20 set - Italia
Jobtailor
Providing hands‐on scientific and technical leadership in process insourcing, technology transfer, scale‐up, and validation activities Coordinating upstream process development, optimization, and industrialization activities with internal R&D; teams and external CMOs Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability Assessing and interpreting complex scientific data to support decision‐making, risk mitigation, resource allocation, and program strategy Applying and promoting Quality by Design (Qb D) principles and contributing to process characterization, control strategies, and validation plans Supporting regulatory submissions (MAA, NDA, BLA, JNDA) Designing, executing, and evaluating pilot‐scale studies to support process development, optimization, scale‐up, and technology transfer activities Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ),
and commercial process implementation Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports Delivering theoretical and practical training to Manufacturing personnel Requirements MSc or Ph D in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline At least 10 years of experience in biopharmaceutical drug substance process development Strong scientific background in biologics manufacturing and bioprocess development Deep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single‐use bioreactors, centrifugation, and depth filtration Proven experience in process optimization, scale‐up/down activities, technology transfer, and industrialization of biotechnological products Solid knowledge of GMP requirements and global regulatory frameworks, i
20 set - Solofra
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