Cassandra Smoult
Mernda,VIC
Summary
Accomplished Manufacturing Director at CSL Seqirus, I excel in strategic planning and team leadership, significantly enhancing operational efficiency and employee engagement. My leadership has consistently delivered products meeting stringent regulatory standards, achieving notable quality enhancements and productivity gains. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
17
17
years of professional experience
Work History
Manufacturing Director - PNS
CSL Seqirus
05.2020 - Current
- Developed team by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Cultivated positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
- Lead and manage operational staff to manufacture products that meet pharmaceutical regulatory requirements, ensuring compliance with GMP
- Develop and implement operational controls, metrics, and procedures to achieve productivity, quality, cost, delivery, safety, and colleague engagement goals.
- Oversee plant maintenance programs and capital expenditure submissions to support production targets and financial goals.
- Lead continuous improvement initiatives, driving year-on-year standard time reductions and quality improvements.
- Manage department cost base, ensuring delivery of production plans within financial targets, including creating cost models for projects reflecting ROI and financial impact.
- Facilitate cross-functional relationships with Finance, Procurement, HR, and other enabling functions to support manufacturing objectives.
- Represent manufacturing on cross-functional site committees such as Validation, Change Control, Quality Review, EHS, and Technical Review.
- Conduct Gemba walks to identify and resolve issues, promoting Right First Time and Lean manufacturing tools
- Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
- Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
- Proactively identified potential risks and implemented mitigation strategies to minimise negative impacts on projects or business operations.
Production Manager - Products of National Signific
Seqirus
10.2019 - 05.2020
- Resolved issues quickly to maintain productivity goals.
- Managed multiple projects concurrently, ensuring timely completion and meeting budget constraints.
- Increased overall productivity by identifying bottlenecks in production process and proposing effective solutions.
- Led process change initiatives and collaborated with production areas and maintenance departments on mechanical performance management.
- Established and reported on production KPIs, contributing to overall operational efficiency and goal achievement.
Introduction of SAP – Parkville Manufacturing
Seqirus
02.2016 - 10.2019
- Reviewed processing schedules and production orders concerning inventory requirements, staffing requirements, work procedures and duty assignments, considering budgetary limitations and time constraints.
- Applied lean principles to improve workflow and quality and reduce waste.
- Anticipated and addressed production problems, material shortages, equipment malfunctions, and unavoidable delays.
- Managed project activities with effective communication and leadership, introducing SAP to enhance operational efficiency.
- Led process change initiatives in collaboration with manufacturing leadership, aligning with company goals and compliance requirements.
Production Manager – Midstream Processing
Seqirus
09.2012 - 02.2016
- Resolved issues quickly to maintain productivity goals.
- Managed multiple projects concurrently, ensuring timely completion and meeting budget constraints.
- Increased overall productivity by identifying bottlenecks in production process and proposing effective solutions.
- Oversaw quality control efforts, maintaining strict adherence to industry standards and regulatory requirements while achieving high levels of customer satisfaction.
- Managed continuous improvement initiatives to drive gains in quality, flow, and output.
- Collaborated with cross-functional teams to ensure timely delivery of high-quality products according to customer requirements.
- Partnered with leadership on recruiting, hiring and coaching production personnel.
- Enhanced production efficiency by streamlining processes and implementing lean manufacturing techniques.
Production Support Manager
Seqirus
05.2010 - 09.2012
- Managed manufacturing investigations and participated in high-level investigations such as product contamination and processing failures.
- Facilitated root cause analysis investigations and risk assessments, hosting third-party audits and championing quality initiatives.
- Managed safety issues within manufacturing, ensuring safe working environment.
Production Support Team Leader - Packaging
CSL
02.2010 - 05.2010
- Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
- Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
- Conducted value stream mapping on production lines to identify and implement efficiency improvements.
Validation Consultant
PharmOut
07.2007 - 02.2010
- Led multidisciplinary teams through complex validation projects, ensuring timely completion while adhering to strict regulatory guidelines.
- Managed validation budgets effectively, ensuring resources were allocated appropriately for maximum impact on project outcomes.
- Collaborated with cross-functional teams to establish comprehensive validation strategies.
- Designed and implemented environmental monitoring programs and temperature-controlled distribution strategies.
- Assessed equipment for compliance/functionality and provided training, coaching, and mentoring to ensure regulatory compliance.
Education
Graduate Certificate in Business Administration -
RMIT University
Melbourne, VIC2021
Certificate in Biosecurity -
Box Hill Institute of TAFE
Melbourne, VIC2022
Executive Leadership Certificate -
Cornell University
2024
MBA -
Australian Institute of Management
Melbourne, VICSkills
- Strategic Planning
- Team Management
- People Management
- Operations Management
- Creativity and Innovation
- Budget Management
- Charismatic Leader
- Team Leadership
Timeline
Manufacturing Director - PNS
CSL Seqirus
05.2020 - Current
Production Manager - Products of National Signific
Seqirus
10.2019 - 05.2020
Introduction of SAP – Parkville Manufacturing
Seqirus
02.2016 - 10.2019
Production Manager – Midstream Processing
Seqirus
09.2012 - 02.2016
Production Support Manager
Seqirus
05.2010 - 09.2012
Production Support Team Leader - Packaging
CSL
02.2010 - 05.2010
Validation Consultant
PharmOut
07.2007 - 02.2010
Graduate Certificate in Business Administration -
RMIT University
Certificate in Biosecurity -
Box Hill Institute of TAFE
Executive Leadership Certificate -
Cornell University
MBA -
Australian Institute of Management
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