Roche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Full-timeOn-siteManagement
Basel
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F.F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading formulation development for injectable drug products, including process scale-up and validation for clinical and launch. 6+ years industry experience with 2+ years in formulation development, BLA/NDA submission experience essential. Work on large-scale development projects for global market access.
Requirements
- Ph.D. or Master’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Chemical/Process Engineering, or related field
- Minimum 6 years professional industry experience
- At least 2 years experience in formulation and process development for parenteral dosage forms
- Proven experience authoring DP sections for BLA and/or NDA submissions
- Excellent communication skills
- Stakeholder management abilities
- End-to-end and global thinking
- Experience in drug delivery systems (strong advantage)
- Experience in associated analytical techniques (strong advantage)
Tasks
- Lead parenteral formulation development for clinical, launch, and line extensions
- Develop robust manufacturing processes for parenteral formulations
- Perform scale-up of manufacturing processes
- Conduct process characterization
- Execute process validation
- Transfer processes to global commercial sites
- Serve as Pharmaceutical Project Leader for global CMC teams
- Represent function in cross-functional teams
- Represent function in international committees
- Author global regulatory submissions for Phases 1-3
- Author market applications (BLA, MAA, NDA)
- Provide critical input for global regulatory submissions
- Provide critical input for market applications (BLA, MAA, NDA)
- Evaluate program and submission risks from drug product standpoint
- Collaborate to transfer products to commercial manufacturing
- Collaborate to transfer processes to commercial manufacturing
Work Experience
- 6 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 Scientist, Development (Parenteral Drug Product)(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading formulation development for injectable drug products, including process scale-up and validation for clinical and launch. 6+ years industry experience with 2+ years in formulation development, BLA/NDA submission experience essential. Work on large-scale development projects for global market access.
Requirements
- Ph.D. or Master’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Chemical/Process Engineering, or related field
- Minimum 6 years professional industry experience
- At least 2 years experience in formulation and process development for parenteral dosage forms
- Proven experience authoring DP sections for BLA and/or NDA submissions
- Excellent communication skills
- Stakeholder management abilities
- End-to-end and global thinking
- Experience in drug delivery systems (strong advantage)
- Experience in associated analytical techniques (strong advantage)
Tasks
- Lead parenteral formulation development for clinical, launch, and line extensions
- Develop robust manufacturing processes for parenteral formulations
- Perform scale-up of manufacturing processes
- Conduct process characterization
- Execute process validation
- Transfer processes to global commercial sites
- Serve as Pharmaceutical Project Leader for global CMC teams
- Represent function in cross-functional teams
- Represent function in international committees
- Author global regulatory submissions for Phases 1-3
- Author market applications (BLA, MAA, NDA)
- Provide critical input for global regulatory submissions
- Provide critical input for market applications (BLA, MAA, NDA)
- Evaluate program and submission risks from drug product standpoint
- Collaborate to transfer products to commercial manufacturing
- Collaborate to transfer processes to commercial manufacturing
Work Experience
- 6 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?
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