Eli Lilly and Company · 2 weeks ago
Advisor - Late Stage LNP Process Development
Boston, MA
Full-time
Onsite
Mid, Senior Level
$141K/yr - $229K/yr
4+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Advisor - Late Stage LNP Process Development will focus on developing LNP processes for clinical supply and manufacturing readiness, requiring significant hands-on experience in process characterization and collaboration with various teams.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
Responsibilities
Using QbD principles, perform in-depth failure modes and effects analysis (FMEA) on LNP-based drug product process, conduct or supervise DoE-type studies 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
Partner closely with key technical stake holders in developing and authoring drug-product process characterization protocols and provide in-lab support to execute critical studies
Contribute towards locking a scaled-up, Phase 3-ready process through execution of on-going de-risking studies as well as providing technical recommendations on implementation of manufacturing control strategies
Collaborate effectively with the process and analytical teams to develop and qualify scale-down models to characterize Phase 3 process
Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings
Review and provide technical feedback on internal and external collaborators’ experimental designs and results
Participate actively in technical discussions and meetings, proactively communicate technical findings and results to stakeholders, train and support teammates as needed
Partner with members of the facilities, lab operations, and safety to maintain the highest level of safety standards within the lab
Ensure lab notebooks are kept updated and support equipment troubleshooting and maintenance as needed
Qualification
Required
PhD in relevant scientific discipline and minimum of 4 years industry experience or MS Degree in a relevant scientific discipline and minimum of 8-10+ years industry experience
Industry experience requires large molecule process characterization, LNP process development and MSAT experience
Hands-on experience successfully advancing a drug product through process characterization to inform and implement an appropriate process control strategy required
Hands-on experience with bioprocessing unit operations such as TFF, high-pressure mixing, filtration, and lipid solubilization, and be able to support in-lab batch execution of DoE type studies required
Experience using statistical software to analyze and trend large amounts of data to guide future studies and utilize when authoring reports
Background in large-molecule or suspension-based drug product process development, scale-up, and GMP manufacturing
Strong communication skills (oral and written) and the ability to thrive in a team and goal driven environment
Preferred
Experience with LNP-based drug products is strongly preferred
Use of strong interpersonal skills for collaboration
Ability to prioritize multiple activities and handle ambiguity
Benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-12
Genetic Engineering News
2026-02-12
Company data provided by crunchbase