Lead Scientist, Upstream Biological Process

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77zvs6

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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

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- 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/77zvs6