QC Microbiology Principal Specialist

Overview Of Role:

Alvotech is hiring a Principal Specialist for its QC Microbiology team. The role ensures compliance with global standards, leads method verification and validation, and supports projects such as new product introductions and facility qualifications. It also involves investigations, CAPAs, and collaboration to integrate microbial controls into manufacturing processes.

Key Responsibilities:

• Support as QC Microbiology SME during regulatory inspections (FDA, EMA, PMDA, etc.) and audits.
• Interpret and implement requirements from USP, Ph. Eur., JP, ICH, and Annex 1 into QC practices.
• Author and review SOPs, protocols, and reports in alignment with current regulatory expectations.
• Provide training and guidance to analysts on regulatory and microbiological topics.
• Design, execute, and review method verification and validation studies for microbiological methods, including.
• Ensure robust documentation, statistical evaluation, and compliance with pharmacopoeial standards.
• Support cross-functional projects including new product introduction, facility qualification, and process validation.
• Provide microbiological expertise in deviation investigations, CAPA development, and change control and support as owner implementation in QC Microbiology
• Participate in risk assessments (FMEA, contamination control risk assessments) to ensure patient safety and product quality.
• Partner with manufacturing and validation teams to ensure microbial controls are integrated into projects.
• Support with testing activities as needed

Qualifications:

• Minimum 4–5 years of experience in QC Microbiology.
• Detailed knowledge and experience of working to cGMP standards within biologics/parenteral manufacturing for aseptically produced drug products.
• Adherence to job description and SOPs relevant to the position, and to company policies and procedures

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.