Upstream Manufacturing Scientist
An Upstream Manufacturing Scientist is required to join a Global biotech company located in Dublin for an initial 12-month contract.
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Essential Duties and Responsibilities for this Upstream Manufacturing Scientist role include, but are not limited to, the following:
- Support process technology transfer, process validation and the preparation of CMC documentation for regulatory filings.
- Investigate and resolve process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
- Assist 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.
- 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.
If you’re interested in the role, please apply now and I will contact you with more details.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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