Senior Specialist, Quality Control - Analytical Methods

About the role

The Quality Control department at Alvotech is looking for a dedicated Senior Specialist with extensive experience in analytical method technology transfers, CAPA management, Health Authority responses, analytical investigations and scientific oversight. The role acts as the analytical subject matter expert for product testing methods and leads method transfers between Alvotech and contract manufacturing organisations (CMOs).

Key responsibilities

• Lead analytical technology transfer activities between Alvotech and CMOs, ensuring successful method implementation and lifecycle management of analytical methods.
• Act as the analytical subject matter expert for product testing methods, including chromatography, electrophoresis, compendial and biochemical techniques.
• Coordinate transfer activities, troubleshoot technical challenges and drive timely resolution of method-related issues.
• Author and review transfer protocols, reports and validations; author, review and approve CAPAs, change controls, document change controls, deviation investigation actions and associated quality documentation.
• Lead and support investigations into analytical quality events such as invalid assays, OOS, OOT and OOE results.
• Prepare responses and scientific justifications for regulatory and Health Authority inquiries.
• Collaborate with ARD, Regulatory Affairs, Manufacturing, MSAT and Quality Assurance teams to support product lifecycle management.
• Drive continuous improvement to improve laboratory compliance, efficiency and effectiveness, ensure cGMP compliance, and train other scientists in analytical methods.

Required profile

• Bachelor's or master's degree in a technical discipline such as pharmacy, biotechnology, biochemistry or a related field.
• 5-10 years of experience in the pharmaceutical or biopharmaceutical industry.
• Proven experience in analytical method technology transfer and product lifecycle management.
• Strong experience managing CAPAs, change controls, deviations and complex analytical investigations.
• Experience supporting regulatory submissions and responding to Health Authority queries.
• Expert knowledge of methods, techniques and relevant procedures, and open to flexible working hours.

Required skills

• Analytical method technology transfer and validation
• CAPA, change control and deviation investigation management
• Chromatography, electrophoresis and biochemical techniques
• Excellent written and verbal communication skills

What we offer

• A global, fast-growing company with an international, inclusive work culture.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• In-house canteen and coffee house, exercise and wellbeing support for full-time employees.
• On-site shower facility, transportation grant and internet at home for full-time employees.