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.
  

Qualifications:

• Master’s degree in Life Sciences (Biotechnology or related field).
• 5–10 years of experience in the biopharmaceutical industry, with a focus on upstream processing, process development, manufacturing, or MSAT.
• Strong knowledge of monoclonal antibody manufacturing and industrial biotechnology.
• Experience in GMP environments and regulatory compliance.
• Proven ability to work independently, manage complex technical challenges, and lead cross-functional teams.
  

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and wellbeing support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.

Internet at home for full-time employees.

About Us

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars.

We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business.

Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [email protected]