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The Scientist role is responsible for execution of projects at Hovione Technology Transfer (TTC) to achieve clients’ expectations and Hovione objectives and in compliance with all Federal, State and Local requirements, namely:  EPA, OSHA and FDA, and with all Hovione internal policies. This role will aaccomplish project timelines, product quality, required quantities and project budget to guarantee that all steps are carried out according to cGMP rules.

Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - To assist analytical chemists in analytical...

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Apply and develop knowledge of Quality Control and participate in area processes,...

- 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,...

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Apply and develop knowledge of Quality Control and participate in area processes,...

Promotes and sells a portfolio of products and/or services and solutions directly to current and new end customers. Informs customers of new product/service introduction and prices. Creates, monitors and revises lead generation plans to ensure a substantive sales opportunity pipeline. Negotiates, with autonomy, highly complex contracts.   - Achieve and deliver personal sales targets, maximizing profitability of new business - Prospect for new...

- Contribute to the development of the Operational Excellence Roadmap to deliver the long term needs of the organisation by leading the establishment systems such as: - Tiered Performance Management in production and supporting functions. -

To be responsible for the management of Process and/or Production works/projects assigned to the role on site. Active participation on new projects, technical transfers from other sites, development in scale up and process improvements to established processes.   Responsibilities:   -

- Lead the development and implementation of the area R&D strategy including alignment with the area objectives and Global R&D - Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for the area - Promote the scientific excellence and innovation in the area and contribute with technical expertise to expand the Intellectual Property, product and technology portfolios. -

- Lead a cross functional team responsible for managing the innovation processes and the internal R&D projects - Manage resources allocation and assign team members responsibilities for specific tasks, (re)prioritizing to make the best use of internal and external resources -

- 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. -

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...

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.   -

Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.   -

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...

- Provide scientific leadership and act as a subject matter expert in analytical development to support R&D process development and other relevant areas. - Collaborate effectively with internal and external stakeholders to optimize experimental design, troubleshoot technical challenges, perform sample analysis, interpret data, generate reports, and communicate results promptly to key project stakeholders. - Recommend and oversee the analytical characterization package (chemical, physical, performance) while ensuring the quality and...

- 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. -