Process Scientist
Life Science Recruitment
- Cork
- Contract
- Full-time
- Leading early and late-phase New Product Introductions and development activities by generating protocols, reports, and executing laboratory scale studies.
- Providing guidance on "process fit to plant" to ensure seamless coordination between development and manufacturing teams.
- Providing support during manufacturing campaigns for new products or process validation campaigns as part of the "man in plant" role.
- Delivering expert insight to development teams regarding manufacturing facility design, capabilities, scale-up considerations, and GMP operations.
- Collaborating with Project Teams to provide input, review, and approval support for BLA submissions.
- Actively participating in cross-functional project teams to foster collaboration and efficiency.
- Interpreting project plans and timelines for CMC projects, scheduling work and experiments to meet project goals.
- Assisting in manufacturing investigations, specifically event, deviation, and CAPA management, to ensure adherence to 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.
- Cultivating 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.