QC Microbiology Senior Scientist

Overview Of Role

Alvotech is currently seeking a Quality Control senior scientist in the Microbiology Lab to join our Microbiology team in Reykjavik. QC Microbiology senior scientist is responsible for various microbiological testing, ensuring that the testing related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, particularly Good Manufacturing Practices (GMP) to support manufacturing operations and shows thorough understanding of various techniques and microbial processes. Additionally senior scientist supports variosu projects with new product introduction, laboratory investigations and overall improvement projects within the team.

Scope And Responsibility

• Performs routine microbial testing with advanced techniques to support manufacturing during 24/7 operations (shift-based work schedule).
• Execute endotoxin and bioburden testing 
• Plate reading activities 
• Sampling Environmental and Utility monitoring samples
• Execution of method and product verifications 
• Management of identifications, microbial cultures and maintenance
• Performing routine cleaning, verification, reviews, stock checks, and upkeep of laboratory and equipment
• Aseptic practices
• Participate as required in Aseptic Process Simulation Activities
• Support and lead quality events such as CAPAs, Deviations, Change controls and laboratory investigations. 
• Creation of testing protocols and reports 
• Participation and leading in creation and maintenance of quality documents within Alvotech.
• Training of personele 
• Contributes to other documentation reviews and/or updates within the Quality management system, as Subject matter expect.

Job Requirements

• M.Sc in Microbiology and/or other relevant scientific discipline
• 5+ years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology.
• Strong understanding of microbial processes and regulatory compliance
• Good conceptual, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams
• Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset.
• Proficient in using a PC and common Microsoft packages such as Word and Excel.
• Ability to work on a shift-based pattern work schedule

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.