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)

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