Advisor, Technology Transfer – Process Engineering
Eli Lilly and Company
full-time
Posted on:
Location Type: Hybrid
Location: Indianapolis • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $129,000 - $209,000 per year
Job Level
SeniorLead
About the role
- have an integral role in Technical Operations contributing to tech transfer and manufacturing of Verve’s novel gene editing products
- facilitate drug product tech transfer efforts and drive successful clinical manufacturing by external vendors
- drive technical readiness and on-site support for manufactures of mRNA and gRNA across early-stage and late-stage programs
- 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
- 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' relevant industry experience
- Strong process chromatography experience required, across multiple modes of separation, column formats, scale-up, chromatography equipment, and column qualification
- Gap assessment, relationship management, and organizational planning skills required
- Ability to clearly communicate risks and potential impacts to both peer groups and management
- 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 (25%)
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
gene editingmRNA manufacturinggRNA manufacturingbatch record writingprocess scale-upchromatographyGMP compliancetechnical report writingregulatory filingsprocess data trending
Soft skills
relationship managementorganizational planningcommunicationattention to detailcritical analysistroubleshootinginitiativeproject managementcollaborationproblem-solving
Certifications
MS in engineering