Material Scientist, Container Closure Systems​/Primary Packaging Components

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Technical Services/Manufacturing Sciences (TS/MS) function provides technical expertise in key areas of product commercialization, technology transfer and manufacturing process oversight. TS/MS technical expertise is utilized to ensure Lilly products are manufactured with the highest level of quality and excellence possible. You will provide Material Science technical support for Container Closure Systems (CCS) and their Primary Packaging Components (PPC) used by Parenteral manufacturing processes in the Parenteral and Device Network (PDN)

** Key Objectives/Deliverables*
* + Technical assessment of PPC to support supplier changes or additions and evaluate their impact on the CCS.

+ Integrate parenteral processing requirements into the design, selection, and qualification of container/closure components.

+ Expert contribution in complex CCS process investigations or complaints

+ Perform process capability assessments and root cause analyses.

+ Represent Lilly TS/MS in interactions and partnerships with packaging material suppliers, supporting continuous improvement activities.

+ Write component and system qualification plans and reports.

+ Develop specifications and control strategies.

+ Provide TS/MS CCS support for regulatory inspections and/or supplier technical audits

+ Maintain a deep understanding of suppliers' processes, control strategies, capabilities, and failure modes.

+ Have a basic understanding of Lilly drug product formulation and analytical challenges.

+ Write and review regulatory submission modules and dossiers specific to components and systems.

+ Write and review Lilly global standards and strategies with CCS/PPC in scope.

+ Foster strong partnerships across platforms, including Lilly development, Lilly sites, CMOs, and suppliers.

+ Explore and apply engineering methods for modeling and designing new container/closure systems.

+ Be responsible for designing experiments and interpreting data.

+ Keep track of and apply current regulatory guidance and industry practices in primary packaging materials and container closure systems.

** Basic Requirements:*
* + Engage with parenteral drug product manufacturing sites. Support sites for technical issues.

+ Engage with packaging material suppliers in activities related to material manufacturing changes and continuous improvement.

+ Engage with Development and drug product CMC teams for new container development as the voice of manufacturing.

+ Strong problem-solving and communication skills (ie: black belt background)

+ Understand regulatory requirements

+ Identify and develop new technologies applicable to Lilly parenteral container closure systems (cartridges, syringes, vials and flexible container)

+ Fluent in written and spoken English

+ Availability to travel for about 15% of your time

** Additional Preferences:*
* + Ability to work well independently and remotely, as well as in global and multicultural teams.

+ Project management skills

+ Flexibility to interact with multiple partners including vendors/CMO organizations, regions and cultures

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* Education Requirements:

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* + Bachelor's degree in chemistry, Mechanical Engineering, Biomedical Engineering, Packaging Engineering, Materials Sciences, or related science fields.

+ Masters (or equivalent work experience) preferred.

+ 3+ years of experience in Good Manufacturing Practice regulated environment.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change…