Our client is a leading global biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and a range of services. Selling in over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. They are currently looking for a Process Scientist to join their Biologics site. This role is within the Manufacturing / Technology Department and reporting into the Manufacturing Senior Manager.

The Position

• Support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products.

• Provide hands-on technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls and preparation of regulatory filings.

• Accountable for delivery of upstream and downstream technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. Assists in evaluating process performance by comparing manufacturing data to historical data.

• Strong knowledge of cGMP compliance, site and regulatory agency requirements and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.

• Participates in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.

The Person

• BSc, MSC, PhD in a relevant discipline (e.g. Biochemistry, Chemistry, Process Engineering) or equivalent experience.

• At least 2 years' relevant experience in bioprocess development and/or manufacturing, specifically on large scale mammalian cell culture / bioreactor systems.

• Knowledge of quality systems (ETS, SAP, Veeva Vault), Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing.

• Not essential but nice to have, knowledge of Statistical Process Control, Computer Modelling, Data Analytics, and related tools.

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To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.