Eli Lilly and Company
Organization 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 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. Key Objectives / Deliverables
Understand the scientific principles required for manufacturing and testing of intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Develop, monitor, and appropriately react to established statistically based metrics in real‑time to assess analytical vs. process variability and capability. Provide technical support to non‑routine (e.g., deviation) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validation Protocols, Tickets, Procedures, PFDs, Periodic Quality Evaluations, etc. Support production floor operations through change proposals, investigations, and deviation root cause analysis. Maintain and improve quality systems including method remediation. Participate in self‑assessments and regulatory agency inspections. Ensure internal and external quality and supply commitments are met. Manage the review and retention of cGMP documents. Must follow data integrity practices and procedures (ALCOA + principles). Basic Requirements
Bachelor’s Degree in a science related field. Additional Preferences
Demonstrated strong problem solving and analytical thinking skills. Understanding of statistical tools and analysis. Excellent interpersonal skills and networking skills. Experience in QA, QC, Manufacturing, Tech Services, or Regulatory Affairs. Demonstrated strong written and verbal communications skills. Strong attention to detail. Ability to organize and prioritize multiple tasks. Experience and knowledge of cGMP requirements. Familiarity with wet chemistry techniques, HPLC, GC, FTIR, UV/Vis, Titrations. Other Information
Must complete applicable Learning Plan. Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Overtime or on‑call hours may be required in order to meet business needs. Unless approved by leadership, Chemist‑QC‑IAPI is considered an on‑site position. Must adhere to policies and guidelines outlined in the employee handbook and Red Book. 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.
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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. Key Objectives / Deliverables
Understand the scientific principles required for manufacturing and testing of intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Develop, monitor, and appropriately react to established statistically based metrics in real‑time to assess analytical vs. process variability and capability. Provide technical support to non‑routine (e.g., deviation) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validation Protocols, Tickets, Procedures, PFDs, Periodic Quality Evaluations, etc. Support production floor operations through change proposals, investigations, and deviation root cause analysis. Maintain and improve quality systems including method remediation. Participate in self‑assessments and regulatory agency inspections. Ensure internal and external quality and supply commitments are met. Manage the review and retention of cGMP documents. Must follow data integrity practices and procedures (ALCOA + principles). Basic Requirements
Bachelor’s Degree in a science related field. Additional Preferences
Demonstrated strong problem solving and analytical thinking skills. Understanding of statistical tools and analysis. Excellent interpersonal skills and networking skills. Experience in QA, QC, Manufacturing, Tech Services, or Regulatory Affairs. Demonstrated strong written and verbal communications skills. Strong attention to detail. Ability to organize and prioritize multiple tasks. Experience and knowledge of cGMP requirements. Familiarity with wet chemistry techniques, HPLC, GC, FTIR, UV/Vis, Titrations. Other Information
Must complete applicable Learning Plan. Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Overtime or on‑call hours may be required in order to meet business needs. Unless approved by leadership, Chemist‑QC‑IAPI is considered an on‑site position. Must adhere to policies and guidelines outlined in the employee handbook and Red Book. 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.
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