Senior Principal Engineer, Technology Transfer, Process Engineering, LNP
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • Massachusetts • United States
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Salary
💰 $66,000 - $171,600 per year
Job Level
About the role
- As Principal Engineer, Technology Transfer and Process Engineering you will have an integral role in Technical Operations contributing to tech transfer and manufacturing of Verve’s novel gene editing products
- help facilitate drug product tech transfer efforts and drive successful clinical manufacturing by external vendors
- 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
- 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
Requirements
- MS in engineering or related scientific field with 10+ years experience or BS in engineering or related scientific field with 12+ years experience
- 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
- Attention to detail, critical analysis of data/reports, and troubleshooting abilities
- Proven ability to take initiative to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met
- Domestic and international travel required (up to 25%)
- Gap assessment, relationship management, and organizational planning skills required
- Ability to clearly communicate risks and potential impacts to both peer groups and management
- Expected to be highly proficient in Excel.
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
gene editingtech transfermanufacturingbatch record writingprocess scale-upprocess data trendingGMP compliancetangential flow filtrationtroubleshootingregulatory filings
Soft Skills
attention to detailcritical analysisinitiativeproject managementrelationship managementorganizational planningcommunicationcollaborationcontinuous improvementleadership