Drug Product Scientist | Sligo | Permane
COLLINS MCNICHOLAS RECRUITMENT
SLIGO
Our Client is currently looking for a Drug Product Scientist to join their expanding Technical Operations team . In this role, you will be responsible for providing technical and scientific support in the production of biological drug products. You will be a specialist in Lyophilization unit operation 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. Key Responsibilities. To provide scientific and technical support for the aseptic filling and lyophilization of biological drug product. Subject Matter Expert (SME) in Lyophilisation and aseptic filling process and representation at various regulatory audits. Responsible for planning and leadership of technical transfers and new product introduction activities into the facility. Understand the drug product process behaviour by evaluating the process and technical data, literature, and work closely with S&T organisation 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. Requirements. Minimum degree qualification in a relevant science, engineering, or technical discipline. Master’s degree desirable. A background in aseptic processing, drug product development and lyophilization is required. 5 years’ experience in pharmaceutical process science, with experience in aseptic filling, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry. Experience in new product introductions into 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. For a confidential discussion and more information on the role, please contact Davin Ferguson . davin.ferguson@collinsmcnicholas.ie. 071-9140251. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.
1599 days ago