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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

This position is within the Operations (OPS) team of the manufacturing organization. The Scientist will provide technical oversight and ownership for assigned processes which could include, dispensing and formulation, filling, freeze drying, inspection and/or final packing into shippable containers.  The Scientist will also represent, and be the primary owner, of new product technology transfers to B358 CT operations while supporting day-to-day manufacturing operations. 

The scientist will effectively collaborate with both internal and external partners to achieve desired results. 

Key Objectives/Deliverables:  

Knowledgeable on how to apply GMPs in a clinical trial environment 

Capability to write, train, review, and follow procedures applicable to the CT business 

Responsible for issuance of pre-executed B358 CT manufacturing batch records and performing post-execution technical review 

Utilize change management system to create, approve, execute, close changes and associated action items relevant the CT manufacturing process 

Ownership of ancillary support processes (Filter Integrity Testing, etc) 

Author and review GMP manufacturing related investigations and complaint investigations 

Author, review, and execute nonroutine technical studies to support manufacturing 

Ownership of Process Risk Assessments 

Maintain ownership and emphasis on quality, ensuring quality in all daily activities 

Responsible for maintaining the B358 approved GMP consumables list and performing activities for adding new consumables 

Responsible for performing SME review of vendor changes 

Support process engineers with manufacturing technical oversight 

Participate in new equipment PQ/startup activities through Reviews, Approvals, Execution and/or consultation on activities as needed 

Basic Requirements: 

5+ years experience in Formulation Development, CT or Commercial manufacturing. 

Exceptional organizational skills with attention to detail 

Strong problem-solving skills with the ability to identify key issues in manufacturing process and lead a team to the appropriate solution(s) for complex problems 

Excellent verbal and written communications skills with the ability to interact well in a team environment and across multiple levels of an organization 

Must be able to work in an environment with a lot of autonomy 

Additional Preferences: 

Experience with freeze-dry operations. 

Experience with single-use formulation bags and filling assemblies. 

Familiarity with Trackwise1000 and SAP. 

Education Requirements: 

BS in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering or related field. 

Additional Information/Requirements: 

Monday through Friday Day Shift 

Some work outside of core hours may be required to enable the delivery of the portfolio 

Some domestic and/or international travel 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

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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