Summary of Role:

This Manager - Facility Support Services role will be responsible for implementation of the CPA and CPS support strategy for the CSLM Melbourne facility. This role will be responsible for three teams - the Clinical Protein Suite (CPS) Support Team, the Central Preparation Area (CPA) Wash Team and the CPA Solution Preparation Team.

The role will include solution scheduling, preparation and management (including preparation, storage, delivery, and management), equipment wash scheduling and management (including collection, wash, autoclaving, storage and delivery management), raw material management (including dangerous goods management), equipment kitting, documentation generation and on-going document management, deviation management for operations and administration activities for the support of the CPS and CPA facilities.

This role will require to provide strategic definition, management, and direction for assigned resources to effectively support facilities, systems, and infrastructure on the CSL Melbourne site relating to CPS and CPA support services.

This role will also include management of full time FTEs, contingent staff and labour hire staff to provide services to the CSL Melbourne facility.

Reporting Structure:

• This position directly reports to Associate Director, Building Operations & Services
• This position works closely with other Senior Managers within Pilot Scale Operations department
• This position will involve management of multiple contingent, CSL and labour hire staff

Responsibilities:

• Manage Facility Support Services team for CSL Melbourne, including labour hire staff. This includes support staff located in the CPA Wash, CPA Solution Preparation and CPS
• Review, update and implement core CPA and CPS support procedures and training requirements to ensure compliance and data integrity
• Lead the implementation of site procedures across CPA and CPS support activities based on global guidance
• Lead change controls and deviation investigations related to operations within the CPA Solution Preparation facility and CPS support functions to ensure timely completion of corrective and preventive actions
• Lead facility licencing coordination for OGTR and TGA. Including ensuring the facilities are always audit ready
• Monitor support processes using defined KPIs based on global guidance and optimise processes for on-going operations
• Maintain good working relationships with relevant regulatory industry bodies, suppliers and internal/external customers and provide expert information on facility support processes to auditors when required
• Develop the team to operate following CSL values, manage performance and collaborate to improve performance

• Ensure CSL health and safety procedures and business policies are followed including performing EHS Risk Assessments

Job Environment

• This position is located at the CSL Melbourne site. This role may also require some work to be completed at the CSL Parkville during site transition
• Some working hour flexibility with a requirement for periods of overtime/weekend work

Essential Qualifications/Experience:

• Postgraduate degree (preferably PhD, ME/Sc or equivalent degree) and/or experience in relevant discipline
• 8+ years relevant industry experience with BE/S,
• 6+ years relevant industry experience with ME/S, or
• 2+ years relevant industry experience with PhD
• Substantial experience in project work, excellent communication and analytical skills
• Proficient written, presentation and verbal communication skills (English language)

Essential Skills, Knowledge & Attributes:

• Strong employee management skills
• Excellent knowledge of GLP, GMP and ICH guidelines
• Excellent knowledge of change control and deviation management, including being skilled in technical writing
• Knowledge of stability trials, monitoring of critical utilities, environmental monitoring and analytical method validation
• Ability to define problems, collect data, establish facts, solve problems, make recommendations, and draw valid conclusions in a timely and accurate manner
• Ability to handle many projects simultaneously and integrate project planning efforts across functions
• Ability to understand "the big picture" and approach problem-solving in a proactive team manner
• Ability to manage competing priorities and agendas
• Excellent stakeholder focus and collaborative mindset, ability to inspire others and at all times exemplifying CSL employee brand and values
• Attentive communication skills, understanding your counterpart, strong ability to build up trustful and forward-thinking business relationships as well as keeping your stakeholders informed, using influencing & negotiation skills if appropriate
• Able to react well to change, feedback or activities in the workplace
• Flexible working hours (role may include some late night/international teleconferences)
• Patient focused

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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