Manufacturing Operations Associate - Lebanon Advanced Therapies

Eli Lilly and Company; Lebanon (IN); On-site; USD 66,000 - 145,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Job summary

Lilly is seeking a Manufacturing Operations Associate for the LP-2 gene therapy facility in Lebanon, Indiana. This leadership development role focuses on startup, process design, planning, and seamless GMP start-up of production areas.

Responsibilities include training, safety culture, deviation investigations, continuous improvement, and collaboration with Engineering, Tech Services, Quality & Regulatory to deliver the Operational Excellence Roadmap.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years of operational/engineering/technical services or pharmaceutical manufacturing experience.
• Authorized to work in the United States on a full-time basis; Lilly does not provide visa sponsorship.

Responsibilities

• Assist Process Team Leaders to drive safety, quality, and manufacturing performance.
• Ensure cGMP readiness for start-up and process qualification activities.
• Support validation activities and maintain GMP production areas in compliance.
• Foster a safety-first culture with accountability and safe systems of work.
• Provide continuity in process activities and escalate issues when needed.
• Lead or participate in continuous improvement projects and cost reduction programs.
• Support and drive the Operational Excellence Roadmap for LP2 Flow Team.
• Lead manufacturing projects with cross-functional stakeholders.
• Help author and revise SOPs and batch records; review technical reports.

Skills

5+ years experience

Education

Bachelor's degree in engineering or related technical field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

The Manufacturing Operations Associate for the Lilly Advanced Therapies Manufacturing Facility, LP-2, Lebanon, Indiana, will be a leadership development role, responsible for successful delivery of production areas and gene therapy facility startup. These responsibilities include: process design, planning, and seamless start-up of GMP production.

The successful candidate will be required to build deep operating expertise in their area of responsibility (including in-depth knowledge of the site operating systems and processes), have a strong working knowledge of the laboratory and manufacturing equipment set, control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the processing suites are in-control, compliant, and maintained in a validated state through continual monitoring. The OA may play a role in implementing new technologies and operational process improvements in the GMP manufacturing environment. The Manufacturing Operations Associate is expected to partner with Engineering, Tech Services, Quality & Regulatory to troubleshoot processes and deliver on a continuous improvement agenda.

Your Responsibilities Will Include

• 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; elevate 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.

Minimum Requirements

• Bachelor's degree in engineering or related technical field.
• 5+ years of Operational, Engineering, Technical Services, or Pharmaceutical Manufacturing Experience.
• Qualified applicants must be 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.

Additional Preferences

• Demonstrated operational capability with high productivity.
• Proven track record of curiosity with learning agility.
• Demonstrated excellent problem-solving skills.
• Self-starter with high initiative and data-driven approach to problem-solving.
• Demonstrated ability to participate in and facilitate technical decision-making.
• Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated strong verbal and written communication skills.
• Strong interest in leadership including cross-functional operations leadership.
• An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification.
• An understanding of normal process variability (expected) and special cause variability.

Other Information

• 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 (

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $145,200

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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