Advisor, Technology Transfer & Process Engineering

Role Summary

Advisor, Technology Transfer & Process Engineering at Lilly/Verve Therapeutics, contributing to tech transfer and manufacturing of gene editing products. The role focuses on RNA process development, tech transfer, and GMP manufacturing, facilitating drug product tech transfer efforts and enabling successful clinical manufacturing by external vendors. The position involves on-site manufacturing support, collaboration across functions, and communication of technical aspects to internal and external stakeholders. Location is onsite in Indianapolis, IN or Boston, MA with travel as required.

Responsibilities

• Drive technical readiness and on-site support for manufactures of mRNA and gRNA across early-stage and late-stage programs, including batch record writing/review, process scale-up, data trending, and quality activities (change controls, deviation investigations, process improvements).
• Oversee on-site manufacturing campaigns at CMOs, troubleshooting in coordination with CMOs and internal stakeholders; travel to manufacturing sites required.
• Lead transfer efforts of active clinical processes to secondary vendors to strengthen supply chain robustness.
• Coordinate with Supply Chain to source key components and raw materials for a 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 reviews of GMP documents including tech transfer reports, SOPs, technical protocols, batch records, and campaign summaries.
• Write technical reports and contribute to global regulatory filings in support of clinical development.

Qualifications

• 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 communicate risks and impacts to peers and management.
• Required: Knowledge of GMP compliance around drug substance and drug product manufacturing; understanding differences between early-stage and late-stage programs.
• Required: Attention to detail, data/reports analysis, and troubleshooting abilities.
• Required: Initiative to meet project timelines and deliverables; problem-solving skills.
• Required: Domestic and international travel; approximately 25% travel.
• Preferred: Additional experience with enzymatic reactions.
• Preferred: Chromatography process development experience.
• Preferred: Plasmid production experience.

Skills

• Process chromatography design and optimization
• GMP-compliant manufacturing knowledge
• Technical documentation and report writing
• Cross-functional collaboration and stakeholder management
• Risk assessment and change management

Education

• MS in engineering or related scientific field (required)

Additional Requirements

• Travel: 10–25% travel domestically/internationally; 25% noted in role
• Hybrid schedule at Boston or Indianapolis Lilly site; onsite in Indianapolis, IN or Boston, MA