Chemist - QC-IAPI
About The Position
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. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support 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 ).
Requirements
- Bachelor’s Degree in a science related field.
Nice To Haves
- 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
Responsibilities
- 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 ).
Benefits
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
