Principal Process Engineer, Parenteral Drug Product

F. Hoffmann-La Roche AG; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

Roche in Basel, Switzerland, invites an experienced Principal Process Engineer to join Pharmaceutical Development within PTD. You will lead parenteral process development from Phase 1 through Launch, focusing on robust manufacturing, scale-up, and transfer to global sites.

You will design process characterization studies, represent DP process development in global CMC teams, collaborate with manufacturing sites, and contribute to regulatory submissions for NDA/BLA.

Qualifications

• Ph.D. or master's degree in chemistry, chemical/process engineering, or related fields.
• Minimum 5 years of professional experience in process development for parenteral dosage forms.
• Expertise in parenteral process development and technology transfers to commercial sites.
• Experience authoring DP sections for NDA/BLA submissions.
• Excellent communication and stakeholder management skills.

Responsibilities

• Develop robust manufacturing processes for parenteral liquid/lyophilized formulations, incl. scale-up and transfer to global sites.
• Design and execute process characterization studies as part of DP development.
• Represent DP Process Development as transfer project leader in global CMC teams.
• Collaborate with manufacturing sites to ensure alignment and successful project execution.
• Author sections in global regulatory submissions for Phase 1–3 and international marketing applications.

Skills

Process development

Regulatory submissions

Cross-functional collaboration

Project leadership

Parenteral manufacturing

Education

Ph.D. or Master in chemistry/chemical/process engineering

Job description

Roche in Basel, Switzerland, invites an experienced Principal Process Engineer to join Pharmaceutical Development within PTD. You will lead parenteral process development from Phase 1 through Launch, focusing on robust manufacturing, scale-up, and transfer to global sites.

You will design process characterization studies, represent DP process development in global CMC teams, collaborate with manufacturing sites, and contribute to regulatory submissions for NDA/BLA.