Process Scientist III, MS&T (Downstream) at Seqirus in holly springs, North Carolina

Posted in Other 23 days ago.

Job Description:

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Purpose:

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

This position provides technical expertise related to the process, equipment, and business systems that support manufacture of monovalent influenza drug substance.

Major Accountabilities:

  • Perform real-time process monitoring using quality systems such as data historian (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 pandemic preparedness batches, and short-term improvement projects, liaising with all the relevant functions to ensure accurate execution.

  • Provide subject matter expertise for complex product and process related investigations and deviations including complaints, Out of Expectation, Out of Specification.

  • Provide input to internal and regulatory audits as appropriate.

  • Provide front line support to Manufacturing during qualification of new equipment or validation of new processes.

  • Develops, maintains, and analyzes departmental metrics and key performance indicators (KPIs).

  • Provide technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.

  • Ensure protocols are executed as intended and oversee execution of protocols.

  • Use 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.

  • Contribute to Continued Process Verification, Annual Product Reviews, and Product Quality Review for analysis and for contributing to process technology innovations.

  • Maintains depth and breadth of knowledge on the relationship between the process, the equipment, and the automation in the facility.

  • Provides fit-for-purpose risk assessments for technology transfers.

Minimum Qualifications:

  • Bachelor's degree required. Engineering or Science discipline preferred.

  • Minimum of 5 years of experience required in pharmaceutical/biotech operations working in a technical or statistical analysis role.

  • Strong experience and knowledge of statistical software 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 preferred.

  • Must have strong communication skills and attention to detail.

  • Must be flexible, able to multi-task in a fast-paced environment and operate well in a team setting.

  • Advanced troubleshooting and problem solving skills.

  • Excellent organizational, planning and time management skills.