F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Full-timeOn-siteSenior
Basel
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RORoche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Developing and overseeing peptide parenteral formulations from scale-up to global commercial manufacturing at a large pharmaceutical company. Proven experience authoring NDA drug product sections and regulatory CMC documents required. Global project leadership within CMC teams.
Requirements
- Proven experience authoring NDA drug product sections
- Strong expertise in chemistry and solid state characterization
- Experience in peptide analytical techniques and aseptic manufacturing
- Direct experience in writing regulatory CMC documents
- Excellent communication and stakeholder management skills
- Ph.D. or master's degree in chemistry or related fields
Tasks
- Drive development of peptide parenteral formulations.
- Oversee manufacturing processes for peptide formulations.
- Manage scale-up, process characterization, and validation.
- Facilitate transfer to global commercial manufacturing sites.
- Act as Pharmaceutical Project Leader in CMC teams.
- Shape global regulatory submissions for all phases.
- Impact market approvals for life-changing medicines.
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 Roche 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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RORoche
Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Developing and overseeing peptide parenteral formulations from scale-up to global commercial manufacturing at a large pharmaceutical company. Proven experience authoring NDA drug product sections and regulatory CMC documents required. Global project leadership within CMC teams.
Requirements
- Proven experience authoring NDA drug product sections
- Strong expertise in chemistry and solid state characterization
- Experience in peptide analytical techniques and aseptic manufacturing
- Direct experience in writing regulatory CMC documents
- Excellent communication and stakeholder management skills
- Ph.D. or master's degree in chemistry or related fields
Tasks
- Drive development of peptide parenteral formulations.
- Oversee manufacturing processes for peptide formulations.
- Manage scale-up, process characterization, and validation.
- Facilitate transfer to global commercial manufacturing sites.
- Act as Pharmaceutical Project Leader in CMC teams.
- Shape global regulatory submissions for all phases.
- Impact market approvals for life-changing medicines.
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 Roche 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
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- F. Hoffmann-La Roche AG
Senior Scientist, Development (Parenteral Drug Product)(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Section Lead & Center of Excellence (CoE) Strategy Realization(m/w/x)
Full-timeOn-siteManagementBasel - Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Crystallization Specialist / Particle Engineer(m/w/x)
Full-timeOn-siteSeniorBasel - F. Hoffmann-La Roche AG
Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product)(m/w/x)
Full-timeOn-siteSeniorBasel