Ms&t Lead

5 months ago

Tullamarine, Australia Seqirus Full time

**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

**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**

**This is a 2 year fixed term contract with a permanent opportunity available for existing CSL/Seqirus employees**

**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.

**Do work that matters at CSL**:

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