The Opportunity:

CSL Seqirus' has the new state-of-the-art Influenza cell-culture (FCC) and Products of National Significance (PNS) manufacturing facilities in Tullamarine. This latest facility features best-in-class sustainability paired with innovative production capabilities to tackle global and region-specific public health needs. Expected to be operational in 2026, Tullamarine will be the Southern Hemisphere's premier cell culture influenza vaccine manufacturing and research facility.

We are looking for a passionate and experienced Manufacturing Science & Technology (MS&T) Lead Engineer to join our Global MS&T Tech transfer team at Tullamarine. You will provide technical and process expertise for the transfer of CSL Seqirus products through a global network of Contract Manufacturing Organizations (CMOs), Research and Development scale, and intercompany movements. Your leadership will ensure compliance with cGMPs, SOPs, and applicable guidelines, driving strategic improvements within sa-mRNA, Bulk Cell Culture, and/or Fill-Finish.

Your role will involve direct technical transfer oversight and support to the manufacturing organizations in Australia, North America, Europe, Japan, and future new CMO locations across the world. You will also provide front line support of production and process-specific issues, track and implement continuous improvements to improve quality, yield and efficiency.

Responsibilities

Reporting to the Senior Manager, Global MS&T Tech Transfer, you will

Lead the product transfer team, addressing technical and operational issues, and coordinating with teams to resolve and prevent recurrence.Draft and manage manufacturing documentation, ensuring compliance actions are addressed.Lead assigned projects, track metrics and project statuses, escalate urgent matters, and ensure cross-functional team engagement.Assist with investigations related to product and process issues during the transfer process.Complete source documents and regulatory sections for new and updated filings, and provide SME responses to market authority questions.Ensure protocol execution by providing Associate training and on-the-floor support, and support process validations and PPQ execution.

Experience

Bachelor's Degree in a related scientific/engineering field10+ years of related industry manufacturing experience, experience working in a pharmaceutical/biotech operation in a similar technical role would be beneficial.Experience with cGMP, OSHA, EPA, and clean room environments.Strong understanding of engineering, equipment, automation principles and mechanical aptitude.High level of business acumen and soft skills to build relationships with external vendors and staff.

Why Join Us?

At CSL Seqirus, we are dedicated to protecting people and communities from influenza and other serious diseases. Our collaborative, global, and dynamic environment fosters innovation and motivates to succeed. Join us and be part of a team that is shaping the future of public health. Applications close on 26th February 2025.

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Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

We want CSL Seqirus 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 Seqirus.

Do work that matters at CSL Seqirus!

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus