Lead Scientist, Upstream Biological Process

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7elgz7

- Si assicuri di leggere attentamente le informazioni relative a questa possibilità prima di inviare la sua candidatura.
- 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 xivgfpx optimization, scale‐up/do

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7elgz7