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Lilly MES Scientist – Technical Services/Manufacturing Science 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.

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 MES Scientist – Technical Services / Manufacturing Science (TS/MS) role is responsible for providing technical support for the development, implementation, and execution of a manufacturing execution system (electronic batch record) to achieve reliable, sustainable, and compliant manufacturing of drug products at the Lilly RTP site. This role will initially focus on the design and delivery of the MES production instructions (referred to as tickets), and then transition to support of routine manufacturing operations, including identifying and implementing required MES upgrades and ticket changes.

Primary objectives include but are not limited to, partnering with IT MES resources for ticket design, development, and updates for commercial products, ensuring all MES deliverables and landmarks are met, and resolving any MES related issues so that the product control strategy can be effectively and reliably executed. The scope of the role includes syringe filling, device assembly, and packaging 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 knowledgeable 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, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.

  • Partner with IT, Quality, Production, and Engineering (site based and globally) to develop reliable, sustainable, and compliant manufacturing PMX tickets.

  • Serve as PMX TS/MS subject matter expert (SME) and provide technical leadership to the PMX team, specific to process and ticket rewuirements for parenteral drug product manufacturing.

  • Translate product control strategy and process flow document (PFD) requirements into accurate instruction sets (e.g. PMX tickets, electronic batch records, electronic procedures).

  • Partner with IT PMX and other TS/MS scientist resources for ticket design and development inputs, including how PMX interfaces with other automation systems, LIMS systems, etc.

  • Lead/support development of new PMX tickets; maintain accuracy of PMX tickets and ensure that they can be executed as written.

  • Participate in design reviews, final design specification review, and localization of PMX tickets.

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

  • Identify changes required for PMX, solicit input from stakeholders, and ensure changes are implemented consistently with operational practices.

  • Lead the change prioritization process, working with the business to understand change requirements and collaborating with IT to understand complexity

  • Power user for PMX upgrades in order to write/approve test scripts accordingly.

  • Lead training and troubleshooting for Operations.

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

  • Prepare, review, approve, and provide technical support for preparation of relevant technical documents specific to PMX, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.

  • 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.

Minimum Requirements:

  • BS or MS in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, Biochemical Engineering, or other related scientific discipline

  • Experience supporting cGMP manufacturing (specifically within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.)

Additional Preferences:

  • Knowledge and understanding of parenteral drug product manufacturing, including equipment, facilities, computer systems and operations

  • Ability to learn new processes and computer system applications

  • Strong computer skills

  • 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, or Operations, Quality Assurance

  • Understanding of operational control strategy (e.g., CQA, CPP, CIPC, et.c)

  • Proven understanding of PMX or other manufacturing execution systems (MES)

  • Technical knowledge of how to build and test in PMX

  • Ability to analyze complex data and solve problems

  • Demonstrated successful leadership of cross-functional teams

  • Project management experience

Education Requirements:

BS or MS in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, Biochemical Engineering, or other related scientific discipline

Other Information:

  • 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

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).