This global Biopharma company is committed to a single mission to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, and fibrosis. This organisation hires the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration, and personal development. At the organisations Dublin Campus, this organisation supplies Multi-Product Cell Culture Biologics manufacturing producing multiple therapies for the company's growing biologics portfolio. Due to continued expansion at the site, an exciting opportunity has arisen for an experienced MS&T/Technical Operations Scientist to join the organisations growing MS&T Team with an emphasis on providing Technical Support to the sites Downstream Manufacturing Processes:
- Supports new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Biologics facility.
- Supports cross functional project teams to deliver new product introductions in line with program schedules.
- Investigation and resolution of process deviations, root cause investigations and associated impact assessments, CAPAs, process improvements, change controls and preparation of regulatory filings.
- Strong knowledge of cGMP compliance, and awareness of regulatory agency requirements.
- Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
- Authoring of technical documents, including protocols, reports, risk assessments and SOPs supporting the validation of the manufacturing process.
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the site.
- Minimum BSc or equivalent with at least 2+ years' experience in cell culture or purification manufacturing technical support in the biopharmaceutical industry including experience with process validation.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
To learn more about this role apply online or contact Pádraig Ó Luasa on + 353 87 428 0873 for a confidential discussion.