Analytical Scientist – LCM & Process Quality Expert

Sanofi; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

Sanofi in Waterford, Ireland is seeking an Analytical Scientist on a 23-month fixed-term contract. You will drive analytical development and Life Cycle Management projects, collaborating with MSAT, Quality, Operations, Validation and Regulatory to ensure robust processes and product quality attributes.

You will lead analytical transfer projects, support process parameter optimization, and provide technical troubleshooting in GMP environments, with hands-on development and collaborative

Qualifications

• Degree in Biologics or Chemistry (NFQ Level 7 or 8) or a related scientific discipline.
• Knowledge of lyophilisation (Lyo) and mAbs sterile fill/finish context.
• Experience leading analytical development projects (research, design, implementation, and transfer/qualification/validation).
• Experience developing and implementing analytical control strategies.
• Experience leading analytical qualification and validation activities.
• Experience providing technical support, troubleshooting and investigation to support manufacturing and GMP activities.
• Subject Matter Expert (SME) in analytical quality attributes and critical process parameters.
• Experience leading analytical transfer projects.
• Experience supporting experimental programmes, including pilot plant operations and studies.
• Experience designing, executing and implementing analytical development programmes.
• Experience working as a resource for MSAT Analytical team on analytical development and product Life Cycle Management projects.

Responsibilities

• Specialist in critical process parameters and product quality attributes.
• Key team member for analytical development and analytical/product Life Cycle Management projects.
• Work closely with the Autonomous Production Units (APUs) in the business to support analytical LCM execution activities on a daily/weekly basis.
• Reports on assigned analytical projects' progress and looks for opportunities to improve site performance.
• Works closely with MSAT, Quality, Operations, Validation and Regulatory, as well as program leads on assigned projects.
• Involves some interaction with sister sites through various projects/product forums.
• Supports boosters for CI improvements in MSAT-Analytical and QC as required.

Skills

Analytical development

LCM processes

MSAT collaboration

Analytical transfer

GMP troubleshooting

Validation activities

Process parameter knowledge

Education

Biology or Chemistry degree (NFQ 7/8)

Job description

Sanofi in Waterford, Ireland is seeking an Analytical Scientist on a 23-month fixed-term contract. You will drive analytical development and Life Cycle Management projects, collaborating with MSAT, Quality, Operations, Validation and Regulatory to ensure robust processes and product quality attributes.

You will lead analytical transfer projects, support process parameter optimization, and provide technical troubleshooting in GMP environments, with hands-on development and collaborative