- Collaborate closely with the Material Science group and guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria.
- Collaborate with raw material suppliers within Ireland and Europe to establish effective control strategies based on understanding and importance of raw material in API manufacturing
- Contribute towards developing raw material specifications, e.g., cell culture media, chromatography resins and excipients
- Perform Bill of Materials Assessment for new materials introduced to the site and source alternative vendors and suppliers when needed
- Support Analytical method transfers by coordinating testing with Europe based Analytical labs
- Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
- Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
- Support supplier audits as required
- Identify and coordinate analytical characterisation with the internal and external labs and perform testing as applicable
- Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
- Participate in project and scientific meetings to share information, knowledge, ideas, and judgement to help establish valid scientific directions in product development or investigations
- Ensure compliance with safety, GMP, quality and scientific principles
- Develop subject matter expertise on assigned analytical techniques.
- Independently write/revise SOP’s or other official documentation and technical reports, when required.
- Execute independently assigned projects.
- Train/Coach other personnel.
- A BSc in a Science subject, Materials Science, Chemistry, Engineering or a related field, with at least 9 years of experience or a MSc in in a Science subject, Materials Science, Chemistry, Engineering or a related field with at least 6 years of experience or Ph.D. with at least 2 years of post-doctoral experience is essential
- Proficiency in functional characterisation of cell culture media including cell culture performance evaluation using stationary, shake flask, automated cell culture systems, and/or bioreactors is required
- Demonstrated proficiency in the analytical characterization of cell culture media and materials utilized in upstream processes and downstream processes is preferred
- Experience in qualification of cell culture media and raw materials is strongly preferred
- Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is an advantage
- Demonstrated competency and experience in use of project management and database tools (e.g., MS Project)
- Microsoft office proficiency in Excel, Word, PowerPoint are required
- Experience with lean and/or six sigma methodologies and tools is preferred
- Ability to quickly learn new processes.
- Ability to communicate clearly and to form strong working relationships with colleagues.
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Organised, accurate, have strong documentation skills.
- Passionate about quality and customer service.
- Good communication skills both internally and externally.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4809118 or email email@example.com