Advisor - Late Stage LNP Process Development

Eli Lilly and Company•Boston, MA

2d•$141,000 - $228,800•Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organizational Overview Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company, 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. Position Summary: We are seeking an experienced process characterization SME 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 manufacturing of on-going clinical supply and late-stage manufacturing readiness activities. The candidate must have significant hands-on process characterization experience with LNP-based drug products (preferred) or large-molecule biologics drug products (at minimum). This individual must have experience developing and qualifying scale-down models, performing FMEA risk assessments, developing PC protocols, and understanding manufacturing limitations. The candidate must have proven lab-experience with 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. This role will also contribute towards Phase 3 process lock through highly collaborative efforts with the process and analytical development teams.

Requirements

PhD in relevant scientific discipline and minimum of 6 years industry experience or MS Degree in a relevant scientific discipline and minimum of 8 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.

Nice To Haves

Experience with LNP-based drug products is strongly preferred.
Use of strong interpersonal skills for collaboration.
Ability to prioritize multiple activities and handle ambiguity.

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.

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