Principal Engineer, Late Stage LNP Process Development

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Organization and Position Overview:

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.

We are seeking an experienced LNP Process Development Engineer to join the Late Stage LNP Process Development team. You will be joining a team that is focused on the development of LNP processes to support late-stage manufacturing readiness activities and drug product process characterization. This lab-facing role will play a critical part in advancing lipid nanoparticle (LNP) process development through characterization of key unit operations, with particular emphasis on high-pressure mixing technologies and tangential flow filtration (TFF). The ideal candidate will combine technical expertise with collaborative skills to lead and support process characterization studies and work closely with cross-functional teams. The role will also contribute towards Phase 3 process lock and supporting tech transfer and manufacturing readiness activities.

Responsibilities:

• Perform DoE-type studies to support process characterization efforts to identify critical process parameters (CPPs) and characterize appropriate normal operating ranges (NORs) and process acceptable ranges (PARs) for each parameter in each unit operation.

• Collaborate effectively with the process and analytical teams to develop and qualify scale-down models to characterize Phase 3 process.

• Contribute towards locking a scaled-up, Phase 3-ready process through execution of on-going de-risking studies.

• Support technology transfers of late-stage programs to manufacturing sites and contribute towards batch readiness activities and technical investigations as required.

• Author relevant process development and characterization reports and provide support as required in authoring regulatory documents.

• Participate actively in technical discussions and meetings, proactively communicate technical findings and results to stakeholders.

• Ensure lab notebooks are kept updated and support equipment troubleshooting and maintenance as needed.

Basic Qualifications/Requirements:

• Masters in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent) with 4-6 years of industry experience with LNP formulation and process development.

• Hands-on experience with LNP unit operations such as TFF, high-pressure mixing, filtration, and lipid solubilization.

• Experience using statistical software to analyze and trend large amounts of data to guide future studies and utilize when authoring reports.

• Strong communication skills (oral and written) and the ability to thrive in a team and goal driven environment.

Additional Skills/Preferences:

• Experience with process characterization is strongly preferred.

• Use of strong interpersonal skills for collaboration.

• Ability to prioritize multiple activities and handle ambiguity.

Additional Information:

• Position location: Boston, MA

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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.

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