F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Full-timeOn-siteSenior
Basel
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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
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Not a perfect match?
- F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
Section Lead Particle Design(m/w/x)
Full-timeOn-siteSeniorBasel - Idorsia
Associate Director, Technical Project Leader Drug Product(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Crystallization Specialist / Particle Engineer(m/w/x)
Full-timeOn-siteSeniorBasel