In this role, you will be responsible for providing technical and scientific support in the production of biological drug products. As a technical operations team member, you will be a specialist in Sterile fill-finish operations and will be responsible for the tech transfer and new product introduction of parental and lyophilization products into the facility and to support the manufacturing process in line with Operations and Quality requirements. You will also be responsible for providing technical and engineering support from a formulation perspective, and to develop new and innovative processes to deliver cost reductions in line with Operations and Quality requirements to support the manufacturing process.
This is a great opportunity for experienced Biologics/Pharma professional.
- To provide scientific and technical support for the aseptic filling and lyophilization of biological drug product.
- Subject Matter Expert (SME) in the aseptic filling process, isolator technology and representation at various regulatory audits.
- Responsible for planning and leadership of technology transfers and new product introduction activities into the facility.
- Understand the drug product process behaviour by evaluating process and technical data, literature, and work closely with S&T organization in the design of experimental strategies.
- Support process investigations, primarily by seeking scientific/technical root causes and liaise with S&T to perform lab-related investigations if required.
- Assist with product impact assessment for change controls and internal/external investigations as required.
- Monitoring and analysis of process data during the manufacturing of drug product.
- Identification and project management of continuous improvement projects. Work closely with other departments to deliver these continuous improvement projects.
- Work closely with the global science and quality teams, on the process development of suitable future products.
- Continuously drive to improve processes for improved performance and cost reduction wherever possible
- Relevant engineering or science degree
- Minimum of 3 years’ experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
- Experience in new product introductions to Biologic facilities is desirable
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
- Experience working with lean methodologies is desirable.
- Previous experience in lyophilization and sterilization operations preferable
For further information on this role please contact Tommy McKeown on 086 0100903 / email@example.com Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
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