Senior Specialist, USP MSAT

Overview of role:

Are you a subject matter expert in upstream processing with a passion for innovation and technical excellence in biologics manufacturing? Alvotech is seeking a USP MSAT Specialist – Late Stage to lead upstream process support, scale-up, and lifecycle management for commercial biosimilar products.

Key Responsibilities:

• Act as the Subject Matter Expert (SME) for upstream manufacturing processes, providing technical leadership and guidance.
• Lead process scale-up and technology transfer from development to GMP manufacturing (clinical and commercial), including defining scale-up strategies and ensuring successful implementation across internal and external sites.
• Provide independent technical support to manufacturing, including process monitoring, troubleshooting, and advanced data analysis to anticipate and resolve issues proactively.
• Investigate manufacturing deviations, perform root cause analysis, and implement effective CAPAs.
• Author, review, and approve process and regulatory documentation, including PDDs, protocols, reports, change controls, and regulatory submissions.
• Support the introduction, qualification, and ongoing optimization of upstream processes in cGMP manufacturing, managing associated technical risks.
• Lead and contribute to process optimization and continuous improvement initiatives, enhancing yield, robustness, and cost-efficiency.
• Support lifecycle management of commercial products, including Continued Process Verification (CPV), process changes, and ongoing process monitoring.
• Assess, qualify, and introduce new materials, technologies, and innovations to improve manufacturing performance and efficiency.
• Collaborate with and represent MSAT in cross-functional and cross-site teams, driving technical solutions, effective communication, and project delivery.
• Ensure compliance with cGMP, regulatory, and EHS requirements in all activities.
• Proactively identify, evaluate, and resolve technical challenges, leveraging expertise and continuous learning to improve processes.
• Contribute to project execution and timelines, influencing technical decisions and ensuring alignment with business objectives.