Purpose
Responsible for providing leadership, support, management, guidance and supervision for the Biologics group to ensure that all day to day activities of operations run smoothly and seamlessly. Responsible for assuring that all performance metrics, workload deliverables are completed in alignment with the sites business model. Build and maintain collaborative relationships with other team members within the site and departments.
Responsible for supporting Cell Culture, Central Services and Purification areas.
Performs general to complex duties in assigned area within the Biologics Production facility.
Complies with safety requirements, current Good Manufacturing Practices, and Standard Operating Procedures.
Organize daily and weekly shift activities and direct junior personnel in execution of daily and weekly tasks.
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 or implements changes of both physical and written procedures.
- Proficient in core and related work processes.
- Implements improvements to work processes.
- Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical/pharmaceutical or similar environment.
Qualification and experience
- Bachelor of Science.
- 5+ years of relevant experience.
- 2+ year 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.
