At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview: Verve Therapeutics, a wholly owned subsidiary of Eli Lilly, is created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve's gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-102, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease.
Responsibilities: 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. The ideal candidate will have experience with LNP process development, scale-up and tech transfer, and GMP manufacturing. In this highly collaborative role, you will 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. 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.
Basic 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.
Additional Skills/Preferences:- 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.
Additional Information:- 10-25% Travel (domestic and/or international)
- Position location: onsite based in Indianapolis, IN
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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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