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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 serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Organization Overview:

This position is responsible for second shift technical support of manufacturing operations. This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of Lilly products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Support hours are Four days on – Four days off from approximately 12:00 pm to 12:30 am

Responsibilities:

Responsible for supporting manufacturing operations through the performance of the following duties and representing TS/MS on Manufacturing Process Teams:

1. Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Drives solutions for products and processes.

2. Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves problems. Communicates issues in a timely manner. Assists during process-related investigations and assesses technical impact. Serves as a key resource within a TS/MS area or discipline. Gains support for ideas or positions on difficult issues.

3. Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issues.

4. Authors technical reports supporting process control strategies, technology transfers, deviation observations, process monitoring/analyses, and technical studies.

5. Writes standard operating procedures as they relate to the activities of the TS/MS group. Authors or revises Manufacturing procedures and batch records as necessary to enable precise execution and ensure practice matches procedure. Reviews and approves manufacturing batch records and other manufacturing documentation.

6. Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.

7. As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements and change controls to manufacturing processes.

8. Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to implement control strategies for Lilly Branchburg processes.

9. As required, may lead or assist in the planning and execution of process validation activities.

10. Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.

Basic Requirements:

BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline.

Position is a banded position and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered in initial placement within the band.

Excellent communication skills, both oral and written.

Additional Skills/Preferences:

Experience in fermentation/cell culture and/or protein purification manufacturing.

Process and equipment knowledge of cell culture or purification functions.

Thorough understanding of GMP requirements for a large scale manufacturing facility.

Demonstrated leadership skills.

Additional Information:

Travel: <10%

Shift: Support hours are approximately:

2PM -10PM Wednesday

2PM -12AM Thursday

2PM -12AM Friday

12PM -12AM Saturday

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

$72,000 - $189,200

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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