Lilly Device Assembly Scientist/Engineer – Technical Services/Manufacturing Science (TS/MS) in Research Triangle Park, North Carolina
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 35,000 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.
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.
The Scientist – Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and implements a technical agenda and is responsible for providing technical leadership for commercial TS/MS activities within Lilly-RTP site. This role will initially focus on the delivery of the Device Assembly and Packaging operations but will also engage in the design of the prefilled syringe operations.
Primary objectives include the start-up and compliant manufacturing of RTP products, including implementation of the process control and validation strategy. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the RTP site.
While this role is not expected to be the technical expert on all products and platforms, it is expected to be the expert in regulatory, internal, and other requirements. 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, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Provide technical support for all start-up activities (e.g., tech transfer, process validation)
Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
Support and/or own the technical agenda for the product or validation process.
Lead risk management activities as it pertains to products.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
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.
Drive the stability strategy for RTP products.
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.
BS or MS in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Biochemistry, or other related scientific discipline
Experience supporting cGMP manufacturing operations (specifically within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.)
Ability to learn new processes and computer system applications
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
Experience in TS/MS, MSAT, Operations, or Quality Assurance, particularly in the areas of device assembly and packaging
Previous experience with deviation and change management systems, including Trackwise
Demonstrated successful leadership of cross-functional teams
Knowledge of CMC aspects of drug product manufacturing
Role is Monday through Friday based. 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
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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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).