TSMS Sterility Assurance Scientist at Eli Lilly and Company

Pleasant Prairie, Wisconsin, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification (Principal level)
Ability to apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Capability to analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements

Responsibilities

Provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level (Associate/Senior)
Lead or provide technical oversight/support for activities related to sterility assurance programs including airflow pattern testing, environmental monitoring performance qualifications, aseptic process simulations, cleaning/sanitization/disinfection, gowning within GMP classified areas, aseptic processing techniques, and contamination control (Associate/Senior)
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies (Associate/Senior)
Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies (Senior)
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 (Senior)
Lead/assist with support and/or provide technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program (Senior)
Lead/provide technical oversight for Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program (Principal): Authoring EM PQ and overseeing execution; evaluating EM data and authoring trend reports; assisting with identifying facility environmental isolates and maintaining cultures; authoring APS protocols and overseeing execution; evaluating APS data including personnel qualifications and authoring reports; tracking and tending APS to meet regulatory and quality standards
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
Serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance (Principal)
Provide technical leadership for the Parenteral Process Team (Principal)

Skills

Environmental Monitoring

Contamination Control

Aseptic Process Simulations

Gowning Techniques

Cleaning Sanitization

Disinfectant Efficacy

Airflow Pattern Testing

GMP

Aseptic Processing

Sterility Assurance

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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