Eli Lilly and Company · 4 hours ago
Sterility Assurance Scientist
US: Research Triangle Park NC
Full-time
Onsite
Mid Level
$66K/yr - $172K/yrEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Sterility Assurance Scientist role involves developing and implementing sterility assurance strategies for a new manufacturing site, focusing on compliance and quality in the production of parenteral drug products.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk
Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
Provide technical guidance to the Process Team for sterility assurance programs
Lead or provide technical support for root cause investigations related to sterility assurance programs
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
Perform periodic review of environmental monitoring data
Lead or support risk assessments related to sterility assurance programs
Create, execute, review, and/or approve technical documents related to sterility assurance programs
Create, execute, and/or evaluate change controls related to sterility assurance programs
Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
Participate in continuous improvement projects to improve quality performance at the site
Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
Serve as sterility assurance interface external to the RTP site
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities
Qualification
Required
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.)
Preferred
In depth knowledge of parenteral drug product manufacturing
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.
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
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2026-01-25
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2026-01-23
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