About the job
As part of the production team and under the direction of the DSP Manager, you will join the team responsible for the purification of recombinant proteins produced on a large scale under GMP conditions. The production coordinator plays a pivotal role in the operational management of activities, ensuring GMP compliance and driving continuous process improvements.
This is a daytime position (not subject to a 3x8 schedule). While there is no direct management, you will have cross-functional responsibilities with team leaders and support functions.
Main Responsibilities:
Operational Support and Oversight:
· Assist the DSP Manager in organizing, planning, and coordinating purification activities.
· Ensure operations comply with production schedules and GMP requirements.
Quality Support Management:
· Deviations & CAPA: manage or support (initiate deviations, lead Booster meetings, participate in assessments, handle deviations, implement and follow up on service CAPA).
· Change Control: initiate and vet CCPs, approve and track associated actions.
· Inspection Readiness: participate in audit preparations, track action plans, and manage the workshop's state of readiness.
EHS (Environment, Health, Safety):
· Actively participate in EHS inspections and implement corrective actions.
· Contribute to the site's safety culture and maintain a compliant and safe work environment.
Process Transfer and Technical Documentation Management:
· Participate in process transfer activities. Validate MBR and production recipes.
· Contribute to coordination between MSAT and production teams for integrating new processes.
Purification Operations Management:
· Oversee and monitor computerized recipes.
· Coordinate with support functions (Quality, Engineering, Logistics, Planning).
· Actively participate in operational preparations (monitor BOM/POP needs, define Level III planning template).
Post-Production and Continuous Improvement:
· Audit and review lot records post-production.
· Track corrections and improvement actions.
· Participate in and track specific projects within the department.
· Lead or contribute to continuous improvement projects focused on performance, quality, and safety.
Backup:
· Provide backup for the manager on operational topics in their absence.
· Support operational teams: technical and scientific assistance.
· Supervise and coordinate purification activities: installation, qualification, and equipment use, monitoring chromatography and filtration steps.

