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.
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 Device Assembly Senior/Principal 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 operations but may also engage in support of packaging 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 and packaging 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.
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
Knowledge of CMC aspects of drug product manufacturing
Experience supporting cGMP manufacturing operations
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, particularly in the areas of device assembly and packaging
Technical Transfer experience, including equipment qualification and process validation
Demonstrated successful leadership of cross-functional teams
Previous experience with deviation and change management systems, including Trackwise
5-7 years of experience preferred.
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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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).