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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.

Responsibilities

The Parenteral Technical Services - Primary Loop - Person in Plant role is the process expert for product and process steps in manufacturing relationships. As a member of the Joint Process Team (JPT), you will oversee day-to-day operations and the technical agenda for a parenteral drug product process.

Key Objectives/Deliverables:

• Support JPT Operations:

  • Become the process expert for steps and equipment within the process team.

  • Act as the primary contact for the JPT, supporting the leader in issue management.

  • Facilitate communication within the JPT.

  • Spend time on the floor to understand operations and monitor performance.

  • Observe the process while Lilly products are manufactured.

  • Understand the product/process, equipment, facilities, systems, and operations.

  • Define and own the process control strategy, including key parameters and quality attributes.

  • Understand product history and potential failure modes.

  • Educate JPT members on process requirements.

• Maintain Validated State:

  • Participate in design, execution, cleaning, sterility, and Bioburden control strategies.

  • Ensure accurate control strategy, process parameters, and quality attributes.

  • Assist in preparing process flow diagrams.

  • Monitor processes to ensure they remain validated.

  • Support annual product reviews and ongoing process verification.

  • Prepare for audits impacting Lilly products.

• Daily Operations Support:

  • Manage process-related deviations, complaints, corrective actions, and changes.

  • Lead root cause analysis and provide expert knowledge in incident investigations.

  • Ensure planned changes and deviations are managed appropriately.

  • Provide troubleshooting support.

  • Maintain awareness of issues and ensure resolution.

  • Assist with batch records and revisions.

• Process Improvement:

  • Evaluate process capability and yield variables.

  • Monitor processes using statistical tools to reduce variability and improve consistency.

Relationship with JPT:

• Ensure technical agenda is agreed upon and executed timely.

• Identify and conduct training for the External Manufacturer.

• Inform TS/MS (Technical Service/Manufacturing Science) Associate Director about project status and issues.

Department Initiatives:

• Communicate regularly with management and network leaders.

• Actively participate in JPT objectives.

• Provide input in monthly reports and metrics.

• Pursue continuous improvement opportunities.

• Model safety behaviors.

Relationships:

• Engage with contract manufacturers, Lilly TS/MS, QA, Auditing groups, and laboratories.

• Collaborate with senior TS/MS management, product and technical leaders, GPLOT leaders, and molecule/device stewards.

Basic Qualifications:

• Bachelor’s Degree in Pharmacy, Chemistry, Engineering, or related fields.

• Minimum of 5 years’ experience in pharmaceutical manufacturing parenteral or technical services.

Additional Skills/Preferences:

• Drug product experience preferred

• Experience with parenteral/aseptic manufacturing processes.

• Represent Eli Lilly’s mission positively and ethically.

• Thorough understanding of cGMPs and drug product manufacturing.

• Strong communication, technical curiosity, and critical thinking skills.

• High learning agility and leadership abilities.

• Effective teamwork across diverse teams.

• Use data and science to support decisions.

• Knowledge of statistical tools and regulatory experience.

• Equipment, utility, and facility qualification experience.

• Established technical, quality, and internal networks.

• Adaptable to change

Additional Information:

• Day shift, but off hours may be necessary.

• Travel up to 10%.

• Relocation assistance provided.

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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