Advisor - Late Stage LNP Process Development

Advisor – Late Stage LNP Process Development

Join Eli Lilly and Company as an Advisor – Late Stage LNP Process Development to support the development of lipid nanoparticle (LNP) processes for clinical supply and late‑stage manufacturing readiness activities.

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.

We’re seeking an experienced process characterization SME to join the Late Stage LNP Process Development team. The role involves developing LNP processes to support manufacturing of ongoing clinical supply and late‑stage manufacturing readiness activities. Candidates must have significant hands‑on process characterization experience with LNP‑based drug products (preferred) or large‑molecule biologics drug products (minimum). They should have experience developing and qualifying scale‑down models, performing FMEA risk assessments, developing PC protocols, and understanding manufacturing limitations.

Proven laboratory experience with unit operations such as TFF, high‑pressure mixing, filtration, and lipid solubilization, and the ability to support in‑lab batch execution of DoE studies is required. The role will contribute to Phase 3 process lock through collaborative work with process and analytical development teams.

• 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 stakeholders 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 and 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 reviewing CMC documentation for regulatory filings.
• Review and provide وړ 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 lab safety standards.
• Ensure lab notebooks are kept updated and support equipment troubleshooting and maintenance as needed.

• PhD in a relevant scientific discipline with a minimum of 6 years industry experience or MS Degree in a relevant scientific discipline with a minimum of 8 years industry experience.
  
  Furthermore, industry experience should include 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.
• Hands‑on experience with bioprocessing unit operations such as TFF, high‑pressure mixing, filtration, and lipid solubilization, and the ability to support in‑lab batch execution of DoE type studies.
• Experience using statistical software to analyze and trend stopt huge amounts of data to guide future studies and when authoring reports.
• Background in large‑molecule or suspension‑based drug product process development, scale‑up, and GMP manufacturing.
• Strong communication skills…