Job: Manager, MS&T (Process Sciences), Seqirus, Holly Springs, NC
Come join a company that tackles fascinating problems and find solutions to complex challenges. Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state of the art manufacturing facility and a deep expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we’re 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.
The Manager, MS&T will provide leadership and direction to a team of scientists and engineers which are responsible for Technical Support of daily operations, inclusive of the relationship between the process, equipment, and automation in the facility. The incumbent will be a MS&T Manager at the Holly Springs Influenza Vaccine manufacturing facility, supporting both Bulk and Fill-Finish Operations. The MS&T function provides strategic scientific direction and support for the manufacturing organizations to achieve supply targets and maximize capacity.
Responsible for managing a team of process experts that provide technical expertise to the manufacturing teams, colleagues and/or customers.
Provide technical support for manufacturing processes using Six-sigma methodologies and other problem solving techniques.
Support or lead initiatives related to process issues, liaising with Manufacturing, QA, C&Q, and line management.
Responsible to provide technical expertise and guidance in resolving critical deviation investigations, robust CAPA and relevant follow-up; lead product process related investigations including complex complaints, OOT, OOS.
Partner with Manufacturing to ensure the execution of the production processes is in conformity with up-to-date, registered, filed manufacturing process, approved instructions, cGMP and Health Authority regulations.
Provide technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
Subject Matter Expert to support inspections and audits.
Support and execute continuous improvement actions and projects, e.g. to improve process capability, throughput time (TPT), minimize wastes of materials and reworks.
Investigate and resolve recurring process capability deviations and issues that emerge from data trending and annual batch monitoring.
Develop creative solutions to technical and organizational problems in order to keep projects on schedule.
Maintains a depth of knowledge on the relationship between the process, the equipment, and the automation in the facility.
Ensure that equipment works to its specification and capacity.
Process and equipment owners, providing fit-for-purpose risk assessments for technology transfers.
Troubleshoots and investigates equipment problems in the facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.
Collects and analyzes and reports data (i.e. KPI) that drives continuous improvement initiatives. Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
Input into the Annual Product Review compilation.
Maintain ownership & accountability of the Continued Process Validation program.
Develops and Drives team performance, objectives, direction & priorities.
Bachelor’s degree required. Degree in Engineering or Science discipline preferred.
Minimum 10 years’ related industry experience, or 8 years with an advanced degree.
Demonstrated knowledge of GMPs and FDA requirements.
Preferred experience in cell culture manufacturing technologies, purification, formulation, and/or aseptic processes
Demonstrated leadership skills in a cross-functional matrix environment