Scientist/Engineer – Biologics Technical Operations – Lilly Medicine Foundry Full-time

Lilly Medicine Foundry Manufacturing Scientist/Engineer – Technical Operations

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Lilly Medicine Foundry Manufacturing Scientist/Engineer – Technical Operations supports and potentially executes on shift operations activities to ensure effective and consistent execution on the operation floor. This role provides on floor operation execution working directly with operators, supports batch readiness and release, and works cross-functionally to provide technical and operational oversight to routine operations. The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) in introducing new processes into the plant. The Scientist/Engineer – Technical Operations represents operations leading detailed planning of process changeover, and the new product introduction process.

In the pre-startup phase, the Scientist/Engineer – Technical Operations will contribute heavily to Operational Readiness activities for the new facility supporting technical processes, tech transfer, operational readiness, delivery of trainings, procedures, and workflows. Initially, the Scientist/Engineer – Technical Operations will be responsible for supporting equipment qualification and site acceptance tests (SAT) while developing standard operating procedures and operator training plans.

Upon completion of the project phase, the Scientist/Engineer – Technical Operations will provide technical oversight and ownership for the operations team providing on the floor training and process support, and leading incident investigations. This role plays a key technical role working collaboratively with the Process Translation and Execution (PTE), Processing Engineering (PE) and Product Research and Development (PRD) to prepare for effective delivery of our products. This role provides key technical input and participates in pre-startup activities such as Process Hazard Reviews (PHRs), development batch instructions, and support on the floor operations. The Scientist/Engineer could participate in performing routine manufacturing activities and may be on shift as needed in future operations. The Scientist/Engineer – Technical Operations ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

This role may require domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Key Responsibilities:

• Provide on the floor shift support for the operations staff for technical, training, and process support and at times execute production activities.
• Leverage problem solving skills to evaluate process & protocols, deviations real-time and provide assessments to cross functional process teams.
• Apply independent judgement and discretion to execute equipment commissioning and qualification testing under the guidance of the C&Q
• Conduct and appropriately document production via adherence to digital manufacturing batch records and affiliated SOPs.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
• Ensure improvement opportunities from Operators are appropriately documented and assessed
• Work with area maintenance to schedule work orders for corrective maintenance.
• Lead Safety and Quality Investigations and author investigation reports.
• Cross-functional collaboration to enable Foundry technology transfers.
• Serve as a key resource for operational improvement projects and other initiatives.
• Partner with functional groups to prepare for process campaigns creating project plans for changeover execution, including optimized approaches for cleandown, piping, maintenance, and equipment setup execution. Coordinate and oversee project execution to meet desired timelines.
• Work cross-functionally with PE, PTE, PRD, HSE, and Quality Assurance to ensure processes are transferred and executed successfully in the Foundry.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards and represent operations in Process Hazard Review (PHR) meetings and other HSE-related venues.
• Promote continuous improvement of area changeover workflows to make changeovers easier or more efficient.
• Collaborate in a fast paced team environment

Basic Requirements:

• Bachelor's Degree in science, engineering, or technical field
• or
• Associate's Degree or HS Diploma/GED with 5+ years of directly applicable manufacturing experience pharmaceutical operations (Small Molecule, Biologics, or Mixed Modalities) including on the operations, incident investigations (safety and quality), authoring procedures/instructions, and process hazard reviews.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Preferences:

• Experience in clinical biologics operations and technology transfer
• Experience in Pharmaceutical Product Research and Development
• Experience providing technical and/or coordination support toward cleaning, changeover, and/or maintenance activities in a GMP production environment
• Formal project management training considered a plus
• Demonstrated leadership and influencing experience
• Previous experience in facility or area start-up environments.
• A solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
• Ability to effectively communicate (electronically, written and verbal).

Other Information:

• Initial location at Lilly Technology Center, Indianapolis, or Parkwood West, Carmel, Indiana
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
• Travel Percentage: 5%
• Position requires on-site presence on a M-F schedule, with flexibility to support operations activities in a 24/7 hour manufacturing environment during nights and weekends as needed.

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 for further assistance.

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 $66,000 – $171,600.

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.