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

Overview

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.
• #WeAreLilly

Preferred Qualifications

• Experience advancing complex parenteral products from clinical to BLA/NDA regulatory submission is highly preferred
• 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.