Live opening · Posted 7 hours ago
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About the role
Description supplied by the original job listing.
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
Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
Min 5+ years of relevant work experience in Biologics / Pharmaceutical industry required. Experience should include 3+ years of area/stream specific experience.
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.
Highly skilled specialist and strong problem solver who independently tackles complex assignments with initiative, contributing to the development of innovative concepts and techniques
Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment
Good interpersonal and communication skills required
Excellent team player, with experience in shift work required
Demonstrated ability to multi-task and work in a fast-paced environment, takes full ownership of tasks assigned and acts with personal integrity
Experience leading a shift team will be an added advantage
Employment type
Full-time
Work arrangement
No
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