Overview
Kenny-Whelan (A specialist division of the CPL group) are hiring a Technical Scientist to be based at our clients Biologics facility in Barnahely, Ringaskiddy Cork.
Contact Jenn Dinan on 0860466583 and email [email protected]
Our client has recently expanded its Biologics Operations and manufactures commercial and clinical product with a strong clinical pipeline
It is a fantastic state of the art site to work on, with a campus feel.
Technical Scientist – BioTD API Department
Business Description:
• Reporting to the BioTD API Manager on site this role will support development projects and manufacturing operations at the JSI facility located in Cork, Ireland. Responsible for supporting Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.
Description of the Role:
• Supports early and late phase Technical Transfer activities through generation and execution of protocols/reports, technical writing, participation in manufacturing operations and NPI initiatives.
• Supports “process fit to plant” to provide guidance to both development and manufacturing teams.
• Leads “man in plant” by providing support during manufacturing campaigns for new products or during process validation campaigns.
• Provides expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
• Partner with Project Teams to provide input, review and approval support for BLA submissions
Focus and Scope:
Participate in cross-functional project teams.
Assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
Foster a culture of Lean and Continuous improvement within the department and with internal and external partners
Critical Experiences Required:
• A minimum of a Bachelor’s degree in Engineering, Biology, Pharmacy or related engineering/scientific field is required, advanced degree is preferred.
• Minimum 3 years experience in pharmaceutical or biotechnology industry.
• Biological process development or commercial manufacturing experience, either cell culture and/or purification.
• Excellent communication, skills, both oral and written.
• Capable of planning and executing experiments or projects steps with some supervision.
• Ability to work well in a team environment, strong collaboration skills and flexibility.
• Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.
Critical Competencies:
• Collaboration and Teaming
• Integrity and Credo Based-actions
• Results and Performance Driven
All applications will be treated with the strictest of confidence
Contact Jenn Dinan on 0860466583 and email [email protected]
