Scientist – CT Parenteral Ops

Industry:

Company: Eli Lilly and Company

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.

The Clinical Trial (CT) manufacturing organization will be responsible for the make and release of parenteral drug product, supporting the Clinical Supply and Delivery (CSD) organization and their objectives. The facility is a manufacturing plant specializing in aseptic processing and sterile medicines production for clinical trials, along with the associated technical data and documentation to support GMP activities. The plant is located within Building 358 (B358) in Indianapolis, IN at the Lilly Technology Center North campus.

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 selected candidate will also represent, and be the primary owner, of new product technology transfers to B358 CT operations while supporting day-to-day manufacturing operations.
Responsibilities:

• 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.
• Apply organizational change system to build, approve, implement, 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 implement nonroutine technical studies to support manufacturing.
• Ownership of Process Risk Assessments
• Retain 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.
• Participate in new equipment PQ/startup activities through Reviews, Approvals, Execution and/or consultation on activities as needed.

Basic Qualifications:

• 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.
• Apply organizational change system to build, approve, implement, 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 implement nonroutine technical studies to support manufacturing.
• Responsible for maintaining the B358 approved GMP consumables list and performing activities for adding new consumables.
• Be involved in new equipment PQ/startup activities through Reviews, Approvals, Execution and/or consultation on activities as needed.

Additional Skills and Preferences:

• Experience with freeze-dry operations.
• Familiarity with Trackwise1000 and SAP
• BS in Pharmaceutical Sciences, Chemical/Bichemical Engineering, or related field.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly