Your new company

Here at Hays we have a fantastic opportunity with our globally renowned biopharmaceutical client based in Dublin, who are actively seeking an experienced Downstream Technology Transfer Engineer to join their team. The client has experienced rapid growth in recent years and boasts a broad product portfolio across a variety of key therapeutic areas such as oncology and immunology. The person will be responsible for process validation and continued process technical support to cell culture and primary recovery unit operations for the commercial manufacture of multiple mammalian cell processes in the facility.

Your new role

• Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction.
• Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles: Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
• To generate documentation protocols and lead the execution of plant-supporting studies and technical studies on the manufacturing floor at a commercial scale
• To provide on-the-floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
• Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies representing the site.
• Document and appropriately communicate aspects of work and learning at internal and external fora (may include participation at scientific meetings)
• Identify or support process improvements (through change control or CAPA) and participate in the implementation of Lean initiatives on site.

What you'll need to succeed

• Minimum of BSc or equivalent with at least 3 years’ experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.

• You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
• Good interpersonal skills coupled with a demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Can effectively partner with and influence stakeholders without direct solid line authority.
• Drives technical decisions balancing product quality and operational requirements

What you'll get in return

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.