Biosimilar developer scaling manufacturing and regulatory infrastructure
Alvotech develops biosimilar therapeutics at manufacturing scale, with active infrastructure modernization across quality, safety, and regulatory systems. The hiring velocity is accelerating with research roles (28 open positions) dominating the pipeline, paired with targeted builds in data (7), manufacturing (7), and engineering (4)—a mix that signals concurrent pushes toward both development throughput and operational compliance. The project list (validation protocols, bioanalytical lab setup, safety data management, media fill simulations, technology transfer) and pain-point concentration (CGMP compliance, inspection readiness, regulatory audit) indicate a company scaling from early-stage R&D toward GMP-certified production and regulatory submission.
Notable leadership hires: Scientific Director
Alvotech is a public biotechnology company headquartered in Reykjavik that develops and manufactures biosimilar drugs—lower-cost versions of originator biologics. Founded in 2013, the company employs 501–1,000 people across R&D, manufacturing, and support functions. The technical foundation runs on established pharma-industry platforms (Veeva suite for regulatory and safety data management, SAP for operations, LIMS and analytical instruments like HPLC/UPLC for lab work, Medidata Rave for clinical data). Current operational focus spans technology transfer from development to manufacturing, bioanalytical laboratory buildout, validation and media fill execution, and construction of formal safety and quality lifecycle systems—work typical of companies transitioning from preclinical/clinical stages toward commercial manufacturing and regulatory submission. Hiring is distributed across Iceland, Sweden, and India.
Alvotech uses Veeva (Vault, EDC, CTMS, Safety), SAP, LIMS, Medidata Rave, CDISC standards, analytical instruments (HPLC, UPLC), CMMS, JMP, and Microsoft Office. The stack is pharmaceutical-industry standard, optimized for regulatory data and GMP compliance.
Alvotech is headquartered in Reykjavik, Iceland. The company is public and was founded in 2013.
Other companies in the same industry, closest in size