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Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Developing robust oral dosage formulations and lean manufacturing processes for new chemical entities, representing department on scientific boards. 5-10 years in oral dosage forms development required. Collaboration with international teams, department representation on scientific boards.
Anforderungen
- PhD or Master’s in Pharmaceutical Technology or Chemical/Process Engineering
- 5–10 years of experience in oral dosage forms development
- Broad expertise in drug product lifecycle
- Authorship of CMC regulatory dossiers
- Preference for direct interaction with health authorities
- Excellence in managing external partnerships
- Strong ability to lead and collaborate with CDMOs
- Results-driven innovator
- Out-of-the-box thinking for technical solutions
- High adaptability to organizational change
- Coaching mindset
- Excellent communication skills
- Fair team player
- Ability to work independently and cross-functionally
- High degree of professional flexibility
- Willingness to travel occasionally
Aufgaben
- Develop robust oral dosage formulations for new chemical entities
- Develop lean manufacturing processes for new chemical entities
- Collaborate with international teams
- Represent the department on technical development teams
- Represent the department on scientific boards
- Drive scientific initiatives
- Develop clinical oral solid drug product formulations
- Optimize clinical oral solid drug product formulations
- Develop commercial oral solid drug product formulations
- Optimize commercial oral solid drug product formulations
- Develop manufacturing processes for oral solid drug products
- Optimize manufacturing processes for oral solid drug products
- Scale up manufacturing processes
- Transfer processes to commercial manufacturing sites
- Facilitate process validation at manufacturing sites
- Develop new drug delivery technologies
- Implement innovative drug delivery technologies
- Apply statistical tools (e.g., DoEs)
- Apply risk assessment tools for QbD (e.g., QRA, FMEA)
- Apply modeling and simulation tools
- Review scientific literature regularly
- Integrate innovative concepts and technologies into scientific strategy
- Participate in Roche scientific teams
- Participate in external scientific consortia
- Author and review technical reports
- Author and review manufacturing instructions
- Author and review process validation documents
- Author and review CMC parts of regulatory submissions
- Contribute to intellectual property protection
- Share knowledge and experience with scientists
- Act as a project consultant
- Act as a mentor
Berufserfahrung
- 5 - 10 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 / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Developing robust oral dosage formulations and lean manufacturing processes for new chemical entities, representing department on scientific boards. 5-10 years in oral dosage forms development required. Collaboration with international teams, department representation on scientific boards.
Anforderungen
- PhD or Master’s in Pharmaceutical Technology or Chemical/Process Engineering
- 5–10 years of experience in oral dosage forms development
- Broad expertise in drug product lifecycle
- Authorship of CMC regulatory dossiers
- Preference for direct interaction with health authorities
- Excellence in managing external partnerships
- Strong ability to lead and collaborate with CDMOs
- Results-driven innovator
- Out-of-the-box thinking for technical solutions
- High adaptability to organizational change
- Coaching mindset
- Excellent communication skills
- Fair team player
- Ability to work independently and cross-functionally
- High degree of professional flexibility
- Willingness to travel occasionally
Aufgaben
- Develop robust oral dosage formulations for new chemical entities
- Develop lean manufacturing processes for new chemical entities
- Collaborate with international teams
- Represent the department on technical development teams
- Represent the department on scientific boards
- Drive scientific initiatives
- Develop clinical oral solid drug product formulations
- Optimize clinical oral solid drug product formulations
- Develop commercial oral solid drug product formulations
- Optimize commercial oral solid drug product formulations
- Develop manufacturing processes for oral solid drug products
- Optimize manufacturing processes for oral solid drug products
- Scale up manufacturing processes
- Transfer processes to commercial manufacturing sites
- Facilitate process validation at manufacturing sites
- Develop new drug delivery technologies
- Implement innovative drug delivery technologies
- Apply statistical tools (e.g., DoEs)
- Apply risk assessment tools for QbD (e.g., QRA, FMEA)
- Apply modeling and simulation tools
- Review scientific literature regularly
- Integrate innovative concepts and technologies into scientific strategy
- Participate in Roche scientific teams
- Participate in external scientific consortia
- Author and review technical reports
- Author and review manufacturing instructions
- Author and review process validation documents
- Author and review CMC parts of regulatory submissions
- Contribute to intellectual property protection
- Share knowledge and experience with scientists
- Act as a project consultant
- Act as a mentor
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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?
- F. Hoffmann-La Roche AG
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Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Vollzeitnur vor OrtManagementBasel - Idorsia
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