Lead Scientist, Upstream Biological Process

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7claq6

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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 (QbD) 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 PhD 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 xysqume optimization, scale?up/down activities, technology transfer, and industrialization of biotechnological products
Solid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines
Experience supporting regulatory submissions and managing manufacturing processes in FDA? and EMA/AIFA?approved facilities
Demonstrated ability to manage CDMO partnerships and external development activities
Strong understanding of product lifecycle management and commercialization strategies for biologics
Good knowledge of English (written and spoken)
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7claq6