Jobs at Alvotech

Provides technical and engineering support for upstream and downstream drug substance manufacturing. Responsibilities include process optimization, troubleshooting, deviation investigations, root cause analysis, CAPAs, change controls, validation, technology transfers, documentation, data analysis, equipment qualification, audits, and cross-functional collaboration across GMP biologics operations.

Leads cross-functional operational excellence and continuous improvement initiatives, optimizing processes, reducing waste, and improving efficiency, quality, compliance, and scalability. Manages strategic transformation projects, facilitates process mapping and redesign, builds improvement capabilities, coaches stakeholders, and supports GMP compliance, inspection readiness, risk assessments, investigations, and CAPA activities. Uses data-driven problem solving and change leadership to deliver measurable, sustainable business improvements.

Leads product quality complaint investigations from initiation through closure, conducting root cause analysis, assessing product impact, managing CAPAs, and ensuring GMP compliance. Collaborates cross-functionally with manufacturing, suppliers, quality control, engineering, and supply chain teams. Identifies continuous improvement opportunities within the quality management system and manages multiple investigations according to established timelines and regulatory expectations.

Leads upstream process support, scale-up, technology transfer, troubleshooting, deviation investigations, CAPAs, process optimization, and lifecycle management for commercial biosimilar products. Provides technical leadership across GMP manufacturing sites, authors regulatory documentation, supports CPV and process changes, evaluates new materials and technologies, and collaborates with cross-functional teams to ensure compliance and successful project execution.

Executes downstream biopharmaceutical manufacturing activities in cleanroom environments, including chromatography, viral inactivation, filtration, formulation, bulk filling, and freeze storage. Ensures cGMP, EHS, inspection readiness, and documentation compliance; supports validation, investigations, CAPAs, regulatory inspections, and continuous improvement. Serves as a subject matter expert, authors and reviews GMP documentation, and mentors team members while working rotating shifts.

The Senior Upstream Biotechnologist executes and supports cGMP upstream manufacturing, including fermentation, seed train operations, and media preparation. Responsibilities include managing deviations, CAPAs, investigations, process data analysis, troubleshooting, technology transfer, validation, scale-up, GMP documentation, audit readiness, and compliance with EHS standards. The role also mentors team members and requires rotating day, evening, and night shifts in controlled manufacturing environments.

Support and maintain EHS programs for biopharmaceutical manufacturing. Provide guidance to employees, contractors, and vendors on EHS standards; lead audits, inspections, and risk assessments; advise teams on EHS requirements; and drive continuous improvement and compliance initiatives.

Lead and build statistical and data management programming for biosimilar clinical studies. Establish standards, validate code, produce SDTM/ADaM datasets and TLFs, ensure regulatory compliance and inspection readiness, and manage/mentor a programming team while supporting global submissions.

Perform manual visual inspection and packaging of final pharmaceutical products in controlled/non-classified (CNC) areas, document results in computer systems, follow cGMP/EHS/SOPs, support GMP activities and audits, and work shift-based in a dark-room environment.

Support biomanufacturing quality operations by managing deviations, CAPAs, change controls, and quality records; ensure cGMP compliance, perform facility and EHS inspections, contribute to audits and regulatory interactions, and drive continuous improvement in production.