MS&T Director, Validation Lead Steriles
Thermo Fisher ScientificSalary not specified
- Full Time
- Senior (5 to 8 years)
Eli Lilly and Company
Scientist – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalIndustries
Requirements
Candidates should possess a Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field, and a Master’s degree is preferred. A minimum of 5 years of experience in sterility assurance, manufacturing science, or related roles is required, with demonstrated expertise in aseptic processing, environmental monitoring, and contamination control strategies. Strong knowledge of parenteral drug product manufacturing, including aseptic processing, is essential. Experience with sterility assurance risk management principles and statistical data analysis is also necessary.
Responsibilities
The Scientist – Sterility Assurance – Technical Services / Manufacturing Science (TS/MS) will develop and implement site-related sterility assurance initiatives, providing technical leadership in sterility assurance and environmental monitoring strategies. This role involves supporting manufacturing operations, particularly during syringe filling, by providing technical support for start-up activities, evaluating disinfectants and sanitizers, conducting environmental monitoring, and leading risk assessments. The scientist will also assist in the development of process and facility monitoring strategies, analyze microbial and manufacturing data, and provide technical guidance to the Process Team, ultimately ensuring adherence to site’s sterility assurance programs and contributing to continuous improvement efforts.
Skills
Aseptic Processing
Environmental Monitoring
Contamination Control
Parenteral Drug Product Manufacturing
Sterility Assurance Risk Management
Statistical Data Analysis
Microbial Testing
Risk Assessment
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.
Key Metrics
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees