Advisor, Technology Transfer & Process Engineering

Role Summary

As Advisor, Technology Transfer and Process Engineering you will play an integral role in Technical Operations, contributing to tech transfer and manufacturing of our gene-editing products. The ideal candidate will have experience with RNA process development, tech transfer, and GMP manufacturing. In this highly collaborative role, you will facilitate drug product tech transfer efforts and drive successful clinical manufacturing by external vendors.

This position is onsite in Indianapolis, IN or Boston, MA, with travel to manufacturing sites required.

• Drive technical readiness and on-site support for manufactures of mRNA and gRNA across early-stage and late-stage 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. Preference for candidates familiar with early- and late-stage experience in manufacturing.
• 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 our products.

• Required:
  
  MS in engineering or related scientific field with 10+ years' relevant industry experience.
• Required:
  
  Strong process chromatography experience across multiple modes of separation, column formats, scale-up, chromatography equipment, and column qualification.
• Required:
  
  Gap assessment, relationship management, and organizational planning skills. Ability to clearly communicate risks and potential impacts to both peer groups and management.
• 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 (25%).
• Preferred:
  Additional experience with enzymatic reactions.
• Preferred:
  Chromatography process development experience.
• Preferred:
  Plasmid production experience.

• Technical documentation writing and review of GMP documents (tech transfer reports, SOPs, protocols, batch records, campaign summary reports, etc.).
• GMP manufacturing knowledge and experience with drug substance and drug product processes.
• Cross-functional collaboration and effective communication with Process Development, Formulation, Preclinical Toxicology, Analytical Development, Quality Control, Quality Affairs, and External Manufacturing.
• Troubleshooting, data analysis, and attention to data quality.
• Project management and the ability to drive tasks to completion.

• MS in engineering or related scientific field.

• Travel: 10-25% travel (domestic and/or international).
• Hybrid schedule at Boston or Indianapolis Lilly site.
• Position location:
  
  onsite in Indianapolis, IN or Boston, MA.