Materials Management Scientist/Snr Scientist – Technical Services/Manufacturing Sciences

Job title:

Materials Management Scientist/Snr Scientist – Technical Services/Manufacturing Sciences

Company

Eli Lilly

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 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.Owing to the continuous growth of our Monoclonal pipeline of products, Eli Lilly & Company has invested in a new facility in Ireland, Lilly Limerick. To support this exciting new investment and meet the requirements of a safe and successful start-up, we are eager for talented individuals to join our team(s) and contribute to establishing Lilly Limerick as a reliable supplier of our innovative medicines and our goal of making a difference to people’s lives.If you are looking for a challenging, rewarding career and feel you meet the requirements listed below we would love to consider you for a role at Lilly, Limerick.Materials Management Scientist/Snr Scientist – Technical Services/Manufacturing SciencesThe Materials Management Scientist will provide technical oversight of raw materials and consumables utilized during the manufacture of monoclonal antibodies and fusion proteins to ensure the reliable supply of material with safety first and quality always. Scope of work includes qualification, implementation, continuous improvement, investigation support and technology transfer. This position will interact with Engineering, Operations, Quality Assurance, Quality Control, Procurement and Regulatory departments in Limerick and globally as well as with external suppliers. Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required.Key Responsibilities

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, especially as concerns the impact of material attributes on process chemistry & product protection.
• Serve as scientific liaison between the Materials/Procurement Process Team and Process Scientist.
• Establish and own the site’s extractables and leachables program to create documented risk assessments to enable manufacturing start
• Work with the Materials/Procurement Process Team to:

• Assess materials & supplier risk
• Audit suppliers
• Assess & address impact of supplier changes (drawing input from affected flow(s) scientific SMEs)
• Develop robust control strategies to manage supplier/material risk.

• Prepare, review, approve and provide technical support for preparation of relevant technical documents such as change controls, deviation investigations, plant trial protocols and summary reports, procedures, technical reports, etc.
• Lead and/or coordinate materials investigations and changes.
• Collaborate with site and global resources to support materials related laboratory studies
• Own (or provide input to) materials components of Annual Product Reviews, Management System Reviews, etc.
• Work with manufacturing Process Team counterparts to assess/investigate materials issues and implement materials changes.

Attributes for the Role

• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated strong interpersonal skills
• Demonstrated strong verbal and written communication skills
• Demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated ability to participate in and facilitate decision-making
• Proficient in English

Educational Requirements:

• Hons Degree Qualified BSc, MSc, or PhD degree based in biotechnology, biochemistry, chemistry or similar discipline.
• Experience (

5 yrs) working in a GMP or GLP manufacturing environment and with external vendorsWork Environment:

• Occasional travel will be necessary to support supplier visits and audits

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 ( ) 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 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.#WeAreLilly

Expected salary

Location

Limerick

Job date

Tue, 24 Dec 2024 23:15:45 GMT

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