Eli Lilly and Company · 2 days ago
Scientist / Senior Scientist - TSMS Sterility Assurance
Concord, NC
Full-time
Onsite
Mid, Senior Level
$66K/yr - $172K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and bringing life-changing medicines to those in need. The Sterility Assurance Scientist role involves assisting in the development and implementation of sterility assurance programs, providing technical guidance in contamination control, and supporting aseptic processes to ensure product safety and quality.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level
Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to; Airflow Pattern Testing, Environmental Monitoring Performance Qualifications, Aseptic Process Simulations, Cleaning, Sanitization, and Disinfection, Gowning within GMP Classified Areas, Aseptic Processing Techniques, Contamination Control
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
Lead/assist with support and/or provide technical expertise for developing the site’s contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies
Lead/assist with support and/or provide technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements
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, review, and/or approve 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, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Demonstrated understanding and 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 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
401(k)
Pension
Vacation benefits
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.
Founded in 1876
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
2026-01-06
2026-01-06
Company data provided by crunchbase