Purpose:
- Oversee downstream manufacturing processes including largescale chromatography viral inactivation and aseptic filling of bulk drug substances.
- 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 of daily and weekly tasks.
Major Responsibilities:
- Operates equipment including Media Preparation Buffer Preparation and Glass Wash/Autoclaves bioreactors inoculum transfers filtration and chromatography equipment.
- Performs the setup 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.
Qualifications :
- Bachelor of Science (or equivalent experience).
- 8 12 years of relevant experience.
- 2 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.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Work :
No
Employment Type :
Fulltime