The Biologics Analytical Research & Development (BARD) department in Dunboyne is seeking applications for a Research Senior Specialist in the Raw Materials team. This role will specialise in ensuring material flows appropriately through the information management systems in use at the site for material control. The role will be tasked with oversight and responsibility of material management in the BARD department. The successful candidate must be self-driven and confident to take ownership of sample management program & be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The Senior Specialist is expected to be a subject matter expert for material management flow and is confident to lead a group of specialists.
Tasks and responsibilities include but are not limited to.
- Ownership of BARD responsibilities for raw materials at the site.
- Lead raw material programs for all new biologics coming to site.
- Ensuring raw material testing proposed is appropriate, GMP, verified, tested, released as per the quality management system.
- Review execution of analytical method validations and transfers (among different sites, and between the Company and CROs) and write technical protocols and reports.
- Collaborate with a global network of scientists to streamline and platform scientific methods entering Dunboyne.
- Propose Raw Material testing and specifications, Generation of Global test specifications, ensuring testing is qualified to GMP either internally or externally.
- Manage relationship with the testing laboratories & partner with Warehouse, supply chain, quality to ensure raw materials are released in accordance with GMP & internal procedures.
- Oversight of the Raw Material Systems Build & Maintenance on Comet & GLIMS.
- Author & oversee Raw Material Related Testing Investigations.
- Analyse and optimize current IT lab System business processes for the laboratories and support implementation activities of the technologies and methodologies.
- Works in accordance with applicable internal company regulations: safety, health, and environmental protection.
- Top of Form.
Your profile:
- M.S in analytical chemistry/biochemistry or related field with 3 years of experience or B. S with a minimum of 7 years of experience in the Pharmaceutical Industry.
- GMP working experience and a working knowledge of regulatory requirements.
- Knowledge of Analytical Methodologies and sound scientific understanding with focus on liquid chromatography and IR spectroscopy as well as data analysis and statistics for setting specifications.
- Effective organizational and multi-tasking skills with strong oral and written communication skills.
- Team player with ability to support peer to peer coaching.
- Author technical protocols and reports as required.
- Understanding of current manufacturing processes.
- Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.
- Expertise in method validations and technology transfers.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
