- 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 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)

#J-18808-Ljbffr

📌 Lead Scientist, Upstream Biological Process (Parma)
🏢 Jobtailor
📍 Parma