Head of Manufacturing Science

4 ore fa

Rome, Italia Arethusa A tempo pieno

**RIF. 3050: HEAD OF MANUFACTURING SCIENCE & TECNOLOGY **- from Pharmaceutical business**

**Responsibility**:The main responsibilities of this position are to ensure new product introduction, scale up industrial level, technology transfer (IN & OUT), adequate process validation is in place and technical & scientific support to commercial production as a center of competence in manufacturing Science.

In particular:

- Act as interface for R&D in terms of know how collected for new products under development or Life Cycle Management
- Ensure finalization of the new products introduction (since Clinical phase II), including process scale-up, validation and package for regulatory submission
- Perform product process robustness and capability analysis, proposing improvements and timelines for their implementation
- Guarantee the mid-long term planning and execution of the possible plant and equipment implementation for the industrialization of the new products
- Manage all the technology transfer activities in order to perform insourcing and outsourcing of products and transferring of products among different CMOs
- Manage changes of the critical components of the products (e.g. API, excipients, CCS, primary packaging) and manufacturing processes (e.g. batch size increase, process optimization, change of critical equipments) due to external factors (e.g. suppliers, cost reductions or business continuity)
- Ensure a robust manufacturing process is in place, routinely monitored in their performances and continuously improved.
- Guarantee the process knowledge of the products throughout the commercial lifecycle, maintaining the oversight on the process capability (state of validation) through data trending and statistical analysis of critical parameters, ensuring that processes are robust and continuously improved
- Assess and plan together with local QA validation/re-validation/verification/periodic monitoring/ batches consulting approving and reviewing the process validation Master Plan.
- Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area

**Technical & soft skills**:

- Technical or Scientific Degree
- Fluent both written and spoken English
- Specific Scale up and Technology Transfer competencies
- Knwoledge and Experience in validation of pharmaceutical production processes in various dosage forms (OSD, Oral Liquid, Sterile)
- GMP standards knowledge and experience is a must.

**Location**:L’ Aquila

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