350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
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LILilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Alzey
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
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Associate Director TSMS Sterility Assurance(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Senior Manager Microbiology Laboratory(m/w/x)
Vollzeitnur vor OrtManagementAlzey
LILilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Alzey
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Lilly
Branche
Healthcare
Beschreibung
The company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
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Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior/Principal Scientist Validation(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Senior Manager Microbiology Laboratory(m/w/x)
Vollzeitnur vor OrtManagementAlzey