Expert In Drug Product Formulation And Processing For Synthetic Molecule Parenterals (cmc Advisor)
Roche
Basel, Switzerland
Formulation and process development for peptide parenterals
Authoring drug product sections of ndas
Solid-state characterization expertise
The role involves developing technical roadmaps to ensure industrialization readiness for the peptide portfolio through strategic global collaboration
Job Summary
The role involves developing technical roadmaps to ensure industrialization readiness for the peptide portfolio through strategic global collaboration.
Candidates will advise and coach CMC teams to manage risks and mitigate issues for the parenteral drug product synthetic molecule portfolio.
Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent, stop, and cure diseases.
Matching Summary
The role involves developing technical roadmaps to ensure industrialization readiness for the peptide portfolio through strategic global collaboration.
Skills & Requirements
Must-have
Formulation and process development for peptide parenterals
Authoring Drug Product sections of NDAs
Solid-state characterization expertise
Aseptic manufacturing processes experience
Technology transfer and scale-up knowledge
Regulatory CMC submission document writing
Nice-to-have
Strategic vision for industrialization readiness
Mentoring staff on regulatory submissions
Cross-functional stakeholder collaboration
Problem-solving mindset in R&D
Passion for pharmaceutical innovation
Key Requirements
Ph.D. or Master's degree in chemistry or chemical engineering
Minimum 6 years industry experience in peptide formulation
Proven track record authoring NDA Drug Product sections
Direct experience with regulatory CMC source documents
Work Rights
Willing to relocate to Basel; office presence required 3 days/week