Dein persönlicher KI-Karriere-Agent
Analytical Lead and Expert Preclincal Bioassays(m/w/x)
Leading analytical activities for biologics, coordinating insulin-bioassays at external suppliers. 5+ years biopharmaceutical development and manufacturing experience required. 14-week paid family leave, childcare benefits.
Anforderungen
- 5+ years development and manufacturing biopharmaceutical products
- Experience in analytical sciences
- Experience with analytical transfers
- Experience with bioassays
- Experience with automation
- Experience with development
- Experience with regulatory requirements
- Experience with dossier writing
- cGMP knowledge
- HA regulations knowledge
- Interactions with HA
- Active decision-making
- Enjoyment of interdisciplinary collaboration
- Openness and winning with people
- Self-employment
- Organizational skills
- Purposefulness
- Ability to present complex contexts accurately
- Ability to present complex contexts comprehensibly
- Risk anticipation
- Proactive solutions
- Effective solutions
- Innovative solutions
- PhD or Master in Science
- Chemistry degree
- Biochemistry degree
- Biotechnology degree
- Chemical engineering degree
- Pharmacist degree
- Fluency in English writing
- Fluency in English verbally
- Fluency in German writing
- Fluency in German verbally
Aufgaben
- Serve as Analytical Lead for product teams
- Oversee analytical activities for biologics
- Coordinate insulin-bioassays at external suppliers
- Support new product launches
- Represent Global MSAT Analytical in CMC teams
- Maintain knowledge of assigned products
- Ensure analytical work execution internally and externally
- Support characterization, comparability, and process development
- Coordinate bioassay experiments at external suppliers
- Develop analytical control strategy
- Conduct risk assessments for new products
- Manage comparability activities for process changes
- Lead ALCM activities including automation
- Oversee assay development and transfer
- Provide SME support for assigned products
- Contribute to regulatory dossiers
- Respond to authority questions
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- High-quality healthcare
Mentale Gesundheitsförderung
- Prevention programs
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Mitarbeiterrabatte
- Company employee benefit programs
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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Analytical Lead and Expert Preclincal Bioassays(m/w/x)
Leading analytical activities for biologics, coordinating insulin-bioassays at external suppliers. 5+ years biopharmaceutical development and manufacturing experience required. 14-week paid family leave, childcare benefits.
Anforderungen
- 5+ years development and manufacturing biopharmaceutical products
- Experience in analytical sciences
- Experience with analytical transfers
- Experience with bioassays
- Experience with automation
- Experience with development
- Experience with regulatory requirements
- Experience with dossier writing
- cGMP knowledge
- HA regulations knowledge
- Interactions with HA
- Active decision-making
- Enjoyment of interdisciplinary collaboration
- Openness and winning with people
- Self-employment
- Organizational skills
- Purposefulness
- Ability to present complex contexts accurately
- Ability to present complex contexts comprehensibly
- Risk anticipation
- Proactive solutions
- Effective solutions
- Innovative solutions
- PhD or Master in Science
- Chemistry degree
- Biochemistry degree
- Biotechnology degree
- Chemical engineering degree
- Pharmacist degree
- Fluency in English writing
- Fluency in English verbally
- Fluency in German writing
- Fluency in German verbally
Aufgaben
- Serve as Analytical Lead for product teams
- Oversee analytical activities for biologics
- Coordinate insulin-bioassays at external suppliers
- Support new product launches
- Represent Global MSAT Analytical in CMC teams
- Maintain knowledge of assigned products
- Ensure analytical work execution internally and externally
- Support characterization, comparability, and process development
- Coordinate bioassay experiments at external suppliers
- Develop analytical control strategy
- Conduct risk assessments for new products
- Manage comparability activities for process changes
- Lead ALCM activities including automation
- Oversee assay development and transfer
- Provide SME support for assigned products
- Contribute to regulatory dossiers
- Respond to authority questions
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- High-quality healthcare
Mentale Gesundheitsförderung
- Prevention programs
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Mitarbeiterrabatte
- Company employee benefit programs
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Noch nicht perfekt?
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