350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
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35350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH 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?
- Lilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Vollzeitnur vor OrtManagementAlzey - Lilly Deutschland GmbH
Site Molecule Steward(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Scientist – TSMS Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSeniorAlzey
35350 Lilly Deutschland GmbH
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH 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
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
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - Lilly
Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Vollzeitnur vor OrtManagementAlzey - Lilly Deutschland GmbH
Site Molecule Steward(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Scientist – TSMS Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSeniorAlzey