Senior Specialist, Manufacturing Operations

About the role

Alvotech is seeking a Senior Specialist in Manufacturing Operations to ensure GMP compliance, drive investigations, and support continuous improvement across its biopharmaceutical production sites. The role works closely with cross‑functional teams to maintain inspection readiness and operational excellence.

Key responsibilities

• Lead and manage investigations, CAPAs, effectiveness checks and change controls, meeting KPI deadlines.
• Provide expertise for Environmental Monitoring excursions and collaborate with QC Microbiology and Sterility Assurance teams.
• Prepare Cell Bank Stability Plans and annual reports, and conduct audit‑trail reviews of manufacturing systems.
• Offer technical oversight during manufacturing, troubleshoot issues, and review quality documentation.
• Deliver GMP and GDP training, maintain SOPs, and keep operational procedures up to date.
• Develop and analyse quality metrics, identify trends, and support risk‑mitigation strategies.
• Maintain inspection readiness of suites and equipment, and participate in risk assessments and root‑cause analyses.

Required profile

• Bachelor’s or master’s degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field.
• Minimum 5 years of experience in downstream manufacturing within a GMP environment.
• Strong understanding of GMP requirements and regulatory compliance.
• Excellent written and verbal communication in English.
• Highly organized with strong attention to detail.

Required skills

• Good Manufacturing Practice (GMP) compliance
• Good Distribution Practice (GDP) awareness
• Corrective and Preventive Action (CAPA) management
• Environmental Monitoring (EM) procedures
• Cell Bank Stability planning and reporting
• Audit‑trail review of manufacturing systems
• Risk assessment and root‑cause analysis

What we offer

• Opportunity to work on impactful projects that improve patient lives.
• Collaborative, international work culture with diverse teams.
• Potential for professional growth within a fast‑growing global company.