Upstream Biological Process, Lead Scientist
Pubblicato il 04-08-2026 - Experteer Italy in Parma
ph3Experteer Overview /h3pAs a senior leader in Global TechOpS, you will drive the industrialization and lifecycle management of upstream biopharmaceutical processes. You will lead insourcing, technology transfer, scale‑up and validation to ensure robust, scalable manufacturing from development to commercial production. You’ll coordinate across RD, CDMOs, Production, Quality and Engineering, applying QbD principles to meet global regulatory expectations. Your expertise will help shape biologics programs and enable continuous improvement in a dynamic, global setting. /ph3Retribuzione / Benefits /h3ulliProvide hands‑on scientific and technical leadership in insourcing, transfer, scale‑up and validation of biopharmaceutical processes. /liliCoordinate upstream process development, optimization and industrialization with internal RD and external CMOs. /liliLead lifecycle management for commercial biotech processes, ensuring improvement, robustness, compliance and supply reliability. /liliInterpret complex data to support decisions, risk mitigation, resources, and program strategy. /liliApply QbD principles and contribute to process characterization, control strategies and validation plans. /liliSupport regulatory submissions and represent CMC topics with health authorities. /liliDesign, execute and evaluate pilot‑scale studies to support development and transfer activities. /liliCollaborate with Production, Quality, Engineering and Maintenance for feasibility studies, validation campaigns and commercial implementation.
/liliSupport GMP documentation development (batch records, risk assessments, validation protocols, reports). /liliProvide technical expertise for investigations, deviations, changes controls and CAPAs. /liliDeliver training to Manufacturing personnel for compliant production processes. /li /ulh3Responsabilità /h3ulliMSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry or related discipline /liliAt least 10 years in biopharmaceutical drug substance process development with leadership in complex biologics CMC programs /liliStrong background in biologics manufacturing and bioprocess development /liliDeep expertise in upstream process development and manufacturing (including mammalian cell culture, single‑use bioreactors, centrifugation, depth filtration) /liliExperience in process optimization, scale‑up/down, technology transfer and industrialization /liliSolid knowledge of GMP and global regulatory frameworks (FDA, EMA, ICH, CMC) /liliExperience supporting regulatory submissions and managing manufacturing in FDA‑ and EMA/AIFA‑approved facilities /liliDemonstrated ability to manage CDMO partnerships /liliUnderstanding of lifecycle management and commercialization strategies for biologics /liliEnglish proficiency (written and spoken) /li /ulh3Requisiti fondamentali /h3ulliannual performance premio /lilipension /liliprivate medical insurance /liliwellbeing programme /liliflexible benefits programme /lilirelocation support /li /ul /p #J-18808-Ljbffr