Overview of role:
Are you passionate about driving process excellence in biopharmaceutical manufacturing? Alvotech is seeking an MSAT Specialist to lead technology transfer, scale-up, and process optimization activities, ensuring seamless transition from development to GMP manufacturing. This role plays a critical part in supporting manufacturing performance, resolving technical challenges, and enabling successful product delivery through strong cross-functional collaboration and technical expertise.
Key Responsibilities:
- Lead and manage projects independently or collaboratively, supporting technology transfer, process performance qualification (PPQ), late-stage continuous process monitoring, and lifecycle management.
- Provide technical leadership by guiding teams through deviation investigations, ensuring effective root cause analysis, and supporting critical decision-making.
- Drive successful transfer of development and manufacturing processes from internal sites to large-scale GMP manufacturing at Alvotech Iceland.
- Develop and author comprehensive scale-up strategies prior to technology transfer for both clinical and commercial manufacturing, across internal and external sites.
- Oversee the introduction and qualification of new processes into cGMP manufacturing, proactively managing technical risks and ensuring effective cross-functional communication for successful technology transfer outcomes.
- Lead investigations into manufacturing deviations, identify root causes, and define appropriate CAPA (Corrective and Preventive Actions).
- Deliver independent on-plant technical support, including process monitoring and advanced data analysis, proactively identifying and mitigating potential risks.
- Represent MSAT in complex internal and external project teams, fostering strong collaboration, effective communication, and timely problem resolution.
- Drive process optimization and continuous improvement initiatives, leading cross-functional teams to implement enhancements aligned with business needs.
- Influence project teams using technical expertise to ensure timely delivery in accordance with business objectives.
- Anticipate, evaluate, and resolve technical challenges within area of expertise proactively.
- Support technology transfer to CMO (Contract Manufacturing Organization) sites by reviewing documentation, identifying gaps, and maintaining a high level of professionalism during interactions.
- Conduct batch reviews and apply continual process learning to resolve gaps and improve unit operations independently.
- Stay informed of advancements in biopharmaceutical manufacturing technologies and evaluate their applicability for process innovation, cost reduction, and yield improvement.
- Mentor and coach new team members, contributing to a highly skilled, engaged, and collaborative DSP team.
- Participate in regulatory review activities and provide timely technical support for product approval processes.
- Support process validation strategies and execution.
- Develop and review SOPs (Standard Operating Procedures) and Process Description Documents (PDDs), ensuring effective transfer of knowledge to execution teams.
- Ensure strict compliance with cGMP and EHS standards, performing all activities safely and in alignment with regulatory and company requirements.
- Demonstrate strong accountability, professionalism, and the ability to take on additional responsibilities with minimal supervision while adhering to company values and conduct standards.
Qualifications:
- Master of Science in Biotechnology or related field.
- Knowledge of data analysis tools such as JMP and Minitab etc
- Minimum 7-9 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.