Technical Leader Respiratory, Orals & Small Molecules (Process Validation & Life Cycle Management)

TL;DR

Technical Leader Respiratory, Orals & Small Molecules (Pharmaceuticals): Ensuring technical robustness throughout the product lifecycle and delivering compliant industrialization solutions for respiratory and small molecule drugs with an accent on process validation and life cycle management. Focus on designing structured validation approaches, overseeing technology transfers between sites, and implementing modifications to critical components.

Location: Parma, Italy. Hybrid (combining on-site presence with remote work)

Company

hirify.global is an international research-focused biopharmaceutical group specializing in innovative drugs across various therapeutic areas.

What you will do

• Act as the global technical reference for Respiratory, Orals & Small Molecules, ensuring technical robustness throughout the product lifecycle.
• Define and execute industrialization strategies for new products within R&D Product Teams.
• Structure, plan, and coordinate industrial process validation activities to ensure compliant manufacturing processes.
• Lead lifecycle management projects, overseeing technical assessments and modifications to APIs, excipients, devices, and packaging materials.
• Manage technology transfer activities between different group sites and external subcontractors.
• Provide technical and scientific input for qualitative investigations (deviations, OOS, complaints) and audit preparations.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field.
• 10+ years of pharmaceutical/biotech industry experience in drug product manufacturing.
• At least 5 years of experience specifically in the respiratory area (inhalation products).
• Fluency in written and verbal English communication.
• Willingness to travel up to 30% based on project needs.

Nice to have

• Direct experience with DPI or pMDI products.
• Solid experience in Process Validation and Lifecycle Management activities.
• Experience working in multicultural/multinational environments.
• Experience working within a CRO or CMO environment.

Culture & Benefits

• Competitive salary package including performance bonuses and market-benchmarked benefits.
• Comprehensive healthcare programs and work-life balance initiatives.
• Robust relocation support and tax assistance services for foreign colleagues.
• Flexible working arrangements, including remote work options.
• Dynamic and friendly environment with access to continuous resources and training.