Operations Associate - DAP RAMP Team
Apply NowCompany: Eli Lilly
Location: Indianapolis, IN 46227
Description:
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.
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 +35,000 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.
Lilly is starting up multiple new Device and Packaging (DAP) assets in manufacturing to increase our reach to patients. These assets will provide medicine for current and future products, and we need to improve the RAMP of these assets (Rapid Acceleration of Medicine to Patients). In order to start these lines with a strong safety, quality, and operationally excellent culture, TS/MS - DAP RAMP Team will be responsible for technical support of a cross functional team supporting all new startup DAP assets to support the sites during key milestones, supporting the training and upskilling of newly hired resources at the sites, and developing common processes and practices ultimately improving the RAMP curve for these assets ensuring safety first, quality always, while improving the operational efficiencies of these investments.
This is a unique opportunity to support global startup activities for greenfield manufacturing sites both internally and externally, and the successful candidate will help ensure overall site readiness plans to enable a successful startup into GMP manufacturing operations.
Key Objectives/Deliverables:
Operations Associate is responsible for providing provide technical oversight for reliable supply of commercial medicines and will work directly with sites to assure the successful and harmonized approach of new medicines introduction on device assembly and packaging lines, ensure standardized control strategies across the Device Assembly and Packaging (DAP) sites, and optimize capacity to maintain reliable supply for current and future products across the device/pack network. This role will partner with site TS/MS and/or MES teams and global TS/MS and/or MES areas to support technical resources who are responsible for supporting the sites through key milestones as additional technical capacity with the goal of improving the operational ramp curve for startup. This role will include 30-50% travel to the various startup sites in both the US and EU.
Basic Qualifications
Additional Preferences:
Additional Information
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
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.
#WeAreLilly
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 +35,000 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.
Lilly is starting up multiple new Device and Packaging (DAP) assets in manufacturing to increase our reach to patients. These assets will provide medicine for current and future products, and we need to improve the RAMP of these assets (Rapid Acceleration of Medicine to Patients). In order to start these lines with a strong safety, quality, and operationally excellent culture, TS/MS - DAP RAMP Team will be responsible for technical support of a cross functional team supporting all new startup DAP assets to support the sites during key milestones, supporting the training and upskilling of newly hired resources at the sites, and developing common processes and practices ultimately improving the RAMP curve for these assets ensuring safety first, quality always, while improving the operational efficiencies of these investments.
This is a unique opportunity to support global startup activities for greenfield manufacturing sites both internally and externally, and the successful candidate will help ensure overall site readiness plans to enable a successful startup into GMP manufacturing operations.
Key Objectives/Deliverables:
Operations Associate is responsible for providing provide technical oversight for reliable supply of commercial medicines and will work directly with sites to assure the successful and harmonized approach of new medicines introduction on device assembly and packaging lines, ensure standardized control strategies across the Device Assembly and Packaging (DAP) sites, and optimize capacity to maintain reliable supply for current and future products across the device/pack network. This role will partner with site TS/MS and/or MES teams and global TS/MS and/or MES areas to support technical resources who are responsible for supporting the sites through key milestones as additional technical capacity with the goal of improving the operational ramp curve for startup. This role will include 30-50% travel to the various startup sites in both the US and EU.
- Develop and implement harmonized approaches, strategies and standards across the network of packaging / device sites in areas such as performance qualification, process validation, ongoing process verification/process monitoring, stability requirements and qualification of shipping/material movements.
- Coach site resources on resolution and escalation of issues related to materials and validated process.
- Work with site personnel to drive continuous improvement of the electronic batch record to reduce human error, streamline operations, and improve data quality.
- Work with packaging / device TSMS and/or site personnel and global functions to assure platform approach, ensure replication, harmonized approaches with the identification of best practices and continuous shared learnings.
- Knowledge sharing - Serve as a key resource to support site device assembly and/or packaging engineering groups, domestic and global.
- Prepares presentations and technical reports.
- Develop common tools and practices for site start-up activities to support future start-ups' acceleration to operational readiness.
Basic Qualifications
- Bachelor's degree in a science related field
- 5+ years Engineering, Technical services, or QA experience in plant, process, or related fields supporting device assembly and/or packaging operations
Additional Preferences:
- Experience with control strategy of device assembly and/or packaging equipment, specifications, qualification/validation process, product/package stability, and packaging components
- Establish key relationships with Sites.
- Problem Solving skills - Anticipates and resolves complex problems.
- Ability to work independently and with minimal direction
- Ability to work across boundaries (functional, geographic, external company, etc).
- Experience with operation and continuous improvement of manufacturing execution systems (MES)
- Thorough technical understanding of the quality systems and regulatory requirements
- Familiarity with technology advances in device assembly and packaging
Additional Information
- Must be able to travel up to 30-50% of the time, US and international.
- Will require occasional work in a variety of manufacturing environments; some safety equipment and/or gowning may be required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
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.
#WeAreLilly