Design jobs in Italy

The Senior Research Scientist 2 will play a key role in the formulation development of pharmaceutical products for regulated markets. This position involves hands‑on R&D activities, cross‑functional collaboration, and end‑to‑end project management from literature review to technology transfer.

• Conduct comprehensive literature surveys and patent searches; prepare Prototype Formulation Reports.
• Identify reference products and coordinate procurement activities.
• Develop Quality Target Product Profiles (QTPP) based on literature and reference product characterization.
• Finalize API and excipient sources for new product development.
• Execute pre‑formulation studies and drug–excipient compatibility assessments.
• Drive process optimization and reformulation activities with thorough documentation and closure.
• Prepare regulatory and support CTD documentation for submissions.
• Design and execute pharmaceutical experiments using Quality by Design (QbD) principles.
• Review analytical development data and compile comprehensive product development reports.
• Support batch manufacturing for process optimization, regulatory submissions, and bioequivalence (BE) studies.
• Assist with pilot and scale‑up batches, including documentation and technology transfer to production.
• Develop and maintain R&D SOPs in line with cGMP and GDP standards.
• Submit periodic project reports to management for review and alignment.
• Collaborate with departments including Analytical R&D, Supply Chain, Production, QC, QA, Regulatory Affairs, and Medical Affairs to ensure project timelines are met.
• Handle Technology Transfer Out and Contract Manufacturing for assigned projects.
• Oversee and manage eQMS activities related to R&D.

• Strong result and process orientation with a proactive, responsible approach.
• High level of accountability, ownership, and attention to detail.
• Demonstrated cost-consciousness in R&D operations.
• Effective team collaboration, time, and task management.
• Excellent written and verbal communication in English.
• Highly disciplined, motivated, and organized.

• Master’s degree in Pharmacy (preferred) or Bachelor’s degree in Pharmacy.

• Minimum 8 years of hands‑on experience in Formulation Development for regulated markets.
• Proven experience in addressing regulatory queries for agencies such as US‑FDA, EU, Canada, UAE, Jordan, and KSA.
• Strong background in developing and handling multiple dosage forms, particularly Biosimilars and Injectables.
• Expertise in Technology Transfer and Contract Manufacturing processes.

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