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Lilly Material and Component Scientist – 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.

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.

The Material & Component Scientist – Technical Services / Manufacturing Science (TS/MS) role encompasses technical leadership with regard to high risk materials, including primary/critical secondary packaging components (e.g. glass containers, elastomeric closures, seals), raw materials, and GMP consumables used at the Lilly RTP site. This role responsible and accountable for ensuring the materials used in the manufacturing processes are in control and capable in a continuous improvement mode.

Primary responsibilities of the position include understanding and ownership of the control strategy as it relates to materials and components. The Material and Component Scientist is responsible for providing technical support in order to achieve the reliable and compliant manufacture of parenteral drug product. 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 expert in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes, up through and including regulatory submission.

Key Objectives / Deliverables:

  • Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, product contact materials, and container closure systems.

  • Act as a site subject matter expert and provide deep scientific and technical expertise for high risk materials (including primary/critical secondary packaging components), raw materials, and GMP consumables used in the drug product manufacturing process.

  • Understand, justify, and document the state of qualification of components with data that evaluate the capability of the manufacturing process to meet its stated purpose.

  • Establish and maintain technical documents and specifications for materials and components.

  • Establish critical attributes for high-risk materials and execute studies as needed to define the limits of these parameters.

  • Create, maintain, and perform applicable periodic review of materials and consumables.

  • Evaluate the impact of changes at suppliers to the product/process.

  • Lead/support technical projects to improve process control, capacity, quality, yield, and attribute measurement as related to materials and components.

  • Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.

  • Develop and implement a technical agenda with regard to materials used in the manufacture of parenteral products.

  • Participate in troubleshooting and driving continuous improvement as it relates to materials and components.

  • 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 container closure integrity.

  • 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.

  • Provide manufacturing input on regulatory submissions and other pertinent regulatory topics related to product contact materials and container closure.

  • Support risk management activities as it pertains to materials and components.

  • Serve as technical interface external to the RTP site.

  • Provide audit support, as needed.

  • Collaborate with and influence partners across the Parenteral Network.

  • Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

Basic Requirements:

  • BS or MS in Material Science/Engineering, Biochemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

  • Experience with data trending and analysis

Additional Preferences:

  • Ability to analyze complex data and solve problems

  • 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

  • Knowledge of parenteral drug product manufacturing

  • Experience supporting cGMP manufacturing (specifically within process development, technical services/MSAT, quality assurance, quality control etc.)

  • Knowledge of container closure systems

  • Understands compendial and international standards requirements

  • Demonstrated successful leadership of cross-functional teams

Additional 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 ( LillyRecruitingCompliance@lists.lilly.com ) 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).

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