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 Biomanufacturing Supervisors, who are passionate about their work and excited to contribute to our continued growth.
Purpose:
- Provides leadership and guidance to the stream specific Biologics group to manufacture clinical and bulk drug substance per safety, regulatory and operational requirements.
- Responsible for assuring that all performance metrics and workload deliverables are completed in alignment with the site’s business model
- Builds and maintains collaborative relationships with other team members within the site and departments
- Responsible for supporting Cell Culture, Purification or Central Services 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
- Organizes daily and weekly shift activities and directs shift personnel in execution of daily and weekly tasks
Major Responsibilities:
Operational and Technical
- Coordinates stream and cross-stream initiatives to achieve department objectives
- Provides expertise in stream-specific manufacturing related topics and audits
- Drives process troubleshooting effort for issues, proactively anticipates issues
- Assists with the implementation of changes and CAPAs
- Resolves project hurdles by effectively utilizing available information and technical expertise
- Initiates or implement changes relevant to manufacturing process
- Operation of Computerised Systems (e.g. Manufacturing Enterprise Systems (MES), Human
- Machine Interface (HMI)/ Programmable Logic Controller (PLC), etc.)
- Demonstrates ownership of stream-specific operation area, with basic understanding of operations and constraints of all streams:
- 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
- Ensures safe work environment in accordance with regulatory and global/local EHS policies
- Reinforces importance of safety during critical operations and ensures that Positive Interventions and recommendations are regularly highlighted and acted upon.
Quality
- Oversees the creation or revision of batch records or standard operating procedures and associated training material.
- Responsible for supervision of manufacturing of bulk drug substance within the scope of safety and compliance/ cGMP manner
- Drives performance to ensure execution is carried out flawlessly to ensure Human Error related events are prevented in the shift team
- Provides inputs for investigation – impact assessment and appropriate CAPA
- Responsible for overall plant upkeep during the shift and ensuring plant is always audit-ready
- Reviews records for completeness and accuracy
- Point of contact for audit
Schedule
- Oversees deliverables ahead, anticipates complexities and prevents potential plant disruption
- Ensures processes are running as per planned schedule with minimal delays.
People and Culture
- Recruits, retains, manages performance and develops manufacturing personnel
- Sets a positive team environment and amplifies the AbbVie Ways We Work behaviors