Eli Lilly and Company · 9 hours ago
Sr. Principal Scientist - Sterility Assurance Floor Leader
Concord, NC
Full-time
Onsite
Senior Level, Lead/Staff
$117K/yr - $172K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, committed to improving lives through innovative medicines. The Sr. Principal Scientist - Sterility Assurance Floor Leader will provide technical leadership and mentorship to a team of scientists, ensuring compliance with regulatory standards and improving sterility assurance strategies in manufacturing processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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 the 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
Qualification
Required
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other 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.)
Preferred
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, 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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2025-12-30
2025-12-30
Company data provided by crunchbase