Manufacturing Operations Associate - Lebanon Advanced Therapies

Role Summary

Manufacturing Operations Associate, Lebanon Advanced Therapies (LP-2) – Lebanon, Indiana. This leadership development role supports startup and successful delivery of production areas and the gene therapy facility startup, focusing on process design, planning, and seamless start-up of GMP production. The role requires building deep operating expertise in the area of responsibility, a strong working knowledge of laboratory and manufacturing equipment, control systems, and data-driven decision‑making and problem-solving capabilities. The OA will partner with Engineering, Tech Services, Quality & Regulatory to troubleshoot processes and drive continuous improvement.

Responsibilities

• Assisting the Process Team Leaders with leading the Process Teams, specifically focusing on safety, quality, and manufacturing performance using appropriate performance metrics and targets.
• Ensure cGMP readiness of manufacturing areas for start-up and process qualification activities. Participate in and support training and engineering runs.
• Responsible for supporting validation activities and ensuring GMP production areas are within compliance.
• Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
• When required (and per delegation procedure), in the absence of the Associate Director-Manufacturing provide continuity to the Process Team activities and operational aspects of the process; escalate issues to the Senior Director of Manufacturing Operations as needed.
• Lead or participate in continuous improvement projects through capacity optimization and cost reduction programs.
• Support the development and drive the Operational Excellence Roadmap for LP2 Flow Team.
• Lead Manufacturing Projects with the support of cross-functional stakeholders.
• Support authoring and revision of standard operating procedures and batch records as required. Review technical reports. Conduct deviation investigations and write process deviation reports.
• Document and appropriately communicate all aspects of work and learnings.
• Provide training and mentorship for new personnel.

Qualifications

• Required: Bachelor’s degree in engineering or related technical field.
• Required: 5+ years of Operational, Engineering or Technical Services Experience.
• Required: Authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Preferred: Demonstrated operational capability with high productivity.
• Preferred: Proven track record of curiosity with learning agility.
• Preferred: Demonstrated excellent problem-solving skills.
• Preferred: Self-starter with high initiative and data-driven approach to problem-solving.
• Preferred: Demonstrated ability to participate in and facilitate technical decision-making.
• Preferred: Demonstrated strong interpersonal skills with adaptability and flexibility to working in different environments, teams, etc.
• Preferred: Demonstrated strong verbal and written communication skills.
• Preferred: Strong interest in leadership including cross-functional operations leadership.
• Preferred: An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification.
• Preferred: An understanding of normal process variability (expected) and special cause variability.

Additional Requirements

• Normal workday: 8 hour days – Monday through Friday.
• Must be flexible to attend meetings or support off-shifts as necessary.
• Some US and OUS travel may be required.