Eli Lilly and Company
Overview
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 39,000 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.
TS/MS Materials – Scientist
Company Overview
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 39,000 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. #WeAreLilly
Responsibilities
Primary responsibilities include understanding and owning the control strategy as it relates to materials and components. The Materials and Component Scientist provides technical support to achieve reliable and compliant manufacture of parenteral drug product.
Scope includes syringe filling, device assembly, and packaging operations for commercially manufactured products targeted for transfer to the
Kenosha, Wisconsin
site.
Act as the expert in regulatory, internal, and other requirements, with a focus on ensuring consistency in approach and processes up to regulatory submission.
Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including interactions among chemistry, equipment, product contact materials, and container closure systems.
Provide deep scientific and technical expertise for high risk materials, raw materials, and GMP consumables used in the drug product manufacturing process as a site subject matter expert.
Understand, justify, and document the state of qualification of components with data evaluating 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 to define the limits of these parameters.
Create, maintain, and perform periodic review of materials and consumables.
Evaluate the impact of changes at suppliers to the product/process.
Lead or support technical projects to improve process control, capacity, quality, yield, and attribute measurement related to materials and components.
Develop, monitor, and respond to 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 drive continuous improvement related to materials and components.
Provide technical support for start-up activities (e.g., tech transfer, process validation).
Provide technical support for non-routine investigations (deviations, complaints) including consultation on quality and container closure integrity.
Prepare, review, approve, and provide technical support for relevant technical documents 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 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
Kenosha, Wisconsin
site.
Provide audit support as needed.
Collaborate with partners across the Parenteral Network.
Ensure a safe working environment through compliance with safety rules and by actively participating in safety-related activities.
Basic Qualifications
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 Skills/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 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. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and/or off-hour work may be required.
This job description 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 over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. Consult with your supervisor regarding actual job responsibilities and related duties.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
#J-18808-Ljbffr
TS/MS Materials – Scientist
Company Overview
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 39,000 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. #WeAreLilly
Responsibilities
Primary responsibilities include understanding and owning the control strategy as it relates to materials and components. The Materials and Component Scientist provides technical support to achieve reliable and compliant manufacture of parenteral drug product.
Scope includes syringe filling, device assembly, and packaging operations for commercially manufactured products targeted for transfer to the
Kenosha, Wisconsin
site.
Act as the expert in regulatory, internal, and other requirements, with a focus on ensuring consistency in approach and processes up to regulatory submission.
Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including interactions among chemistry, equipment, product contact materials, and container closure systems.
Provide deep scientific and technical expertise for high risk materials, raw materials, and GMP consumables used in the drug product manufacturing process as a site subject matter expert.
Understand, justify, and document the state of qualification of components with data evaluating 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 to define the limits of these parameters.
Create, maintain, and perform periodic review of materials and consumables.
Evaluate the impact of changes at suppliers to the product/process.
Lead or support technical projects to improve process control, capacity, quality, yield, and attribute measurement related to materials and components.
Develop, monitor, and respond to 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 drive continuous improvement related to materials and components.
Provide technical support for start-up activities (e.g., tech transfer, process validation).
Provide technical support for non-routine investigations (deviations, complaints) including consultation on quality and container closure integrity.
Prepare, review, approve, and provide technical support for relevant technical documents 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 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
Kenosha, Wisconsin
site.
Provide audit support as needed.
Collaborate with partners across the Parenteral Network.
Ensure a safe working environment through compliance with safety rules and by actively participating in safety-related activities.
Basic Qualifications
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 Skills/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 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. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and/or off-hour work may be required.
This job description 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 over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. Consult with your supervisor regarding actual job responsibilities and related duties.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
#J-18808-Ljbffr