Dein persönlicher KI-Karriere-Agent
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Developing and overseeing peptide parenteral formulations from scale-up to global commercial manufacturing at a large pharmaceutical company. Proven experience authoring NDA drug product sections and regulatory CMC documents required. Global project leadership within CMC teams.
Anforderungen
- Proven experience authoring NDA drug product sections
- Strong expertise in chemistry and solid state characterization
- Experience in peptide analytical techniques and aseptic manufacturing
- Direct experience in writing regulatory CMC documents
- Excellent communication and stakeholder management skills
- Ph.D. or master's degree in chemistry or related fields
Aufgaben
- Drive development of peptide parenteral formulations.
- Oversee manufacturing processes for peptide formulations.
- Manage scale-up, process characterization, and validation.
- Facilitate transfer to global commercial manufacturing sites.
- Act as Pharmaceutical Project Leader in CMC teams.
- Shape global regulatory submissions for all phases.
- Impact market approvals for life-changing medicines.
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Noch nicht perfekt?
- F. Hoffmann-La Roche AGVollzeitnur vor OrtSeniorBasel
- 1201 F. Hoffmann-La Roche AG
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Senior Crystallization Specialist / Particle Engineer(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Vollzeitnur vor OrtSeniorBasel
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Developing and overseeing peptide parenteral formulations from scale-up to global commercial manufacturing at a large pharmaceutical company. Proven experience authoring NDA drug product sections and regulatory CMC documents required. Global project leadership within CMC teams.
Anforderungen
- Proven experience authoring NDA drug product sections
- Strong expertise in chemistry and solid state characterization
- Experience in peptide analytical techniques and aseptic manufacturing
- Direct experience in writing regulatory CMC documents
- Excellent communication and stakeholder management skills
- Ph.D. or master's degree in chemistry or related fields
Aufgaben
- Drive development of peptide parenteral formulations.
- Oversee manufacturing processes for peptide formulations.
- Manage scale-up, process characterization, and validation.
- Facilitate transfer to global commercial manufacturing sites.
- Act as Pharmaceutical Project Leader in CMC teams.
- Shape global regulatory submissions for all phases.
- Impact market approvals for life-changing medicines.
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
Roche
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral 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 - Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Crystallization Specialist / Particle Engineer(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Vollzeitnur vor OrtSeniorBasel