The Opportunity

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 located in Holly Springs, NC. With the state-of-the-art manufacturing facility and an 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.

Reporting to the Sr. Manager, Separation Sciences, you will oversee the development, characterization, and qualification of analytical separation methods for proteins and process residuals. The scope will include analyses of DS, DP, process and product-related impurities, stability by-products, and raw materials across multiple projects. You will provide scientific expertise for process and product development projects in technical development of vaccines.

The Role

Development Work:

• Develop, characterize and qualify of analytical methods such as HPLC, UPLC, and CE to support process and product development.
• Use multiple modes of detection including UV, fluorescence, ELSD, and CAD.
• Work with the Mass Spectrometry, Biochemistry, and Molecular/Cellular Biology groups within TD-Analytical, and provide technical expertise to support analytical methods being implemented within the process development groups
• Author study protocols, development and characterization reports, and scientific manuscripts for external publication
• Use a data-driven approach to progress development deliverables
• Present results at internal and external meetings
• Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
• Help develop strategies, plans, processes and methods to ensure product and process development, and method and process transfers and improvements for TD
• Identify development and improvement opportunities
• Function as important team member on multiple concurrent projects and leads small projects

Operations/Quality Support:

• Be an interface between TD and Operations, and represent TD department in forums to support manufacturing and QC
• Use experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing
• Use scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work
• Produce a supportive business case, and support teams to deliver those opportunities

People Management:

• Provide guidance to junior team members, interns and act as a resource for colleagues with less experience

Other:

• Complete individual training and maintain a state of compliance
• Follow all safety requirements
• Support communication/updates

Your skills and experience

• Postgraduate degree (preferably MSc or PhD) and experience in relevant discipline.
• Minimum of 3 years' relevant industry experience or equivalent experience in a relevant academic environment with PhD; Additional experience required with M.S. degree.
• Requires in-depth conceptual and practical expertise in analytical separation methodologies including HPLC, UPLC, and CE
• Experience with Empower is advantageous
• Provide technical advice on issues within own discipline
• Experience in biopharmaceutical analytical development is advantageous
• Previous management experience is advantageous

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Our Benefits

CSL 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 at CSL Seqirus.

Do work that matters at CSL Seqirus!

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus