USP MSAT Senior Specialist

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.
• Investigate complex upstream deviations, perform root cause analysis, and implement CAPAs.
• Author and review process documentation including Process Description Documents (PDDs), protocols, reports, change controls, and regulatory filings.
• Provide independent technical support on the manufacturing floor, monitor processes, and analyze data to anticipate and resolve issues.
• Lead process scale-up and technology transfer from small-scale to GMP manufacturing across clinical and commercial stages.
• Assess and qualify new materials and alternate raw materials for upstream processes.
• Support the introduction and qualification of new processes into GMP manufacturing, managing technical risks and leading cross-functional teams.
• Contribute to lifecycle management of commercial biosimilars, including Continued Process Verification (CPV) and process changes.
• Represent MSAT in internal and external project teams, driving technical solutions and ensuring successful outcomes.
• Stay current with biopharmaceutical manufacturing technologies and introduce innovations to improve yield, cost-efficiency, and process robustness.
• Support regulatory submissions and product approval processes.
• Ensure all activities are conducted in compliance with cGMP and EHS standards.

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.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.