Scientist - TS/MS Visual Inspection

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

Responsibilities:

The Visual Inspection Scientist/Engineer – Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes. The role is responsible for teaching, mentoring, and coaching peronnel in all aspects relating to visual inspection processes within the Lilly RTP site. This role will span the design and delivery of prefilled syringe visual inspection operations as well as support of routine manufacturing operations.

The Visual Inspection Scientist/Engineer will be responsible for the training and qualification program associated with visual inspection, classification of defects and maintenance of defect kits, and maintaining the visual inspection strategy for parenteral operations. This role will also participate in troubleshooting and driving continuous improvement as it relates to the visual inspection program. The role will regularly 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.

A key part of this role is ensuring that there is consistency in approach / processes throughout the product lifecycle, from tech transfer to regulatory submission and beyond to routine manufacturing.

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.

• Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.

• Perform root cause analysis and apply scientific principles and understanding in response to manufacturing deviations.

• Provide technical support for all start-up activities (e.g., tech transfer, process validation), including support of equipment qualification and validation.

• Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, protocols and summary reports, defect classifications, technical studies, and regulatory submissions.

• Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality.

• Ensure that an accurate instruction set (tickets & 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, as needed.

• Work within or lead cross-functional teams in a positive fashion 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 (specifically within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.)

Additional Preferences:

• Strong interpersonal and teamwork skills

• Strong self-management and organizational skills

• Oral and written communication skills that demonstrate an ability to effectively communicate with all levels of the organization

• Experience in TS/MS, MSAT, Quality, Engineering, or Operations, particularly with visual inspection of parenteral drug products

• Experience with qualification or/and support of automated and semi-automated visual inspection equipment for parenteral operations

• Technical Transfer experience, including equipment qualification and process validation

• Experience with data trending and analysis

• Ability to analyze complex data and solve problems

• Demonstrated successful leadership of cross-functional teams

• Previous experience with deviation and change management systems, including Trackwise

Additional Information:

• Role is Monday through Friday based but must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). 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

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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