Lead Scientist, Upstream Biological Process

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/790uav

pul liProviding hands‑on scientific and technical leadership in process insourcing, technology transfer, scale‑up, and validation activities /li liCoordinating upstream process development, optimization, and industrialization activities with internal RD teams and external CMOs /li liLeading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability /li liAssessing and interpreting complex scientific data to support decision‑making, risk mitigation, resource allocation, and program strategy /li liApplying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans /li liSupporting regulatory submissions (MAA, NDA, BLA, JNDA) /li liDesigning, executing, and evaluating pilot‑scale studies to support process development, optimization, scale‑up, and technology transfer activities /li liCollaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation /li liSupporting the development of GMP documentation, including batch records, risk assessments, validation protocols,



and technical reports /li liDelivering theoretical and practical training to Manufacturing personnel /li /ul h3Requirements /h3 ul liMSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline /li liAt least 10 years of experience in biopharmaceutical drug substance process development /li liStrong scientific background in biologics manufacturing and bioprocess development /li liDeep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single‑use bioreactors, centrifugation, and depth filtration /li liProven experience in process optimization, scale‑up/down activities, technology transfer, and industrialization of biotechnological products /li liSolid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines /li liExperience supporting regulatory submissions and managing manufacturing processes in FDA‑ and EMA/AIFA‑approved facilities /li liDemonstrated ability to manage CDMO partnerships and external development activities /li liStrong understanding of product lifecycle management and commercialization strategies for biologics /li liGood knowledge of English (written and spoken) /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/790uav