350 Lilly Deutschland GmbH
Scientist – Sterility Assurance - Technical Services/Manufacturing Science(m/w/x)
Vollzeit
Senior
Keine Angabe
Alzey
35
350 Lilly Deutschland GmbH15 Tage
Sterility Assurance Advisor- Technical Services/Manufacturing Science (TS/MS)(m/w/x)
Vollzeit
Senior
Keine Angabe
Alzey
Nejo KI-Zusammenfassung
In this role, you will lead efforts to ensure sterility assurance for parenteral products, with a focus on compliance, process optimization, and scientific understanding. Your daily responsibilities will include evaluating risks, mentoring team members, and representing the site during audits.
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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
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
7 Jahre
Deine 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
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.
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