Sr. Principal Chemist - Quality Control

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 35,000 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 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 Chemist reviews, interprets, and releases analytical results for the laboratory in support of product/material batch release, in-process product testing, protocol driven testing and investigational testing. The Sr. Principal Chemist 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 Chemist 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 or repair activities. The Sr. Principal Chemist will be required to perform routine and non-routine laboratory testing and training and mentoring of laboratory personnel, as needed. The Sr. Principal Chemist will be required to utilize technical and regulatory expertise to assist in inspection/audit activities, laboratory investigations as well continuous improvement activities.

Responsibilities:

• 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 product and material properties relative to analytical attributes.
• Author technical documents.
• Participate in laboratory improvement initiates, as required.
• Review analytical data generated by other analysts within the lab as required.
• Provide regulatory expertise in support of internal and external auditing processes.
• Lead investigation processes, including root cause analysis and CAPA.

Basic Requirements:

• Bachelor (4-year college) degree in Chemistry, Biology or Microbiology and Relevant experience in a chemistry lab.

Additional Preferences:

• Excellent interpersonal skills and networking skills.
• Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN)
• Understanding of statistical tools and trend analysis.
• Strong self-management and organizational skills.
• Laboratory experience with HPLC and CE instruments.
• Demonstrated problem solving and analytical thinking skills.
• Demonstrated ability to work both independently and as a part of a Team.
• Demonstrated written and verbal communications skills.
• May be required to provide on call support.
• Experience with change control, analytical and deviation investigations, including root cause analysis and CAPA.
• Experience in a GMP environment.
• Experience with Empower3 and TrackWise.
• Strong attention to detail.

Additional Information

• Minimal travel required.
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
• 8-hour days – Monday through Friday.
• Tasks may require repetitive motion (E.g., keyboarding).
• 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.

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