Roche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Vollzeitnur vor OrtManagement
Basel
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F.F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading formulation development for injectable drug products, including process scale-up and validation for clinical and launch. 6+ years industry experience with 2+ years in formulation development, BLA/NDA submission experience essential. Work on large-scale development projects for global market access.
Anforderungen
- Ph.D. or Master’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Chemical/Process Engineering, or related field
- Minimum 6 years professional industry experience
- At least 2 years experience in formulation and process development for parenteral dosage forms
- Proven experience authoring DP sections for BLA and/or NDA submissions
- Excellent communication skills
- Stakeholder management abilities
- End-to-end and global thinking
- Experience in drug delivery systems (strong advantage)
- Experience in associated analytical techniques (strong advantage)
Aufgaben
- Lead parenteral formulation development for clinical, launch, and line extensions
- Develop robust manufacturing processes for parenteral formulations
- Perform scale-up of manufacturing processes
- Conduct process characterization
- Execute process validation
- Transfer processes to global commercial sites
- Serve as Pharmaceutical Project Leader for global CMC teams
- Represent function in cross-functional teams
- Represent function in international committees
- Author global regulatory submissions for Phases 1-3
- Author market applications (BLA, MAA, NDA)
- Provide critical input for global regulatory submissions
- Provide critical input for market applications (BLA, MAA, NDA)
- Evaluate program and submission risks from drug product standpoint
- Collaborate to transfer products to commercial manufacturing
- Collaborate to transfer processes to commercial manufacturing
Berufserfahrung
- 6 Jahre
Ausbildung
- 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 F. Hoffmann-La Roche AG 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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F.F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading formulation development for injectable drug products, including process scale-up and validation for clinical and launch. 6+ years industry experience with 2+ years in formulation development, BLA/NDA submission experience essential. Work on large-scale development projects for global market access.
Anforderungen
- Ph.D. or Master’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Chemical/Process Engineering, or related field
- Minimum 6 years professional industry experience
- At least 2 years experience in formulation and process development for parenteral dosage forms
- Proven experience authoring DP sections for BLA and/or NDA submissions
- Excellent communication skills
- Stakeholder management abilities
- End-to-end and global thinking
- Experience in drug delivery systems (strong advantage)
- Experience in associated analytical techniques (strong advantage)
Aufgaben
- Lead parenteral formulation development for clinical, launch, and line extensions
- Develop robust manufacturing processes for parenteral formulations
- Perform scale-up of manufacturing processes
- Conduct process characterization
- Execute process validation
- Transfer processes to global commercial sites
- Serve as Pharmaceutical Project Leader for global CMC teams
- Represent function in cross-functional teams
- Represent function in international committees
- Author global regulatory submissions for Phases 1-3
- Author market applications (BLA, MAA, NDA)
- Provide critical input for global regulatory submissions
- Provide critical input for market applications (BLA, MAA, NDA)
- Evaluate program and submission risks from drug product standpoint
- Collaborate to transfer products to commercial manufacturing
- Collaborate to transfer processes to commercial manufacturing
Berufserfahrung
- 6 Jahre
Ausbildung
- 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 F. Hoffmann-La Roche AG 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
F. Hoffmann-La Roche AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Noch nicht perfekt?
- Roche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Vollzeitnur vor OrtManagementBasel - F. Hoffmann-La Roche AG
Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Section Lead & Center of Excellence (CoE) Strategy Realization(m/w/x)
Vollzeitnur vor OrtManagementBasel - 1201 F. Hoffmann-La Roche AG
Senior Crystallization Specialist / Particle Engineer(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
CMC Expert Analytical Development focus Parenterals&Devices(m/w/x)
Vollzeitnur vor OrtManagementBasel