Section Lead Drug Product Process Engineering

About the role

Roche is looking for a Section Lead Drug Product Process Engineering in Basel, Switzerland, within the Department Biologics Pharmaceutical Development. The role leads a team of process engineers developing sterile drug product manufacturing processes for parenteral liquid and lyophilized formulations, from clinical through to commercial stages. It sits in the global Drug Product Process Engineering and Manufacturing team.

Key responsibilities

• Provide technical oversight and strategic guidance for manufacturing process development, including scale-up, process characterization and validation, and transfer to global commercial manufacturing sites.
• Lead, coach and develop a team of about 8-12 process engineers across biologics, synthetic molecules and peptides.
• Ensure process designs for clinical and commercial stages are robust for effective validation and successful commercialization.
• Implement harmonized, science- and risk-based strategies that support efficient technology transfers and process validation with internal and external manufacturing partners.
• Represent the function in stakeholder meetings, emphasizing global harmonization, Lean principles and an innovation mindset.
• Collaborate cross-functionally and with manufacturing sites, including CMOs, to align projects and ensure successful execution.

Required profile

• Ph.D. in a relevant scientific or engineering discipline (preferred) or commensurate experience.
• At least 8 years of relevant experience in the biopharmaceutical industry and proven ability to shape and lead teams.
• Experience leading or managing groups of scientists and engineers and working with departmental senior staff on project and people decisions.
• Strong technical expertise in parenteral process development and readiness to oversee end-to-end pharmaceutical development, including regulatory submissions.
• Able to prioritize resources across the network and sponsor strategic process engineering projects.
• Willingness to travel up to 20% domestically and internationally.