Process Scientist III/Principle

Job Purpose:

The position will be part of the Manufacturing Sciences & Technology, Process Sciences team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk Operations.  The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity.

This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that support Bulk Cell Culture, Fill-Finish, or Technology Transfer teams.   

• Technical Expert for multiple assigned unit operations and processes in Downstream Bulk Manufacturing operations.  Responsible for the reliability and robustness of assigned products and/or processes.
• Provides leadership, support and guidance to the Downstream Bulk Manufacturing Suite Team.
• Manages and maintains process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)
• Identifies and leads implementation of complex continuous improvement projects to improve yield, reliability, and process robustness.
• Leads the execution of process validations, annual monitoring batches, and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution.
• Leads complex product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
• Provides input to internal and regulatory audits as appropriate, serving as a lead SME during audits.
• Provides technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
• Ensures protocols are executed as intended and oversees execution of protocols.
• Uses scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
• Drives continuous improvement initiatives to proactively prevent process failures. Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
• Contributes to Annual Product Reviews and Product Quality Review for analysis and for contributing to process technology innovations.
• Process and equipment owners, providing fit-for-purpose risk assessments for technology transfers.
• Troubleshoots and investigates equipment and process issues within the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.

• Bachelor’s degree required. Degree in Engineering or Science discipline preferred.
• Minimum 5 years of related pharmaceutical/Biotech industry experience required.  7+ years of experience preferred.
• Experience with cell culture manufacturing preferred.Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, with direct experience supporting biannual or pre-approval inspections.
• A solid understanding of scientific principles and the ability to apply your knowledge.
• Advanced troubleshooting skills with ability to mentor others.
• Strong Process improvement experience, certification in Lean/Six Sigma 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.

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.