Do you want to work with 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 an advanced manufacturing facility and 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 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 Drug Substance team is responsible for providing expertise related to the product and process to ensure continuity in FCC drug substance 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. You will work onsite in the Holly Springs office and 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.
Responsibilities:
- Primary contact for operational product and process related issues within either the upstream (cell expansion), downstream (purification) or support (buffers, medias, solutions, small parts, and assemblies) manufacturing areas.
- Facilitate cross-functional team discussions providing recommendations for improvement projects and drive projects to completion.
- Provide technical leadership to the Bulk Manufacturing Operations team.
- 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).
- Develop and encourage an inspiring team environment within the company culture.
Qualifications:
- Bachelor's degree required. Degree in Engineering or Science discipline preferred. Level of role commensurate with related industry experience (pharmaceutical/biotech operations 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.
Benefits Include Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
#LI-Onsite
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.
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. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization 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
