Senior Engineer/Associate Principal Engineer, LNP Process Development

The Position

As a Senior Engineer/Associate Principal Engineer in the LNP Process Development team, you will have a highly visible and integral role towards the process development, scale-up, and manufacturing of Verve’s novel gene editing therapies. The ideal candidate will have experience with lipid nanoparticle process development, tech transfer, and GMP manufacturing support. In this highly collaborative and cross-functional role, you will help refine Verve’s process control and improve process understanding for multiple programs at various stages of clinical development. While you will initially serve as an individual contributor, you will mentor and train team members and cross-functional partners.

We are considering local candidates at this time.

Job Responsibilities

• Lead, design, and execute studies in the lab independently and collaboratively with other colleagues.
• Provide readouts and recommendations to cross-functional internal and external teams.
• Contribute to establishing a science-based understanding of LNP formulation and drug product filling to inform improvements to process and product quality.
• Design and contribute to scale up LNP process development experiments focused on maintaining product quality and reducing cost of goods.
• Contribute to strategic planning of GMP manufacturing campaigns, with emphasis on establishing internal readiness, coordinating with external vendors, and managing timelines and deliverables.
• Contribute to refining the technical requirements for tech transfer and process implementation at a GMP manufacturing facility, including equipment specification, draft procedures, and recommended operating parameters/ranges.
• Write and provide technical review of GMP documents including tech transfer reports, SOPs, manufacturing batch records, campaign summary reports, etc.
• Write protocols and technical reports to support clinical development of RNA-based gene editing therapeutics.
• Other duties as assigned.

Qualifications

• Senior Engineer
  • Bachelor’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 5+ years of relevant industry experience
  • Master’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 2+ years of relevant industry experience
  • Ph.D. in chemical/ biomedical engineering, chemistry, or biological sciences
• Associate Principal Engineer
  • Bachelor’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 8+ years of relevant industry experience
  • Master’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 4+ years of relevant industry experience
  • Ph.D. in chemical/ biomedical engineering, chemistry, or biological sciences with 3+ years of relevant industry experience
• Extensive knowledge of drug substance and/or drug product scale-up and manufacturing of LNPs (preferred), biologics, or nucleic acids, with a focus on mixing and TFF process scale-up.
• Extensive experience with design and selection of equipment and consumables that will be used in GMP settings.
• Knowledge of practices and equipment to run manufacturing processes in a GMP environment, including bioreactors, fermenters, mixers, TFF, sterile filtration, single-use technology, and sterile/aseptic processing.
• Highly collaborative and detail-oriented approach to facilitating the work of cross-functional teams and external vendors.
• Attention to detail, critical analysis of data/reports, and troubleshooting abilities.
• Proven ability to achieve results, keep projects on timeline, and find solutions to ensure that project deliverables are met.
• Ability to mentor and cross-train more junior scientists and engineers in performing lab-based activities.