Scientist - TS/MS - Sterility Assurance Technology at Eli Lilly and Company

Indianapolis, Indiana, 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

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Bachelor’s degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing experience
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Responsibilities

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 Flow level
Provide technical guidance to the Flow and Process Teams for sterility assurance programs
Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews
Lead or provide technical support for root cause investigations for sterility assurance programs
Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk
Lead site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, justification documents, protocols, and summary reports
Create, execute and/or review 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 regulatory audits
Provide content and/or data integrity reviews for regulatory submissions
Lead training courses related to sterility assurance programs

Skills

Environmental Monitoring

Aseptic Process Simulations

Facility Cleaning

Facility Sanitization

Sterility Assurance Risk Management

Sterility Assurance Programs

Technical Leadership

Data Review

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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