Qc Microbiology Manager

IDT Australia Limited has a proud heritage of nearly 50 years borne out of the Victorian College of Pharmacy in Parkville, Melbourne, Australia as a true biotechnology organisation helping develop and scale up new and emerging medicines and technologies many of which are part of the mainstay in Australian healthcare today.

IDT is a publicly-listed Australian pharmaceutical developer and manufacturer, based in Boronia Victoria. Partnering with pharmaceutical leaders IDT specialises in the development and the commercial manufacture of high potency active pharmaceutical ingredients (API) and finished drug products for local and international markets. 

The role

Working on-site, the role of Microbiology Manager is to lead and support the Microbiology team activity to deliver on IDT’s commitments in line with the Operations and Quality Plan, customer commitments, project deliverables and financial objectives and budget. 

Extensive cross functional interactions with Quality and Operations, Validation and Tech Transfer, Supply Chain, Engineering, Finance and Business Development groups and other staff up to and including clients. 

Key responsibilities include:

• Is a key input into the IDT Planning process and works with Business, Operations and Quality Control to help set, measure and delivery to project lead times. 
• Works cross functionally with key peers to ensure necessary inputs, support services and alignment of activities are in place for Microbiology to achieve plan. 
• Participate in IDT Planning pertaining to the future projects and design.
• Ensures Microbiology activities are performed in accordance with the IDT Quality System and GMP principles. 
• Works proactively with the Microbiology Team and Quality to build a Quality Excellence approach toward zero unplanned defects / LIR’s / incidents through effective process design, improvements, training and understanding.   
• Coordinates and helps drive completion of key Quality processes for document updates and effective application of the Quality System. 
• Manage the Microbiology team to deliver testing, operational support and project activities in line with Project plan and client deliverables.
• Provide effective communication, recognition, information sharing and feedback to the team to ensure awareness of progress, performance, constraints, opportunities and areas for development.   

Skills and experience

Minimum requirement for this position is a Science or Engineering degree and professional experience.  

Frontline leadership skills or training or a business qualification will also be well regarded. 

• At least 5 – 10 years’ experience in an equivalent GMP accredited Microbiological processing environment with clinical, development or commercial manufacture facility.   
• Ideally a multi-product environment with small or larger molecules as well as Sterile Asceptic Biologics experience as well as other presentations such as solid, oral or liquid format in vial, bottling, etc. 
• Strong demonstrated microbiological and technical expertise to underpin testing and quality requirements. 
• Experience and sound understanding of regulatory requirements for GMP and GLP according to drug development or commercial manufacture stage of processing and application. 
• Team leadership and coordination to align and develop team members to achieve goals in accordance with organisation aims. Excellent communication, interpersonal and presentation skills.
• Commitment to continuous improvement, operations excellence and root cause analysis techniques to drive improvements and production efficacy. 
• Strong personal organisation and planning skills and ability to structure and coordinate work of team in order to deliver on team results and individual work commitments. 

Why Work for Us:

At IDT we value Ownership & Accountability, Trust & Integrity, Adaptability, Teamwork & Collaboration, Innovation & Problem Solving. 

We are an equal opportunity employer.  Diversity, inclusion, flexibility, ongoing development, and a supportive workplace culture are a big part of the way we work.

If you join IDT you are joining a small collaborative team that values excellence.

Applications

This role is subject to a national police record check and employment medical.

Applicants must be an Australian Citizen, Permanent Resident or hold a valid work permit or visa. Work eligibility will be checked as part of the recruitment process.