Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:Labeling and Packaging Scientist - Technical Services/Manufacturing Scientist (TS/MS) role will initially support the delivery of the gene therapy drug product labeling and packaging operations, specifically regarding technical transfer and process validation internally and externally. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the labeling and packaging processes at the LP2 site.
Key Objectives/Deliverables:- Understand the scientific principles required for labeling and packaging of drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
- Provide technical oversight for labeling and packaging materials.
- Provide labeling and packaging technical support to operations with respect to materials, equipment, and processes.
- Lead technical evaluations and specific problem resolution, including troubleshooting and root cause analysis.
- Lead risk assessments of labeling and packaging operations and material suppliers.
- Provide technical support for all start-up activities (e.g., tech transfer, process validation).
- Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.
- Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
- Support and/or own the technical agenda for the product or validation process.
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Serve as technical interface external to the LP2 site.
- Provide audit support, as needed.
- Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
- Collaborate with and influence partners across global packaging sites and teams along a specific product supply chain.
- Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Requirements:- B.S. engineering, packaging science, or related field
- 3+ years experience in a manufacturing organization focusing on labeling and packaging
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences:- Pharmaceutical labeling and packaging manufacturing experience
- Root cause investigation experience
- Proven ability to work independently or as part of a team to resolve an issue.
- Strong attention to detail.
- Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.
- Knowledge and understanding of manufacturing processes
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
Additional Information:- Off-hours support may be needed, by request.
- Required to respond, off shift, to operational issues.
- Minimal travel required.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$67,500 - $173,800
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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