhD with 10+ years in the field is required.

Qualificações

• PhD in engineering, chemistry, molecular biology, or a related field with 10+ years of industry experience.
• Demonstrated experience in RNA-LNP process development, scale-up, and tech transfer.
• Proven experience in phase-appropriate assay development, qualification, and transfer for lot release, stability, and product characterization from early through late-stage development.
• Solid understanding of ICH guidelines and industry best practices for cell and gene therapies.
• Excellent problem-solving skills with the ability to influence scientific direction and drive scientific excellence across stakeholders.

Responsabilidades

• Establish the technical roadmap for the Late-Stage LNP Process Development team.
• Drive the process development, optimization, scale-up, process characterization, and process understanding activities for the late-stage LNP Drug Product programs.
• Partner with the Early-Stage LNP Process Development and Analytical Development teams to develop the scale up and comparability strategy and mitigate risks during scale-up.
• Develop Phase 3 ready manufacturing processes and partner with the Tech Transfer and Manufacturing team to transfer the process to late-stage internal and external manufacturing partners for Phase 3 and commercialization.
• Establish and execute process characterization strategies and activities to prepare for commercial process lock.
• Define product/product requirements and capacity needs for the Phase 3 and commercial processes and assist in the selection of the Phase 3/commercial manufacturing site.
• Lead development, optimization, and pre-qualification of analytical methods; and build characterization, release, stability, and comparability testing programs across drug substance, process, formulation, and finished product.
• Drive innovative process solutions for robust production of RNA-LNP products including tLNP.
• Author and review technical reports and relevant sections of regulatory submissions, and participate in regulatory interactions as needed.
• Identify external collaborations to enhance internal capabilities and drive process innovation, and represent the company at scientific meetings and industry forums.

Conhecimentos

RNA-LNP process development

Scale-up

Tech transfer

Analytical method development

Regulatory submissions experience

Problem-solving

Formação académica

PhD in engineering, chemistry, molecular biology, or related field

Descrição da oferta de emprego

Eli Lilly and Company seeks a Director/Sr. Director for Late-Stage LNP Process Development to lead scale-up, optimization, and technology transfer for Phase 3 and commercialization programs in the RNA-LNP area.

You will partner with Early-Stage LNP, Analytical Development, and Manufacturing to ensure robust processes are developed, qualified, and transferred to external partners in a fast-paced, regulated environment. A PhD with 10+ years in the field is required.