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.
The Sr. Principal Microbiologist reviews, interprets, and releases analytical results for the laboratory in support of product/material batch release, in-process product testing, utilities testing, environmental monitoring testing, protocol driven testing and investigational testing. The Sr. Principal Microbiologist leads method deployment activities, including authoring method validation, verification and/or transfer protocols and reports, supporting method familiarization/evaluation activities and providing oversight to associated project plans. Additionally, the Sr. Principal Microbiologist will lead or assist in the onboarding on laboratory instrumentation and equipment, including authoring/reviewing/executing change controls and related actions, authoring/reviewing IQ/OQ/PQ protocols and reports, authoring/reviewing standard operating procedures and training materials as well as working with and/or overseeing certified service providers during instrument installation and/or repair activities. The Sr. Principal Microbiologist will be required to perform routine and non-routine laboratory testing as well as providing primary support for training and mentoring of laboratory personnel, as needed. The Sr. Principal Microbiologist will be required to utilize technical and regulatory expertise to assist in inspection/audit related activities, laboratory investigations and continuous improvement initiatives.
- Review analytical data generated by laboratory personnel.
- Provide technical leadership within the laboratory team, cross-functionally and across sites.
- Provide technical knowledge relative to scientific principles required for testing of drug substance, drug product and raw materials including assessment of product/material properties relative to analytical attributes.
- Provide technical guidance to collaborative teams relative to utilities and environmental testing results and required actions.
- Lead investigations/deviations, including root cause analysis and SMART CAPA development/implementation.
- Lead and manage relationships with third party testing laboratories, as required.
- Provide regulatory expertise in support of internal and external auditing processes.
- Lead instrument and method deployment activities.
Requirements (Education, Experience, Training):
- Bachelor (4-year college) degree in life of physical science (Microbiology or Biology, preferred).
- Previous experience in a GMP environment
- Previous experience working in a microbiology laboratory.
- Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN, MODA)
- Experience with TrackWise.
- Laboratory experience with various microbiological techniques and instrumentation (E.g., Aseptic Techniques, Conductivity, TOC, Endotoxin, Bioburden, Microbial Enumeration, Sterility Testing, Microbial Identification, Particulate Matter).
- Experience in operational excellence, such as lean and 5S initiatives.
- Demonstrated problem solving and analytical thinking skills.
- Proficiency in use of statistical tools for trend analysis.
- Excellent interpersonal skills and networking skills.
- Strong self-management and organizational skills.
- Demonstrated written and verbal communications skills.
- Strong attention to detail.
- May be required to provide on call support.
- Demonstrated ability to work both independently and as a part of a Team.
- 8-hour days – Monday through Friday.
- May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
- 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.
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