Job Information
Lilly Analyst – QC Chemistry and Device in Durham, North Carolina
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.
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. 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 of safe and efficacious drug and device products, through effective execution of product testing.
A laboratory Chemistry and Device Testing Analyst performs accurate and timely testing of routine lab samples and stability samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The Analyst will perform laboratory testing techniques including but not limited to UV-VIS, HPLC, Device testing, Turbidity, Appearance, compendial analysis (pH, Color, Clarity, Osmolality), utilities testing (TOC), testing of nitrates. The Analyst will review and interpret results and will perform second person verification (SPV) of analytical data. The analyst will also participate with Method Transfer activities to support product Launches at the Raleigh-Durham site. The analyst will author/revise and approve standard operating procedures. The analyst will be responsible to ensure their training is maintained daily and ensure site compliance. The Analyst 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.
Responsibilities:
Accurately and safely perform analytical test methods or related support activities as per procedures and/or protocols.
Accurately record data in reports or LIMS in accordance with laboratory procedures, standards, and GMP requirements.
Recognizes deviations from procedures, methods, etc., and initiates investigations as required.
Review analytical data generated by other analysts within the lab as required.
Adhere to all Environmental, Health, and Safety standards.
Identify and communicate opportunities for improvement initiatives in daily work activities.
Troubleshoot equipment and methods as required.
Expected to support their peers to meet project deliverables.
Support lean lab and 5S initiatives.
Understand the scientific principles required for testing of drug substances (DS) and drug product (DP), including the interaction of the chemistry and lab equipment.
Provide technical support for non-routine (e.g., deviation) investigations.
Maintain inventory of all supplies and consumables for the laboratory.
Maintain a clean and safe work lab work environment
Basic Requirements:
Bachelor (4-year college) degree in a life or applied science (Chemistry preferred).
1+ years of relevant, hands-on experience working within a GMP Laboratory.
Additional Skills/Preferences:
Experience with electronic laboratory management systems (E.g., LIMS, ELN, LES)
Experience with Empower3 and TrackWise (change controls, deviations).
Laboratory experience with HPLC and UV/VIS, Osmometer, TOC, pH meter, CE instruments.
Experience with medical device testing, including variables and attributes testing.
Experience with Capillary Electrophesis (CE).
Demonstrated problem solving and analytical thinking skills.
Understanding of statistical tools and analysis.
Excellent interpersonal skills and networking skills.
Strong attention to detail and self-motivated.
Ability to organize and prioritize multiple tasks.
Experience with lean lab and the 5S concept.
Experience with Root Cause Analysis.
Demonstrated ability to work both independently and as a part of a Team.
Strong organizational skills.
Strong verbal and written communication skills.
Able to provide on call support, as required.
Additional Information:
8-hour days – Monday through Friday, with on-call support as needed in support of a 24/7 manufacturing operation.
Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Tasks may require repetitive motion (e.g., keyboarding).
Minimal travel required
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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