Director/Sr. Director, Late-Stage LNP Process Development

BioSpace; Boston (MA); On-site; USD 168,000 - 246,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Vacation benefits

Job summary

Lilly is seeking a Director/Sr. Director for Late-Stage LNP Process Development in the U.S. This role partners with multiple teams to advance RNA-LNP drug products through late-stage development and into Phase 3-ready manufacturing for commercialization.

The candidate will drive process development, characterization, and analytical methods, while coordinating with Tech Transfer and Manufacturing for smooth scale-up and transfer to partners. Strong regulatory interaction experience is a plus.

Qualifications

• PhD in engineering, chemistry, molecular biology or related field.
• 10+ years of relevant industry experience.
• RNA-LNP process development, scale-up, and tech transfer experience.
• Solid understanding of ICH guidelines and cell/gene therapy best practices.
• Excellent problem-solving skills with ability to influence scientific direction.

Responsibilities

• Establish technical roadmap for Late-Stage LNP Process Development.
• Drive process development, optimization, scale-up, characterization, and understanding for late-stage programs.
• Partner with Early-Stage LNP and Analytical Development on scale-up strategy and risk mitigation.
• Develop Phase 3 ready manufacturing processes and transfer to internal/external partners.
• Define product requirements and site selection for Phase 3/commercial manufacturing.
• Lead development and qualification of analytical methods and testing programs.

Skills

RNA-LNP dev

Process leadership

Problem solving

Influence direction

Education

PhD in engineering, chemistry, or biology

Job description

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

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

We are seeking a highly motivated candidate for the position of Director/Sr. Director, Late-Stage LNP Process Development. The individual will partner with the following teams - Early-Stage LNP, Tech Transfer and Manufacturing, LNP Platform Innovation, Analytical Development - as well as the broader Delivery Devices and Connected Solutions team, and cross functionally with Bioproduct Research and Development to advance Lilly's transformative pipeline. The successful candidate will combine deep scientific expertise, operational excellence, and a passion for tackling new challenges in a fast-paced, dynamic environment.

Key Responsibilities

• 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.

Basic Qualifications

• PhD in engineering, chemistry, molecular biology, or a related field with 10+ years of relevant industry experience.
• Demonstrated experience in RNA-LNP process development, scale-up, and tech transfer.
• Proven experience in phase-appropriate assay development, optimization, 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.

Additional Skills And Preferences

• Experience advancing complex parenteral products from clinical to BLA/NDA regulatory submission is highly preferred
• Prior experience authoring regulatory submission documents and supporting health authority interactions
• Sound understanding of statistics and data management

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 $168,000 - $246,400.

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.

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