Reporting to the Manufacturing Associate Director in MFG suite 6 or 7, the Shift Lead will initially be responsible for supporting all operational readiness activities to ensure the facility design meets end user requirements. Upon successful commencement of commercial operations, the role will evolve to leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. The Shift lead will be responsible for the recruitment, development and retention of the team in order to consistenty deliver on the specific KPI’s and also to meet with the expectations of our customers.
Essential Duties and Responsibilities
Leadership & People Management
- You will be responsible for leading Upstream or Downstream bio-processes. This may involve overseeing cell culture, solution prep, purification and drug substance filling activities.Responsible for managing and leading a large team of Bioprocess Associates (BPA) on shift
- Manages shift activities with production needs, prioritizes tasks and assigns resources accordingly.
- Makes technical decisions and escalates issues promptly.
- Manages all training and team communications including assignment and prioritization of work activities.
- Delivery of objectives is a key element of the role and managing performance management and development of direct reports.
- The shift lead will lead all employee relation matters and ensure challenges and opportunities are addressed proactively and in a timely basis.
- Will play an important role in the execution of the business plans while ensuring cross functional collaboration and leadership execution.
- Responsible for schedule adherence metric on shift; drives performance to ensure throughput and changeover targets are met.
- Responsible for emergency procedures, safety systems, safety performance, communication and behaviours on the shift.
- Leads team safety audits and walk downs as required and advocates a strong safety ethos with all employees.
- Actively participates in HAZOPs and other risk assessments as required.
- Reports and leads the investigation of safety or environmental incidents on the shift and records, reports and resolves/escalates unsafe conditions or near misses that are observed.Acts as authoriser for the Permit to Work in manufacturing during normal day shifts and in all areas across site in the out of hours
Compliance & RFT
- Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required.
- Reports and investigates batch deviations or quality issues on the shift and escalate issues promptly.
- Oversees the review of completed documentation and is responsible for RFT on shift.
- Conducts any checks, inspections or audits necessary.
- Responsible for housekeeping and audit preparations in assigned areas.
- Manage training for their shift team and own the respective training plan.
- Write, review, revise and approve of area SOPs, Batch Records, Logbooks & Training Competencies
- Technical Transfer and Project Support
- Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
- Where necessary, assist in Facility and Equipment start up and Validation activities.
- Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)