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Responsible Scientist – QC Microbiology Lab(m/w/x)
Technical review of raw material data, product release, analyst training at a global pharmaceutical company. 5-10 years GMP Microbiology Lab experience, proficiency in endotoxin, bioburden, sterility analysis required. Excellent company pension plan, access to Corporate University.
Anforderungen
- Master's or bachelor's degree with extensive relevant work experience in a science field related to microbiology
- 5-10 years of demonstrated relevant experience in a GMP, Microbiology Laboratory
- Demonstrated proficiency in laboratory analysis including endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification
- Strong oral and written communication skills
- Fluency in English and German
Aufgaben
- Perform technical review and interpretation of raw material data
- Release in-process and finished product data
- Contribute to annual product reviews and process validations
- Conduct technical training and mentor analysts
- Initiate and author change controls and deviations
- Lead investigations into out of spec results
- Perform root cause analysis and recommend solutions
- Develop investigational testing protocols
- Execute method verifications, transfers, and validations
- Monitor method and process performance
- Improve lab quality systems and approve SOPs
- Contribute to Global Lab Quality Standards implementation
- Comply with safety standards
- Provide oversight for Periodic Management Reviews
- Communicate effectively with business partners
- Notify management of quality issues
- Participate in internal and external audits
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to Corporate Lilly University
Noch nicht perfekt?
- 350 Lilly Deutschland GmbHVollzeitnur vor OrtManagementAlzey
- 350 Lilly Deutschland GmbH
Senior Manager - Quality Control Environmental Monitoring(m/w/x)
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Senior Manager Chemical Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager Device and Incoming Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Microbiologist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey
Responsible Scientist – QC Microbiology Lab(m/w/x)
Technical review of raw material data, product release, analyst training at a global pharmaceutical company. 5-10 years GMP Microbiology Lab experience, proficiency in endotoxin, bioburden, sterility analysis required. Excellent company pension plan, access to Corporate University.
Anforderungen
- Master's or bachelor's degree with extensive relevant work experience in a science field related to microbiology
- 5-10 years of demonstrated relevant experience in a GMP, Microbiology Laboratory
- Demonstrated proficiency in laboratory analysis including endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification
- Strong oral and written communication skills
- Fluency in English and German
Aufgaben
- Perform technical review and interpretation of raw material data
- Release in-process and finished product data
- Contribute to annual product reviews and process validations
- Conduct technical training and mentor analysts
- Initiate and author change controls and deviations
- Lead investigations into out of spec results
- Perform root cause analysis and recommend solutions
- Develop investigational testing protocols
- Execute method verifications, transfers, and validations
- Monitor method and process performance
- Improve lab quality systems and approve SOPs
- Contribute to Global Lab Quality Standards implementation
- Comply with safety standards
- Provide oversight for Periodic Management Reviews
- Communicate effectively with business partners
- Notify management of quality issues
- Participate in internal and external audits
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to Corporate Lilly University
Über das Unternehmen
350 Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Senior Manager Microbiology Laboratory(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Senior Manager - Quality Control Environmental Monitoring(m/w/x)
Vollzeitnur vor OrtManagementWiesbaden, Alzey - 350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager Device and Incoming Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Microbiologist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey