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F.F. Hoffmann-La Roche AG

Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)

Basel
VollzeitVor OrtSenior

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

  • Englischverhandlungssicher
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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