Principal Specialist – DSP MSAT (Biopharma)

About the role

Alvotech is looking for a Principal Specialist in Digital and Scale‑up Process (DSP) Manufacturing Science and Technology (MSAT) to lead technology transfer, scale‑up and process optimisation from development through to GMP manufacturing. The role supports manufacturing performance, resolves technical challenges and ensures successful product delivery through strong cross‑functional collaboration.

Key responsibilities

• Lead and manage technology transfer, process performance qualification (PPQ) and lifecycle management projects.
• Provide technical leadership for deviation investigations, root‑cause analysis and CAPA implementation.
• Develop and author scale‑up strategies for clinical and commercial manufacturing across internal and external sites.
• Oversee introduction and qualification of new processes into cGMP manufacturing, managing technical risks.
• Deliver on‑plant technical support, including process monitoring and advanced data analysis.
• Represent MSAT in internal and external project teams, fostering collaboration and timely problem resolution.
• Drive continuous improvement initiatives and influence project delivery aligned with business objectives.
• Support technology transfer to CMO sites, reviewing documentation and identifying gaps.
• Conduct batch reviews, apply continual process learning and mentor new team members.

Required profile

• Proven ability to lead technology transfer and scale‑up projects in a biopharmaceutical environment.
• Experience investigating manufacturing deviations and implementing corrective and preventive actions.
• Strong analytical mindset with capability to perform advanced data analysis for risk mitigation.
• Effective communication skills to collaborate across cross‑functional teams.

Required skills

• cGMP manufacturing knowledge
• Process scale‑up expertise
• Technology transfer methodology
• Process performance qualification (PPQ)
• Deviation investigation and root‑cause analysis
• CAPA development and implementation
• Process monitoring and advanced data analysis
• SOP development and review