Job Purpose:
We have an exciting opportunity for a Technical Scientist to join our Biotherapeutics Development & Supply (BTDS) API team in Cork. This role will support development projects and manufacturing operations at JSI and be responsible for leading or supporting Process Development, Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.
What you’re great at:
• Strong scientific background including experience of Biopharmaceutical manufacturing processes.
• Excellent collaboration & communication skills, both written and oral.
• Experience of root cause problem solving and process optimization skills.
• Excellent team player with strong customer focus.
As an Technical Scientist your typical day may include:
• Supporting early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
• Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
• Supporting “process fit to plant” during early and late stages of development to provide guidance to both development and manufacturing teams.
• Supporting “man in plant” by providing support during manufacturing campaigns for new products or during process validation campaigns.
• Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
• Partnering with Project Teams to provide input, review and approval support for BLA submissions.
• Participating in cross-functional project teams.
• Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
• Assisting in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
• Executing experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
• Fostering a culture of Lean and Continuous improvement within the department and with internal and external partners.
Be vital:
To be part of this high performing team you will have:
• A minimum of a Bachelor's degree in Biology, Pharmacy or related scientific field is required, advanced degree is preferred.
• 2+ years’ experience within a regulated biologics or pharma 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.
• Acute attention to detail
• A focus on patients and customers at all times
