Sr. Principal Microbiologist
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: Lilly has an exciting opportunity to join QC Microbiology Department at the RTP Campus. We are seeking a highly experienced and motivated Sr. Principal Microbiologist. This position 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 new laboratory technologies and associated 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.
Requirements
- Bachelor (4-year college) degree in life of physical science (Microbiology or Biology, preferred).
- Relevant experience working in a microbiology laboratory.
- Experience in a GMP environment.
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
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
Principal
