Purpose Statement
Provide leadership, support, and management, guidance and supervision for the Biologics group to ensure that all day to day activities of operations run smoothly and seamlessly as well as assuring that all performance metrics and workload deliverables are completed in alignment with the site business model.
Organize daily and weekly shift activities and direct junior personnel in execution of daily and weekly tasks and provide assistance and troubleshooting where needed, in compliance with safety requirements, current Good Manufacturing practices, and Standard Operating Procedures.
Leads functional initiatives to achieve functional goals while building and maintaining collaborative relationships with other team members within the site and departments.
Major Responsibilities:
· Operates equipment including Media Preparation, Buffer Preparation and Glass Wash/Autoclaves, bioreactors, inoculum transfers, filtration and chromatography equipment.
· Performs the set-up and sterilization of components and process equipment.
· Monitors and adjusts equipment operation.
· Coordinates process sampling and routine measurements.
· Ensures that data is recorded, activities logged, and processes monitored appropriately.
· Interfaces with automated production systems and controls.
· Reviews records for completeness and accuracy.
· Authors or revises standard operating procedures.
· Coordinates activities in the startup and validation of new equipment or new areas.
· Trains junior members as a qualified/certified trainer.
· Communicates all events/issues with appropriate individuals.
· Initiates changes of both physical and written procedures.
· Proficient in core and related work processes.
· Leads improvements to work processes.
· Acts as advisor to shift or cross-shift or stream Supervisor, becomes actively involved as required. Acts as mentor for less senior personnel.
Qualifications
· Bachelor Degree (with at least 5 years of experience)
· Diploma (with at least 8 years of experience)
· 3 – 5 years of supervisory experience in Biotechnology/Pharmaceutical Manufacturing area
· Strong working knowledge of Microsoft and other software packages (SAP, LIMS)
· Experience with cGMP documentation and record maintenance
· Strong problem solving and prioritization skills are required
· Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment
