350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Full-timeOn-siteSenior
Alzey
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LILilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Alzey
Full-timeOn-siteManagement
Nejo AI Summary
Evaluating manufacturing processes for parenteral drug products, managing microbial risk strategies. In-depth knowledge of parenteral drug product manufacturing and cGMP required. Creative freedom in scientific approach.
Requirements
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Prior experience in cross-functional technical leadership roles
- In-depth knowledge of parenteral drug product manufacturing with focus on Sterility Assurance
- 5+ years supporting cGMP manufacturing
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Facility start-up and/or technical transfer experience
- Demonstrated successful leadership of cross-functional teams
- Experience with data trending and analysis
- Ability to analyze complex data and solve problems
Tasks
- Provide leadership for technical and administrative issues
- Manage performance and development of staff
- Understand scientific principles for manufacturing parenteral drug products
- Evaluate manufacturing processes using sterility assurance risk management
- Assist in developing and executing monitoring strategies for microbial risk
- Support start-up activities for sterility assurance programs
- Ensure compliance with environmental monitoring and sterility assurance programs
- Guide the Process Team in sterility assurance and root cause investigations
- Analyze microbial and manufacturing data to identify trends and improvements
- Review environmental monitoring data periodically
- Lead risk assessments for sterility assurance programs
- Create and approve technical documents for sterility assurance
- Evaluate change controls related to sterility assurance programs
- Educate self and others on regulatory expectations and industry trends
- Participate in continuous improvement projects for quality performance
- Define and maintain inspection readiness activities
- Interact with regulatory agencies during inspections
- Support technical projects to improve process control and product quality
- Serve as the sterility assurance interface for the Alzey site
- Lead cross-functional teams to achieve TS/MS objectives
- Collaborate with partners across the Parenteral Network
- Ensure a safe working environment and improve safety culture
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lilly and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- 350 Lilly Deutschland GmbH
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LILilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Alzey
Full-timeOn-siteManagement
Nejo AI Summary
Evaluating manufacturing processes for parenteral drug products, managing microbial risk strategies. In-depth knowledge of parenteral drug product manufacturing and cGMP required. Creative freedom in scientific approach.
Requirements
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- Prior experience in cross-functional technical leadership roles
- In-depth knowledge of parenteral drug product manufacturing with focus on Sterility Assurance
- 5+ years supporting cGMP manufacturing
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Strong oral and written communication skills
- Facility start-up and/or technical transfer experience
- Demonstrated successful leadership of cross-functional teams
- Experience with data trending and analysis
- Ability to analyze complex data and solve problems
Tasks
- Provide leadership for technical and administrative issues
- Manage performance and development of staff
- Understand scientific principles for manufacturing parenteral drug products
- Evaluate manufacturing processes using sterility assurance risk management
- Assist in developing and executing monitoring strategies for microbial risk
- Support start-up activities for sterility assurance programs
- Ensure compliance with environmental monitoring and sterility assurance programs
- Guide the Process Team in sterility assurance and root cause investigations
- Analyze microbial and manufacturing data to identify trends and improvements
- Review environmental monitoring data periodically
- Lead risk assessments for sterility assurance programs
- Create and approve technical documents for sterility assurance
- Evaluate change controls related to sterility assurance programs
- Educate self and others on regulatory expectations and industry trends
- Participate in continuous improvement projects for quality performance
- Define and maintain inspection readiness activities
- Interact with regulatory agencies during inspections
- Support technical projects to improve process control and product quality
- Serve as the sterility assurance interface for the Alzey site
- Lead cross-functional teams to achieve TS/MS objectives
- Collaborate with partners across the Parenteral Network
- Ensure a safe working environment and improve safety culture
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lilly and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Lilly
Industry
Healthcare
Description
The company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need.
Not a perfect match?
- 350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
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Associate Director TSMS Sterility Assurance(m/w/x)
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Senior Manager Microbiology Laboratory(m/w/x)
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