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

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. Key Objectives /

Deliverables:

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.

Basic 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)

Additional Information:

Role is Monday through Friday based but must be flexible in providing support to accommodate business needs (e.g. production schedules, special technical studies, shutdowns). Occasional extended hour and/or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required. Periodic on-call support for production will be required. The role requires frequent presence on production floor (CNC/Grade C) and primary office location may be in a CNC area. The successful candidate is expected to be assigned to the filling process but may also support other process areas (e.g. formulation, visual inspection) 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 (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 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. #WeAreLilly