Principal Process Engineer - Parenteral Drug Products

About the role

Roche is looking for a Principal Process Engineer in Pharmaceutical Development, based in Basel, Switzerland. You will join the Department Pharmaceutical Development in Pharma Technical Development (PTD), within the Process Engineering and Manufacturing group. The department develops parenteral drug products from Phase 1 through launch, covering formulation and aseptic manufacturing for synthetic molecules and biologics. The engineer ensures robust clinical and commercial process designs for effective process validation and successful commercialization.

Key responsibilities

• Develop robust manufacturing processes for parenteral liquid and lyophilized formulations, including scale-up, process characterization and validation, and transfer to global commercial manufacturing sites.
• Design and run process characterization and process design studies for parenteral synthetic molecule drug products.
• Act as transfer project leader in global CMC teams and functional representative in cross-functional teams and international committees.
• Collaborate with manufacturing sites and serve as the single point of contact for DP Process Development.
• Author sections of global regulatory submissions for Phase 1-3 and international marketing applications.

Required profile

• Ph.D. or master's degree in chemistry, chemical/process engineering or a related field.
• Minimum 5 years of industry experience in process development for parenteral synthetic molecule dosage forms.
• Proven track record of launching parenteral drug products; combination products experience is a plus.
• Proven experience authoring DP sections of NDAs and/or BLAs for parenterally used molecules.
• Willingness to travel internationally (up to 20%).

Required skills

• Parenteral process development and technology transfers to commercial sites.
• Evaluation of program and submission risk from a drug product and manufacturing standpoint.
• Design and justification of down-scale models, including process parameter definition and characterization.
• Excellent communication, collaboration and stakeholder management skills.