350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Full-timeOn-siteSenior
Alzey
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35350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Sterility assurance strategy development for parenteral drug products in global pharmaceutical manufacturing. In-depth knowledge of parenteral processing and GMPs required. Environment focused on scientific understanding and process optimization.
Requirements
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- In-depth knowledge and understanding of GMPs and internal standards
- In-depth knowledge of parenteral processing
- In-depth knowledge of microbiology and sterility assurance
- In-depth knowledge of risk management and risk assessment tools
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Teamwork and interpersonal skills to effectively influence
- Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
- Prior experience in multiple functions associated with manufacture of parenteral products
- Minimum 7 years’ experience in the biopharmaceutical industry
- Advanced Degree in Microbiology, Biology or related scientific field preferred
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Tasks
- Develop and implement a technical agenda for sterility assurance
- Ensure reliable and compliant manufacturing of drug products
- Improve process control strategies and optimize technologies
- Enhance scientific understanding of sterility assurance
- Maintain a safe work environment and support HSE goals
- Understand scientific principles for manufacturing parenteral products
- Evaluate manufacturing processes for sterility assurance risks
- Lead complex projects related to sterility assurance programs
- Develop and execute monitoring strategies for microbial risk
- Conduct root cause analysis for major deviations in sterility assurance
- Stay updated on external regulatory requirements for sterility assurance
- Influence revisions to corporate guidance on sterility assurance
- Identify and implement continuous improvements in sterility assurance
- Provide design input for new processes and facilities
- Represent sterility assurance programs during audits and inspections
- Assist in writing regulatory submissions for sterility assurance
- Create and approve sterility assurance training for new hires
- Mentor less senior scientists within the TS/MS organization
- Offer technical consultation across the Parenteral Network
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH 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?
- Lilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Full-timeOn-siteManagementAlzey - 350 Lilly Deutschland GmbH
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Microbiologist(m/w/x)
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35350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Sterility assurance strategy development for parenteral drug products in global pharmaceutical manufacturing. In-depth knowledge of parenteral processing and GMPs required. Environment focused on scientific understanding and process optimization.
Requirements
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
- In-depth knowledge and understanding of GMPs and internal standards
- In-depth knowledge of parenteral processing
- In-depth knowledge of microbiology and sterility assurance
- In-depth knowledge of risk management and risk assessment tools
- Ability to analyze complex data and solve problems
- Strong technical writing and presentation skills
- Teamwork and interpersonal skills to effectively influence
- Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
- Prior experience in multiple functions associated with manufacture of parenteral products
- Minimum 7 years’ experience in the biopharmaceutical industry
- Advanced Degree in Microbiology, Biology or related scientific field preferred
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Tasks
- Develop and implement a technical agenda for sterility assurance
- Ensure reliable and compliant manufacturing of drug products
- Improve process control strategies and optimize technologies
- Enhance scientific understanding of sterility assurance
- Maintain a safe work environment and support HSE goals
- Understand scientific principles for manufacturing parenteral products
- Evaluate manufacturing processes for sterility assurance risks
- Lead complex projects related to sterility assurance programs
- Develop and execute monitoring strategies for microbial risk
- Conduct root cause analysis for major deviations in sterility assurance
- Stay updated on external regulatory requirements for sterility assurance
- Influence revisions to corporate guidance on sterility assurance
- Identify and implement continuous improvements in sterility assurance
- Provide design input for new processes and facilities
- Represent sterility assurance programs during audits and inspections
- Assist in writing regulatory submissions for sterility assurance
- Create and approve sterility assurance training for new hires
- Mentor less senior scientists within the TS/MS organization
- Offer technical consultation across the Parenteral Network
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH 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
350 Lilly Deutschland GmbH
Industry
Healthcare
Description
The company is a global healthcare leader dedicated to 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 - Lilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Full-timeOn-siteManagementAlzey - 350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Full-timeOn-siteManagementAlzey - Lilly Deutschland GmbH
Site Molecule Steward(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Microbiologist(m/w/x)
Full-timeOn-siteExperiencedAlzey