Manufacturing Technology Scientist
This vacancy has now expired
Our client has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Dublin, approximately a $1 billion investment. Once commissioned, the new facility will significantly increase their biologics manufacturing capacity and play a central role in its global manufacturing network.
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Multi Product Cell Culture facility
- Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings
- Strong knowledge of cGMP compliance, corporate, site and 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 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 4 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
- You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments
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