Senior Scientist, Manufacturing - Process Development

Bristol-Myers Squibb; Cruiserath; On-site; EUR 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Scientist for the Cruiserath facility in Ireland to lead downstream unit operations supporting commercial biologics manufacturing. You will guide tech transfers, troubleshoot processes, and interpret lab-scale studies to drive investigations and continuous improvement.

The role requires strong protein purification expertise, GMP knowledge, and the ability to write technical reports and regulatory submissions.

Qualifications

• Degree in chemical or biochemical engineering, biochemistry, biotechnology or a related scientific discipline.
• Bachelor's degree with 7+ years, Master's with 5+ years, or PhD with 2–4 years relevant experience.
• Strong understanding of protein purification, stability and downstream process performance.
• Experience with downstream processing operations and equipment including chromatography and ultrafiltration/diafiltration.

Responsibilities

• Provide technical leadership and SME for downstream unit operations supporting commercial biologics manufacturing.
• Led tech transfer of commercial and pipeline assets to Cruiserath site and wider network with technical oversight and recommendations.
• Lead or support process troubleshooting, root cause analysis, investigations, and CAPA development.
• Design, execute and interpret lab-scale studies supporting investigations, process understanding and tech transfer.
• Author/review study protocols, technical reports, regulatory submissions, and responses to technical enquiries.
• Drive continuous improvement to enhance process robustness, efficiency, compliance and knowledge management.
• Collaborate with MS&T, Manufacturing, Quality, Process Development, Analytical, Regulatory and external partners to align strategy and execution.
• Evaluate emerging downstream technologies and recommend fit-for-purpose improvements.

Skills

Protein purification

GMP knowledge

Technical writing

Stakeholder communication

Process troubleshooting

Education

Bachelor's degree in chemical/biochemical engineering

Master's degree in related field

PhD in relevant discipline

Tools

Chromatography systems

Ultrafiltration

Diafiltration

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Key Responsibilities

• Provide technical leadership and subject matter expertise for downstream unit operations supporting commercial biologics manufacturing.
• Led tech transfer of commercial and pipeline assets to the Cruiserath facility and wider network, providing technical oversight and recommendations.
• Lead or support process troubleshooting, root cause analysis, investigations and the development of scientifically sound corrective and preventive actions.
• Design, execute and interpret laboratory or scale-down studies that support manufacturing investigations, process understanding and technology transfer.
• Author and review study protocols, technical reports, scientific assessments, regulatory submission content and responses to technical enquiries.
• Drive continuous improvement initiatives that enhance process robustness, efficiency, compliance and knowledge management.
• Collaborate across MS&T, Manufacturing, Quality, Process Development, Analytical, Regulatory and external partner organisations to align technical strategy and execution.
• Evaluate emerging downstream technologies and recommend fit-for-purpose improvements where these could strengthen manufacturing performance.
• Mentor and coach scientists and engineers, supporting effective technical decision-making and the development of downstream capability.

Technical Scope

• Protein chromatography
• Viral inactivation
• Viral filtration
• Ultrafiltration and diafiltration
• Membrane and depth filtration
• Primary recovery and centrifugation
• Process-scale and laboratory-scale downstream equipment, including chromatography and filtration systems

Required Qualifications and Experience

• Degree in chemical or biochemical engineering, biochemistry, biotechnology or a related scientific discipline.
• Relevant biopharmaceutical industry experience commensurate with the Senior Scientist level. As an initial benchmark: bachelor's degree with at least 7 years, master's degree with at least 5 years, or PhD with approximately 2 to 4 years of relevant experience.
• Strong scientific understanding of protein purification, protein stability and downstream process performance.
• Demonstrated experience with downstream processing operations and equipment, including chromatography and ultrafiltration/diafiltration systems.
• Experience supporting commercial manufacturing, process development, technology transfer, validation or manufacturing investigations in a regulated environment.
• Ability to independently analyse complex technical issues, integrate multiple data sources and develop clear, evidence-based recommendations.
• Strong technical writing, presentation and stakeholder communication skills.
• Working knowledge of GMP expectations and the potential manufacturing and regulatory impact of technical decisions.

Preferred Qualifications

• Experience with process characterisation, scale-down model qualification or continued process verification.
• Experience leading technical transfer activity and support commercial manufacture
• Experience authoring or contributing to CMC documentation and supporting regulatory inspections or technical responses.
• Demonstrated experience mentoring colleagues or providing technical leadership within cross-functional teams.
• Experience applying structured problem-solving, statistical analysis or design of experiments to bioprocess challenges.

Core Competencies

• Scientific leadership Applies deep technical knowledge and sound judgement to complex downstream challenges.
• Execution Plans and delivers high-quality technical work with appropriate urgency, rigour and documentation.
• Collaboration Builds productive relationships across functions, sites and external partners.
• Communication Conveys technical data, risk and recommendations clearly to scientific and non-scientific audiences.
• Problem-solving Uses structured, evidence-based approaches to identify root causes and sustainable solutions.
• Coaching Shares knowledge, provides constructive guidance and helps build team capability.
• Compliance mindset Understands GMP impact and maintains high standards of data integrity and documentation.
• Continuous improvement Identifies and implements practical opportunities to improve robustness and efficiency.

Working Environment and Role Expectations

- Work is performed through a c