Sobi
Global Regulatory CMC Lead(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
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CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing industrialization roadmaps for peptide parenteral drug product launches at a pharmaceutical company. 6+ years in peptide parenteral formulation/process development with NDA authoring experience required. Focus on cutting-edge peptide research and launch strategies.
Anforderungen
- Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields
- Minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms
- Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products
- Developing and launching peptide combination products for parenteral use
- Deep expertise in chemistry and solid-state characterization
- Experience in peptide analytical techniques and aseptic manufacturing processes
- Experience in scale-up and technology transfers
- Understanding regulatory and quality requirements
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Ability to assess program and submission risks from a drug product formulation and manufacturing perspective
- Excellent communication and collaboration skills
- Strong stakeholder management skills
- Ability to think end-to-end and globally
- Proven team player with a problem-solving mindset
- Passion for innovation in the pharmaceutical field
Aufgaben
- Develop the technical roadmap for industrialization readiness of peptide portfolio
- Advise and coach CMC teams on robust formulation and manufacturing processes
- Manage risks and mitigations for parenteral synthetic molecules portfolio
- Stay updated on advancements in peptide research and formulation science
- Lead scientific strategies and decision-making for development plans
- Mentor staff in preparing and authoring CTA and New Drug Applications
- Collaborate with cross-functional stakeholders to address challenges
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 Roche 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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RORoche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing industrialization roadmaps for peptide parenteral drug product launches at a pharmaceutical company. 6+ years in peptide parenteral formulation/process development with NDA authoring experience required. Focus on cutting-edge peptide research and launch strategies.
Anforderungen
- Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields
- Minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms
- Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products
- Developing and launching peptide combination products for parenteral use
- Deep expertise in chemistry and solid-state characterization
- Experience in peptide analytical techniques and aseptic manufacturing processes
- Experience in scale-up and technology transfers
- Understanding regulatory and quality requirements
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Ability to assess program and submission risks from a drug product formulation and manufacturing perspective
- Excellent communication and collaboration skills
- Strong stakeholder management skills
- Ability to think end-to-end and globally
- Proven team player with a problem-solving mindset
- Passion for innovation in the pharmaceutical field
Aufgaben
- Develop the technical roadmap for industrialization readiness of peptide portfolio
- Advise and coach CMC teams on robust formulation and manufacturing processes
- Manage risks and mitigations for parenteral synthetic molecules portfolio
- Stay updated on advancements in peptide research and formulation science
- Lead scientific strategies and decision-making for development plans
- Mentor staff in preparing and authoring CTA and New Drug Applications
- Collaborate with cross-functional stakeholders to address challenges
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 Roche 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
Roche
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- Sobi
Global Regulatory CMC Lead(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis Pharma AG
Therapeutic Area Strategy Head, CRM(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis Pharma AG
Analytical Expert (Postgraduate Early Talent Program)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis
Site Quality Head(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
External Manufacturing Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel