Senior Principal Engineer, Technology Transfer and Process Engineering, LNP

Role Summary

Senior Principal Engineer, Technology Transfer and Process Engineering for LNP programs. Responsible for leading tech transfer and manufacturing support for Verve's gene-editing lipid nanoparticle (LNP) products. Drives technical readiness, scale-up, and GMP manufacturing, partnering with CMOs and cross-functional teams to ensure successful clinical production by external vendors. Travel to manufacturing sites will be required.

• Drive technical readiness and on-site support for manufactures of LNP programs. This includes batch record writing and executed record review, process scale-up, process data trending and support of quality activities including change controls, deviation investigations, implementation of process improvements. Lead lessons learned and continuous improvement efforts at vendor sites.
• Oversee the manufacturing campaigns (on-site) at the CMO, including troubleshooting in close cooperation with the CMO and internal stakeholders. Travel to manufacturing sites will be required.
• Lead transfer efforts of active clinical processes to secondary vendors to drive supply chain robustness.
• Coordinate with Supply Chain on sourcing key components and raw materials to support a complex global drug product manufacturing network.
• Collaborate with cross-functional teams including Process Development, Formulation, Preclinical Toxicology, Analytical Development, Quality Control, Quality Affairs, and External Manufacturing.
• Write and provide technical review of GMP documents including tech transfer reports, best practices documents, SOPs, technical protocols, manufacturing batch records, campaign summary reports, etc.
• Write technical reports and contribute to global regulatory filings to support clinical development of Verve’s products.

• Required:
  
  MS in engineering or related scientific field with 10+ years experience or BS in engineering or related scientific field with 12+ years experience.
• Required:
  
  Experience with tangential flow filtration.
• Required:
  
  Knowledge of GMP compliance around drug substance and drug product manufacturing. Understanding of differences in requirements between early-stage and late-stage programs.
• Required:
  
  Attention to detail, critical analysis of data/reports, and troubleshooting abilities.
• Required:
  
  Proven ability to take initiative to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met.
• Required:
  
  Domestic and international travel required (up to 25%).
• Required:
  
  Gap assessment, relationship management, and organizational planning skills required. Ability to clearly communicate risks and potential impacts to both peer groups and management.
• Required:
  
  Expected to be highly proficient in Excel.

• Strong preference for candidates with prior LNP process development experience, including scale-up. Candidates with AAV experience are also encouraged to apply.
• Proficient in sterile filtration and aseptic processing requirements.
• Familiar with both early- and late-stage experience in manufacturing.
• Prior experience with Six Sigma concepts.
• Proficiency in JMP or similar software.

• 10-25% Travel (domestic and/or international)
• Position location:
  
  onsite based in Indianapolis, IN