About this role
Overview of role:
Are you passionate about downstream processing and ready to make a real impact in biopharmaceutical manufacturing? Alvotech is seeking a DSP MSAT Senior Specialist to support the successful transfer, optimization, and performance of biologics manufacturing processes at our state-of-the-art facility in Iceland.
Key Responsibilities:
- Lead downstream process technology transfer and scale-up from development to GMP manufacturing (internal and external sites)
- Develop and execute scale-up strategies for clinical and commercial manufacturing
- Perform gap assessments and facility fit evaluations for external CMOs
- Drive process implementation and qualification into cGMP manufacturing environments
- Provide on-plant technical support, process monitoring, and proactive troubleshooting
- Lead deviation investigations, root cause analysis, and CAPA implementation
- Perform advanced data analysis to ensure process robustness and anticipate risks
- Represent MSAT in cross-functional and external project teams, ensuring alignment and delivery
- Lead process optimization and continuous improvement initiatives
- Influence project teams to ensure timely delivery of technical milestones
- Proactively identify and resolve technical challenges within downstream processes
- Drive continuous process learning and knowledge capture through batch review and data insights
Qualifications:
- Master of Science in Biotechnology or related field.
- Knowledge of data analysis tools such as JMP and Minitab etc
- Minimum 3 years of experience in the biopharmaceutical industry, with a focus on downstream processing (process development, manufacturing, or MSAT).
- Strong expertise in industrial biotechnology and monoclonal antibody manufacturing.
- Solid understanding of GMP environments and regulatory expectations.
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 Alvotech
Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.