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- Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D
- Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for our Cork site
- Promote the scientific excellence and innovation in the area and contribute with technical expertise to expand the Intellectual Property, product and technology portfolios.
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Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization...
Performs procurement and sourcing functions which may include, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Develop and execute cost-saving strategies for indirect materials and services.
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Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
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Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering...
- Oversee the execution of the corporate sustainability project, ensuring alignment with the company’s strategic goals;
- Identify and implement opportunities to enhance energy efficiency, reduce resource consumption and minimize environmental impact;
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Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering...
- Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization.
- Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk.
- Prepare, monitor and control the annual departmental budget under responsibility to ensure expenditure is in...
- Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
- Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies.
- Promote the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology...
- As subject matter expert you will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our clients.
- Developing drug product manufacturing processes for oral drug products, including scale up, technology transfer and design space definition.
- Promote innovation by identifying, evaluating, and recommending new technologies and/or methodologies for Hovione.
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