MS&T Scientist / Engineer II (Drug Substance)

The Opportunity

You will be a member of the Manufacturing Sciences & Technology (MS&T) Technical Services team at the Holly Springs Cell-based Influenza Vaccine manufacturing facility and will join a team of Scientists and Engineers focused on Drug Substance production in a commercial Bulk Manufacturing operation. The MS&T organization at Holly Springs provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. Specifically, the MS&T Technical Services team is responsible for providing expertise related to the product and process to ensure continuity in manufacture. As subject matter experts of the process, the team will utilize quality systems to lead critical process deviations in support of batch release and ensure detailed implementation of process improvements.  Members will report to the MS&T Drug Substance Tech Services Manager, but are encouraged to work within the larger MS&T organization to build process understanding and develop valuable competencies.

The Role

• Provide technical leadership to the Bulk Manufacturing Operations team.

• Primary contact for operational product and process related issues within either the upstream (cell expansion), downstream (purification) or support (buffers, medias, autoclave) manufacturing areas.

• Responsible for process characterization, continuous process verification, data monitoring, and performance metrics necessary to implement continuous improvement projects to improve yield, efficiency, process robustness, and product quality.

• Author and maintain process documents necessary for investigations, process design, technical studies, and implementation of new materials.

• Solve process-related issues within the manufacturing facility, coordinating with appropriate teams to resolve problems and prevent recurrence.

• Provide technical training within production to maximize process understanding and enhance knowledge-based decision-making.

• Provide ownership of supporting manufacturing process documentation (process descriptions, parameter risk assessments, specifications, and sampling plans).

• Facilitate cross-functional team discussions providing recommendations for improvement projects and drive projects to completion.

• Develop and encourage an inspiring team environment within the company culture.

Your skills and experience

Education & Skills

• Bachelor’s degree required. Degree in Engineering or Science discipline preferred.

• Displays understanding of basic engineering and/or scientific principles and the ability to apply them towards effective problem solving.

• Possesses strong technical writing skills.

• Applies excellent organizational, planning and time management habits.

• Demonstrates the ability to work effectively in both a team environment and as an individual contributor. 

Experience

• Level of role commensurate with related industry experience (pharmaceutical/biotech operations preferred).

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 organization 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! 

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.