Job Description
The Opportunity
As the MS&T Lead for Project Banksia, you will provide manufacturing process, product leadership and technical expertise for technology transfer of drug substance manufacturing and drug product formulation.
Join our Project Banksia team constructing our Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Melbourne, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia's public health needs such as snake and spider antivenoms.
The Role
Reporting to the Senior Manager, Manufacturing Sciences & Technologies Technical Transfer Lead, you will:
- Provide technology transfer leadership in our manufacturing processes
- Oversee technology transfer deliverables such as gap and risk assessments, process descriptions, comparability protocols and reports
- Lead and influence project documentation e.g. review/draft input for creation of Technical Requirements Specifications, User Requirements Specifications, Functional Specifications, Quality Risk Assessments, Technical Transfer docs, Validation protocols, Batch Process Sheets and Standard Operating Procedures for the manufacturing process. Ensure documentation is technically sound, current and compliant with current regulatory requirements.
- Define process / equipment / automation / manufacturing execution systems (MES) requirements for the manufacturing process
- Ensure that all manufacturing processes and environments are implemented and operational according to the principles of cGMP as needed by relevant regulatory agencies and standards
- Coordinate subject matter expertise regarding tech transfer, manufacturing process, equipment selection and utility requirements.
- Collaborate within MS&T globally to use company best practices, facilitate application of new technology and share insights
Your skills and experience
- Bachelor's Degree in Chemical/Mechanical/Systems Engineering, Science or equivalent
- Minimum 7+ years' experience in a manufacturing environment, preferably Pharmaceutical but Food and Beverage, Chemical Manufacture or similar batch processing also considered
- An understanding of cGxP requirements for facility and process design and their operation is important
- Project management and stakeholder engagement skills required
- Direct experience with regulated manufacturing and clean room environments would be an advantage
How to apply
Apply now to support CSL during our next phase of growth. Applications close on 14th November.
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About Us
Our Benefits
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 Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!