Manufacturing Science

3 days ago

Parkville, 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**

LI-Onsite

**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

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