Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, 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 start up the facility for both clinical and commercial supply.
This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.
Position Overview:The Manufacturing Associate will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including: Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.
Initially, the Manufacturing Associate will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Associate will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.
As a Manufacturing Associate, your responsibilities will include:- Work cross functionally with TSMS and Engineering to develop procedures, MES records, and establish operational controls.
- Work in a cleanroom environment to produce advanced therapies in a safe and quality manner.
- Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of advanced therapies.
- Participate in equipment commissioning and qualification testing and process validation activities in collaboration with other departments.
- Safely work with BSL-2 materials, following site biologics safety program.
- Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
- Utilize and monitor manufacturing equipment to ensure performance and safety standards are met.
- Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
- Provide verbal and written reports to supervisors and other teams in a clear and concise manner.
- Maintain accurate and complete electronic records and logbooks as per cGLP and/or cGMP, as appropriate.
- Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
- Compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.
- Work well in a fast-paced team environment.
Minimum Requirements:- Bachelor's degree in a STEM field.
- Or high school diploma + 5 years of relevant pharmaceutical manufacturing operations experience.
- 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:- Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
- Technical problem-solving skills.
- Good communications skills (both oral and written).
- Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
- Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
- Good organization skills.
- Ability to work with and learn new digital systems
- Ability to demonstrate attention to detail
Other Information: - During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 4 x 10 hour rotating shifts
- Ability to maintain focus on a complex task for 4-6 hours at a time.
- Adaptable to work in a fast-paced and evolving environment.
- Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties.
- Some overtime required.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $145,200
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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