Scientist/Engineer - Technical Services/Manufacturing Science (Filling)

Lilly

2d • Onsite

About The Position

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.
The Scientist/Engineer – Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for parenteral operations and projects for filling. This role will span the design and delivery of prefilled syringe operations as well as support of routine manufacturing operations. The role will interact with peers within the parenteral network and in Global TS/MS to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.

Requirements

• BS or MS in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Biochemistry, or other related scientific discipline
• Minimum 5 years of experience supporting cGMP manufacturing (e.g. within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance)

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Perform root cause analysis and apply scientific principles and understanding in response to manufacturing deviations.
• Provide technical support for start-up activities in particular technology transfer and process validation.
• Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, procedures, master batch records, protocols and summary reports, technical studies, and regulatory submissions.
• Provide technical support for non-routine investigations (e.g. deviations and complaints).
• Ensure that an accurate instruction set (manufacturing batch records & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Serve as technical interface external to the RTP site.
• Provide audit support.
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level