Scientist/Engineer, Technical Operations - Lilly Medicine Foundry

Lilly • Indianapolis, IN

11d • $66,000 - $171,600 • Onsite

About The Position

Lilly is investing $4.5 billion to create the Lilly Medicine Foundry, a new center for advanced drug development and manufacturing. This facility, the first of its kind, combines research and manufacturing to optimize processes, increase capacity for clinical trial medicines, reduce costs, and minimize environmental impact. The Manufacturing Scientist/Engineer – Technical Operations role supports and executes on-shift operations activities to ensure effective and consistent execution on the manufacturing floor. This role involves direct work with operators, supporting batch readiness and release, and cross-functional collaboration for technical and operational oversight of routine operations. The Scientist/Engineer will become an expert in their assigned area (Small Molecule, Hybrid, or Biologics) and act as a key integrator with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) for introducing new processes. They will represent operations in the detailed planning of process changeover and new product introduction. During the pre-startup phase, this role will contribute significantly to Operational Readiness activities, including supporting technical processes, tech transfer, training delivery, and developing procedures and workflows. Initially, responsibilities include supporting equipment qualification and site acceptance tests (SAT), developing standard operating procedures, and creating operator training plans. Post-project completion, the role shifts to providing technical oversight and ownership for the operations team, including on-floor training, process support, and leading incident investigations. This position plays a key technical role in preparing for effective product delivery by collaborating with PTE, PE, and PRD. It provides critical technical input and participates in pre-startup activities such as Process Hazard Reviews (PHRs), developing batch instructions, and supporting floor operations. The Scientist/Engineer may also perform routine manufacturing activities and could be on shift as needed. A safety-first, quality-always approach is essential, managing production processes with diverse unit operations and manufacturing skills. This role may require domestic and international travel for collaboration, training, and learning from API production sites.

Requirements

• Bachelor’s or Associate's Degree in science, engineering; OR technical field 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 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.

Nice To Haves

• Experience in Pharmaceutical Product Research and Development a plus
• 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).

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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree