We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• 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.
• 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 plan bs 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.
Education & Experience
• 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