Job Title: Process Scientist
We are offering an exciting opportunity for a Process Scientist to join our Therapeutics Development & Supply (TDS) API team in Cork. This role will play a key role in supporting development projects and manufacturing operations, focusing on leading or assisting with Process Development, Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management, and Health Authority Inspections.
Key Strengths You Bring:
- Strong scientific background with experience in biopharmaceutical manufacturing processes.
- Exceptional collaboration and communication abilities, both written and verbal.
- Skilled in root cause analysis, problem-solving, and process optimization.
- A dedicated team player with a customer-focused approach.
As a Process Scientist, your day-to-day responsibilities may include:
- Supporting technical transfer activities during both early and late stages, including generating protocols/reports, technical writing, conducting laboratory scale studies, and participating in manufacturing operations and new product initiatives.
- Contributing to product development activities across both early and late phases, including protocol/report generation, laboratory studies, and participating in Lean Early Development initiatives as needed.
- Providing process fit-to-plant support during early and late development phases, offering guidance to development and manufacturing teams.
- Offering on-site support during manufacturing campaigns for new products or process validation efforts.
- Sharing expertise on manufacturing facility design, scale-up considerations, GMP operations, and supporting development teams.
- Collaborating with project teams to provide input, review, and approval for BLA submissions.
- Participating in cross-functional teams to drive project success.
- Interpreting CMC project plans and timelines, scheduling work, and experiments to ensure alignment with goals.
- Assisting with manufacturing investigations, particularly with non-conformances and CAPAs, to meet product release specifications and timelines.
- Executing experimental protocols to support lifecycle improvements, process validation, technical transfers, and development activities.
- Promoting Lean and Continuous Improvement culture within the department and across teams, both internally and externally.
Key Requirements:
To thrive in this high-performing team, you will need:
- A minimum of a bachelor's degree in biology, Pharmacy, or a related scientific field (advanced degree preferred).
- At least 2 years of experience within a regulated biologics or pharmaceutical industry.
- Experience in biological process development or commercial manufacturing, specifically in cell culture or purification.
- Excellent written and verbal communication skills.
- Ability to plan and execute experiments or project steps with some supervision.
- Strong teamwork and collaboration skills, with adaptability in a dynamic environment.
- Excellent interpersonal skills, with the ability to adjust to shifting project priorities and requirements.
- Keen attention to detail and a focus on customer and patient outcomes always.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
