Materials Scientist - Single Use Systems

Job Description

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.

Position Brand Description:

Scientist in global Technical Service/Manufacturing Science (TS/MS) serving as a subject matter expert (SME) for Product Contact Material, Single use or Reusable Systems used in formulation and filling of parenteral products.

Key Objectives/Deliverables

• Scientist accountable for the technical evaluation of single use or reusable components and systems in support of supplier change and/or new component/system qualifications.

• Integrate parenteral processing requirements into design, screening, selection and qualification of PCM.

• Write component and system qualification plan and reports

• Develop specifications and control strategies

• Responsible for design of experiments and interpretation of the data

• Perform process capability assessments and root cause analysis

• Bring technical expertise and oversight by supporting supplier audits

• Have an understanding of supplier’s formulations, processes, controls strategies, capabilities and failure modes.

• Have the basic understanding of Lilly drug product formulation and analytical challenges in order to correlate the use of PCM materials to the manufacturing processes

• Write and review regulatory submission modules/dossiers specific to PCM

• Create and provide ownership to global portfolio of single use systems for the parenteral network

• Develop strong Partnership across Lilly sites, CMOs, Development, other Global functions, and suppliers

• Maintain and apply contemporary regulatory guidance and industry practices in PCM technical areas

• Provide support to change agenda and commercialization agenda to ensure robust supply can be met

Basic Requirements:

•2-4 years of experience in parenteral pharmaceutical process development / manufacturing or equivalent educational experience (i.e. Master's degree or PhD)

• Engage with PCM suppliers in activities related to material manufacturing changes and continuous improvement.

• Engage with parenteral drug product manufacturing sites and provide support sites as technical challenges arise.

• Engage with Development, Engineering and drug product CMC teams for new PCM as the voice of manufacturing.

• Good problem solving and communication skills

• Understand regulatory requirements

• Understand compendia and international standards requirements

• Understand regulatory HSE requirements

• Ability to work well independently and in teams

• This role will work extensively with the PCM Steward

• Identify and develop new technologies applicable to PCM to be used at manufacturing sites

• Fluent in written and spoken English

Additional Preferences:

International travel to Lilly and supplier sites is required (< 25%).

Education Requirements:

Bachelor’s degree in science/engineering, material science, chemical/biomedical engineering, chemistry, pharmaceutics or related field.

Location Requirements: This position is expected to be on site (i.e., no remote work flexibility), but could be hosted at manufacturing sites outside the US.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected].