Principal Process Engineer, Pharmaceutical Development

avec compétence (avecco) GmbH; Basel; On-site; CHF 150,000 - 190,000; Full time

Job summary

Try&Hire is seeking a senior specialist to develop manufacturing processes for parenteral liquid and lyophilized formulations in Basel. You will lead process characterization, design studies, and drive technology transfer to global commercial sites while coordinating with cross-functional teams.

You will author drug product sections of NDA/BLA submissions and participate in regulatory preparations for Phase 1-3.

Qualifications

• 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.

Responsibilities

• 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

Skills

Parenteral process development

Technology transfer

Regulatory submissions

Cross-functional collaboration

Process characterization

Travel internationally

Education

PhD or Master’s degree in chemistry, chemical or process engineering, or related field

Job description

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

Your 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

What you bring

• 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

Conditions

• Workload: 100 %
• Work model: On site
• Option of a permanent position after the assignment if both sides want it

What to expect

• 3–6 months interim, then a permanent position