Thank you for considering a near future opportunity with our company! As we enter our next phase of expansion, we are keen to connect with exceptional Biotechnologists, particularly Senior and Shift Lead Biotechnologists, who are passionate about their work's purpose and excited to contribute toward continued growth.
Purpose:
- Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
- Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
- Supports and leads operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
- Stands in as Deputy for Manufacturing Supervisor in his/her absence.
Major Responsibilities:
Operations and Technical
- Plans and executes manufacturing operations using validated programs (such as LIMS, SAP, DeltaV, POMSnet, automated control systems, etc.)
- Completes manufacturing tasks efficiently
- Demonstrates high degree of initiative to resolve issues
- Makes recommendations for and implements new procedures
- Acts independently to determine methods and procedures on new assignments
- Drives projects and innovations to streamline processes and operation steps
- Drives the resolution of anomalous processing events timely
- Initiates Demand Work Order
- Demonstrates ownership of stream-specific operation area:
- Upstream: Inoculation, Cell Culture and Recovery
- Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling
- Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, sampling of raw materials.
Safety
- Ensured safe work environment in accordance with regulatory and global/local EHS policies
- Reinforces importance of safety during critical operations and ensure that Positive Interventions and recommendations are regularly highlighted and acted upon.
- Leads safety risks assessments or participates in process hazard analysis as an operations representative (PHA)
Quality
- Responsible for the completeness and accuracy of all records
- Ensures that all batch related document errors are resolved in a timely manner to avoid batch review and release delays
- Communicates all events/issues effectively with relevant stakeholders
- Drive performance to ensure execution is carried out flawlessly to ensure Human Error related events are prevented
- Responsible for overall plant upkeep during the shift and ensuring plant is always in audit ready mode
- Is involved in preparation for regulatory audits and inspections
- Initiates Quality Records (Non-conformance)
Schedule
- Assists supervisor in planning to ensure adequate resources are available to support manufacturing demands per production schedule.
- Assigns tasks within the shift team to biotechnologists
- Provides inputs to supervisor and manufacturing planner in events of unplanned downtimes
- Represents the shift in cross-functional meetings
People and Culture
- Sets a positive team environment and exemplifies the AbbVie Ways We Work behaviors
- Coaches and trains other biotechnologists (100% trainer competency)
- Assists in developing training materials