Senior Parenteral Process Engineer — Tech Transfer & Launch

avec compétence GmbH; Basel; Sur place; CHF 120 000 - 180 000; Plein temps

Résumé du poste

avec compétence GmbH is seeking a senior professional to develop robust parenteral manufacturing processes and drive technology transfer to global sites. You will contribute to regulatory submissions and collaborate with cross-functional teams across borders.

The role requires a PhD or MSc in a relevant field, 5+ years of industry experience, and willingness to travel up to 20%. A track record in parenteral drug product launches strengthens candidacy.

Qualifications

• PhD or MSc in chemistry, chemical/process engineering, or related field.
• Minimum 5 years of industry experience in drug product process development.
• Expertise in parenteral process development and technology transfer to commercial sites.
• Experience authoring drug product sections of regulatory submissions (NDA/BLA).
• Willingness to travel internationally up to 20 percent.

Responsabilités

• Develop manufacturing processes for parenteral liquid and lyophilized formulations.
• Design and execute process characterization and process design studies.
• Lead technology transfer projects to global commercial manufacturing sites.
• Represent process development in cross-functional and international project teams.
• Collaborate with manufacturing sites to ensure successful project execution.
• Author sections of regulatory submissions for Phase 1-3 and marketing applications.

Connaissances

Parenteral process development

Technology transfer

Regulatory submissions

Cross-functional collaboration

Formation

PhD or MSc in chemistry/chemical/process engineering

Description du poste

avec compétence GmbH is seeking a senior professional to develop robust parenteral manufacturing processes and drive technology transfer to global sites. You will contribute to regulatory submissions and collaborate with cross-functional teams across borders.

The role requires a PhD or MSc in a relevant field, 5+ years of industry experience, and willingness to travel up to 20%. A track record in parenteral drug product launches strengthens candidacy.