Introduzione

I vostri compiti

We are currently seeking candidates to join our Development laboratory in the role of R&D Process Development Chemist with a focus on a Quality by Design approach for the processes. The position will involve designing, implementing, and maintaining QbD principles across the development and manufacturing processes. This role involves close collaboration with various departments to ensure the highest standards of quality and compliance are met; you will undertake key activities during the development and production process of APIs.

Role and Responsibilities:    

• develop and implement QbD principles and practices, including business processes, procedures, and templates, in collaboration with department heads across different functions;
• lead the creation and maintenance of quality risk management documents and process understanding;
• attend and actively participate in meetings of the international QbD champion team;
• work with local QA and other departments to translate corporate QbD standards into local SOPs and working procedures;
• provide support and advice to project teams on QbD and risk management issues;
• train personnel in QbD principles, scientific thinking, risk management, and GMP aspects;
• assist and train colleagues in Design of Experiments (DoE) methodologies;
• pioneer and support the implementation of a science-driven and QRM-driven mindset in product development;
• continuously work on improving and advancing the company's mindset and expertise in applying QbD-driven development;
• establish and maintain templates in the risk management software;
• ensure all QbD documentation is complete, accurate, and compliant with regulatory standards.

Il tuo profilo

Requirements

• Master’s degree in Chemistry, Industrial Chemistry, Chemical Engineering, PhD is preferred
• Strong knowledge of Process Chemistry and aspects related to the plant scale up and Tech Transfer
• At least 5 years of experience in process development of GMP products in the pharmaceutical industry, with a focus on API manufacturing and quality assurance.
• In-depth knowledge of Quality by Design (QbD) principles and practices and Design of Experiments (DoE)
• Strong understanding of regulatory requirements (e.g., FDA, EMA) and GMP guidelines.
• Experience with risk management tools and methodologies (e.g., FMEA, DoE).
• Proficient with IT tools
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively in a cross-functional team environment.
• Languages: Native Italian and proficient in spoken English (already used daily with international counterparts)