Sr. Principal Scientist - Sterility Assurance Floor Leader

Overview

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 work to discover and bring medicines to those who need them, improve understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for individuals determined to make life better for people around the world.

For 140 years, Lilly has manufactured medicines that improve people’s lives worldwide. We use sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in processes, standards, procedures and behaviors to develop medicines with safety first and quality always.

• Lead, develop, coach, and mentor a team of sterility assurance scientists (process team) to ensure technical depth and an engaged, inclusive workforce.
• Foster a collaborative workplace and ensure effective hiring and staffing.
• Provide day-to-day oversight for the sterility assurance scientists (process team) associated with routine operations and start-up/project objectives.
• Provide technical expertise and guidance in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.
• Collaborate cross-functionally with area process teams for operational support and provide technical guidance for root cause investigations and deviation management.
• Lead sterility assurance related technical projects to improve process control, yield, product quality, and productivity.
• Author, review, and approve site plans, studies, and technical documents related to sterility assurance.
• Use risk management principles to evaluate processes and controls related to sterility assurance.
• Analyze microbial and manufacturing data using statistical principles to identify trends and process disruptions.
• Ensure audit and inspection readiness; support regulatory inspections, submissions, and partner/internal audits.

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
• Prior experience in cross-functional technical leadership roles.
• In-depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance.
• 5+ years supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.).

• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.
• Strong oral and written communication skills that clearly and succinctly communicate with all levels of the organization.
• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations.
• Demonstrated successful leadership of cross-functional teams.
• Experience with data trending and analysis; ability to analyze complex data and solve problems.

• This position is tech ladder approved (R4).
• This position will be required to collaborate with peers across the network (Indianapolis, EU, RTP, etc.).
• Role is Monday through Friday. Must be flexible to provide support to production schedules, shutdowns, and occasional extended hours or off-hour work as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job requirements may change over time and may include additional responsibilities not described here. For GMP purposes, update the job description for significant changes. Consult with your supervisor regarding your actual job responsibilities and related duties.

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, please complete the accommodation request form () for further assistance. This is for accommodation requests as part of the application process.

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.

Actual compensation will depend on a candidate’s education, experience, and location. The anticipated wage for this position is $117,000 - $171,600. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program, including medical, dental, vision, retirement plans, paid time off, flexible benefits, life insurance, and well-being programs. Lilly reserves the right to amend compensation and benefits programs.

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