Eli Lilly and Company · 6 hours ago
Senior / Principal Scientist - Sterility Assurance
Concord, NC
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Senior / Principal Sterility Assurance Scientist role involves developing and implementing sterility assurance programs, providing technical guidance in contamination control, and ensuring compliance with quality standards in pharmaceutical manufacturing.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification
Lead and/or provide technical oversight for developing the site’s environmental monitoring program, aseptic process simulation program
Lead and/or provide technical oversight for developing the site’s contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies
Provide technical expertise and/or oversight for the facility’s cleanroom gowning and aseptic technique strategy/program
Assist with providing sterility assurance expertise for site procedures, processes, protocols, validations, and technical studies
Author and evaluate sterility assurance risk assessments to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Assist in the development and implementation of site process flows to ensure effective contamination control strategies are established
Lead or provide technical support for root cause investigations associated with sterility assurance programs
Participate and/or provide technical sterility assurance support during internal and external audits
Create, execute, and/or review/evaluate technical documents and change controls related to sterility assurance programs
Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives
Qualification
Required
Bachelor's or master's degree in microbiology, Biology, Biochemistry, or other related scientific discipline
Minimum of 2 years' experience working in sterile pharmaceutical manufacturing within a Microbiology, Technical Services/Manufacturing Sciences, Sterility Assurance, or other related department with applicable experience in Sterility Assurance programs/strategies
Relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing
Preferred
Possess strong interpersonal skills to work cross-functionally within a team
Possess strong self-management and organizational skills
Possess strong technical writing skills
Possess strong oral and written communication skills for communicating to colleagues, management, and other departments
Experience with data analysis and trending
Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities
Benefits
Company bonus (depending, in part, on company and individual performance)
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
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 (404)
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