Principal Process Engineer, Pharmaceutical Development

avec compétence GmbH; Basel; In loco; CHF 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Parenteral process development

Technology transfer

Regulatory submissions

Cross-functional collaboration

Formazione

PhD or MSc in chemistry/chemical/process engineering

Descrizione del lavoro

The role develops robust manufacturing processes for parenteral drug products, from process characterization to technology transfer and commercial launch.

Tasks

• 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

Profile

• PhD or master's degree in chemistry, chemical or 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 designing and justifying down-scale models and process parameters
• Track record of parenteral drug product launches for synthetic molecules
• Experience authoring drug product sections of regulatory submissions (NDA/BLA)
• Willingness to travel internationally up to 20 percent

Offer

• 3-6 months interim, then a permanent position

Company

Pharmaceutical development