Eli Lilly and Company
Sr. Scientist- QC
Eli Lilly and Company, Lebanon, Indiana, United States, 46052
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:
Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.Position Description:
The Scientist role in the Quality Control Laboratory is a technical position necessitating proficiency across multiple domains, including Bioassay, product testing Microbiology, and Chemistry. The Scientist is responsible for conducting precise and prompt testing of both routine and select non-routine laboratory samples, adhering to applicable GMP and safety standards. Additionally, they perform second-person verification of results and engage in laboratory investigations to identify root causes, assess equipment, and implement qualifications. Furthermore, they contribute to quality system improvement initiatives by following well-defined protocols and procedures.Key Objectives/Deliverables:
Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.Use technical knowledge in the review and interpretation of data for conformance to procedures, standards, and protocols and / or real-time recognition of aberrant data and results.Second Person Verify (SPV) of analytical data generated in the laboratory.Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Troubleshoot equipment and methods as required.Assist in improvement of quality systems by creating or revising lab documentation systems.Share technical information and best practice within plant sites or group.Perform routine equipment standardizations through execution of well-defined protocols.Identify and communicate opportunities for improvement initiatives in daily work activities.Review SOPs for executable as written.Comply with and implement safety standards.Execute notification to management when required by procedures or standards.Recognize when a deviation from procedures has occurred and initiates and participates in a Root Cause Investigation.Train and mentor others. Develop training materials.Minimum Requirements:
A bachelor’s degree (4-year college) in a related scientific field (Biology, Biochemistry, Chemistry, Microbiology, etc.)3+ years of experience in Pharma QC labsMust pass eye exam and not be color blindAdditional Preferences:
Demonstrate strong math and documentation skills.Demonstrate strong oral and written communication and interpersonal interaction skills.Proficiency with computer systems including Microsoft Office products, LIMS, and etc.Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.Strong understanding of regulatory standards/requirements for a GMP Laboratory.Experience with some or all of the following analytical techniques: ddPCR, qPCR, HPLC (SEC, IEX, RP, etc.), CE-SDS, ELISA, Cell Culturing, Endotoxin, Bioburden, Growth Promotion, Sterility Testing, Sub-visible Particulates, Wet Chemistry, and CCIT.Other Information:
May be required to perform testing to support manufacturing during off hours on a rotating schedule.Applicant will work in various areas within the LP2 site. Some allergens are present in the site and Laboratory. Mobility requirements and exposure to allergens should be considered when applying for this position.Tasks may require repetitive motion (e.g., keyboarding, pipetting, plating, etc.).
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Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.Position Description:
The Scientist role in the Quality Control Laboratory is a technical position necessitating proficiency across multiple domains, including Bioassay, product testing Microbiology, and Chemistry. The Scientist is responsible for conducting precise and prompt testing of both routine and select non-routine laboratory samples, adhering to applicable GMP and safety standards. Additionally, they perform second-person verification of results and engage in laboratory investigations to identify root causes, assess equipment, and implement qualifications. Furthermore, they contribute to quality system improvement initiatives by following well-defined protocols and procedures.Key Objectives/Deliverables:
Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.Use technical knowledge in the review and interpretation of data for conformance to procedures, standards, and protocols and / or real-time recognition of aberrant data and results.Second Person Verify (SPV) of analytical data generated in the laboratory.Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Troubleshoot equipment and methods as required.Assist in improvement of quality systems by creating or revising lab documentation systems.Share technical information and best practice within plant sites or group.Perform routine equipment standardizations through execution of well-defined protocols.Identify and communicate opportunities for improvement initiatives in daily work activities.Review SOPs for executable as written.Comply with and implement safety standards.Execute notification to management when required by procedures or standards.Recognize when a deviation from procedures has occurred and initiates and participates in a Root Cause Investigation.Train and mentor others. Develop training materials.Minimum Requirements:
A bachelor’s degree (4-year college) in a related scientific field (Biology, Biochemistry, Chemistry, Microbiology, etc.)3+ years of experience in Pharma QC labsMust pass eye exam and not be color blindAdditional Preferences:
Demonstrate strong math and documentation skills.Demonstrate strong oral and written communication and interpersonal interaction skills.Proficiency with computer systems including Microsoft Office products, LIMS, and etc.Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.Strong understanding of regulatory standards/requirements for a GMP Laboratory.Experience with some or all of the following analytical techniques: ddPCR, qPCR, HPLC (SEC, IEX, RP, etc.), CE-SDS, ELISA, Cell Culturing, Endotoxin, Bioburden, Growth Promotion, Sterility Testing, Sub-visible Particulates, Wet Chemistry, and CCIT.Other Information:
May be required to perform testing to support manufacturing during off hours on a rotating schedule.Applicant will work in various areas within the LP2 site. Some allergens are present in the site and Laboratory. Mobility requirements and exposure to allergens should be considered when applying for this position.Tasks may require repetitive motion (e.g., keyboarding, pipetting, plating, etc.).
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