Principal Chemist - QC

Eli Lilly and Company; Concord (NC); On-site; USD 63,000 - 163,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control Chemist to join their team. In this vital role, you will conduct laboratory testing and analyses, ensuring compliance with GMP standards while supporting production and stability requirements. You'll utilize your technical skills to investigate atypical results and contribute to continuous improvement initiatives. This is a fantastic opportunity to work in a collaborative environment where your expertise can lead to significant advancements in healthcare. If you're passionate about making a difference and thrive in a dynamic lab setting, we want to hear from you!

Benefits

401(k) Plan

Pension

Vacation Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Life Insurance

Employee Assistance Program

Fitness Benefits

Qualifications

• Bachelor's or Master's degree in Chemistry, Biology, or related field required.
• Minimum 1 year of experience in a GMP laboratory setting.

Responsibilities

• Perform accurate testing of lab samples in compliance with GMP guidelines.
• Review and interpret data, document results, and assist in investigations.

Skills

Laboratory Analysis

Problem-Solving Skills

Communication Skills

Root Cause Analysis

Education

Bachelor's or Master's in Science or Engineering

Tools

HPLC

UV-Vis Spectroscopy

Empower

LabVantage LIMS

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.

Responsibilities

The Quality Control Chemist performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The Quality Control Chemist will perform laboratory testing techniques including but not limited to UV-Vis, HPLC, device testing and perform compendial analysis (for example: pH, Color, Clarity, Osmolality). The Quality Control Chemist will review and interpret results and utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results.

Key Objectives/Deliverables:

• Participate in the transfer of analytical methods for marketed products, including authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.
• Perform routine laboratory analyses.
• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in accordance with GMP and local guidelines.
• Initiate and author change controls and minor deviations. (Senior and Principal Chemist roles)
• Utilizes technical skills to perform in-depth investigations associated with out-of-specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. (Senior and Principal Chemist roles)
• Assist with development of investigational testing protocols and perform testing as required. (Senior and Principal Chemist roles)
• Author SOPs and training documentation.
• Execute inspection readiness activities in the QC laboratories.
• Interact effectively with auditors and business partners.
• Train and mentor lab personnel.
• Support Lean Lab initiatives and efficient lab operations.
• Comply with and assist with implementing safety standards.

Basic Qualifications

• Bachelor or Masters degree in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• Demonstrated proficiency in laboratory analysis.
• Previous experience with LC instruments, enterprise chromatography systems and standalone COTS testing instruments.
• Experience in a GMP laboratory.
• Chemist: Minimum 1 year of relevant experience.
• Senior Chemist: Minimum 3 years of relevant experience.
• Principal Chemist: Minimum 5 years of relevant experience.

Additional Skills/ Preferences

• Experience with Empower and LabVantage LIMS.
• Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
• Demonstrated problem-solving skills.
• Training and experience in Root Cause Analysis methodology.
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

Additional Information

• Tasks may require repetitive motion and standing for long periods of time.
• 8-hour days – Monday through Friday.
• Occasional shift work when required within the lab.

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 (here) for further assistance.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800. 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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