Senior Principal Engineer, Late Stage LNP Process Development

Posted 2 Days Ago
Be an Early Applicant
Boston, MA, USA
In-Office
114K-191K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead late-stage lipid nanoparticle process development and characterization studies, focusing on high-pressure mixing, tangential flow filtration, filtration, and lipid solubilization. Design DoE studies, identify process parameters and operating ranges, support scale-up, Phase 3 process locking, technology transfer, manufacturing readiness, technical investigations, regulatory documentation, and equipment troubleshooting. Collaborate cross-functionally and communicate technical findings while maintaining laboratory records.
Summary Generated by Built In

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. 


Organization Overview:
At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Lilly is a leader in global healthcare and has been discovering and developing medicines that help improve lives for more than 140 years. Our 50,000 employees around the world work as a team to bring breakthrough medicines to patients who need them. We are looking for motivated, highly skilled scientists and engineers to help us continue to bring breakthrough medicines to patients. 

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. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease.


We are seeking an experienced LNP Process Development Engineer to join the Late Stage LNP Process Development team within Verve. 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 in order 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.
  • Lead the design and execution of process development studies to contribute towards scaling-up and locking late stage LNP processes.
  • 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 Requirements:

  • Earned Bachelor’s degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
  • 6+ years of biotech/pharmaceutical industry experience within LNP formulation and/or process development.
  • Hands-on experience with LNP unit operations such as TFF, high-pressure mixing, filtration, and lipid solubilization.
  • Experience using statistical software (preferably JMP) to analyze and trend large amounts of data
  • Ability to use analyze and use data to guide future studies and when authoring reports.
  • Strong communication skills (oral and written) and the ability to thrive in a team and goal-driven environment.
  • Use of strong interpersonal skills for collaboration.
  • Ability to prioritize multiple activities and handle ambiguity.

Additional Skills/Preferences:

  • Earned Master's degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
  • Experience with process characterization is strongly preferred.

Additional Information:

  • Position location: Boston, MA
  • This position requires in-office/lab presence 5 days/week.

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

$114,000 - $191,400

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

Skills Required

  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or an equivalent relevant scientific discipline
  • At least 6 years of biotech or pharmaceutical industry experience in LNP formulation and/or process development
  • Hands-on experience with LNP unit operations, including tangential flow filtration, high-pressure mixing, filtration, and lipid solubilization
  • Experience using statistical software, preferably JMP, to analyze and trend large amounts of data
  • Ability to use data to guide future studies and author reports
  • Strong oral and written communication skills
  • Strong interpersonal and collaboration skills
  • Ability to prioritize multiple activities and handle ambiguity
  • Master's degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or an equivalent relevant scientific discipline
  • Experience with process characterization

Eli Lilly and Company Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.

  • Retirement Support — Feedback suggests long-term savings are bolstered by a defined-benefit pension alongside a company 401(k) match and retiree health options. These elements make total compensation feel strong beyond base salary.
  • Leave & Time Off Breadth — Feedback suggests paid time off is expansive, with substantial vacation, company shutdown days, and milestone time. This breadth of leave is viewed as a meaningful part of overall rewards.
  • Parental & Family Support — Feedback suggests family-building and caregiving support are robust, including paid parental leave, adoption or surrogacy assistance, and backup care. These programs enhance the perceived value of benefits across life stages.

Eli Lilly and Company Insights

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The Company
HQ: Indianapolis, IN
39,451 Employees
Year Founded: 1876

What We Do

Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

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