Senior Manager, Biochemistry

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 in Holly Springs, NC. With 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 Head of Analytical Development, you will provide leadership for a team of technical staff and serve as a subject matter expert responsible for oversight of Biochemistry Analytics and will oversee the development, characterization, and qualification of analytical biochemistry methods for drug substance, drug products, and process intermediates. The scope will include analyses of DS, DP, process and product-related impurities and pre-clinical stability across cell-based influenza vaccines. You will provide scientific expertise for process and product development projects in technical development of vaccines. Support projects to achieve future growth through process improvements and provide support for in-process characterization testing.

Process and Product Development:

• You will directly manage team responsible for Analytical testing and assay optimization/development/qualification of development and pre-clinical stability material for drug substance and drug product for the cell cultured-based influenza vaccine program.
• Represent TD on teams related to FCC vaccine program.
• Guide team performance & accountability that aligns with our core values & behaviors and our leadership capabilities.
• Ensure analytical methods such as Elisa, Electrophoresis, Wet Chemistry assays, other biochemistry methods are Developed, optimized, characterized and qualified to support process and product development.
• Identify development and improvement opportunities, generate a supportive business case, and support teams to deliver those opportunities.
• Use a data-driven approach to progress development deliverables.
• Work with the Separation Science, Mass Spectrometry and biophysical groups within TD-Analytical, and provide technical expertise to support analytical methods being accomplished 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

People Management:

• Direct supervisor for Biochemistry & Molecular analytics team, responsible for assay development and testing of the DS, DP and in-process material of influenza vaccine program.
• Provide ongoing performance feedback to direct reports.
• Provide scientific/technical guidance and mentorship to TD FCC Process team.
• Model a culture of safety, ensures team follows requirements, and implements improvements.
• Maintain a state of compliance for team through regular review of training and implementing training curricula improvements.

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

Other:

• Produce data summaries and present project progress for internal audiences and in other groups (TD Operations, R&D QA, QC).
• Complete all individual training and maintain a state of compliance.
• Follows all safety requirements.

• Postgraduate degree (PhD or MSc), or BS with experience in relevant discipline
• Minimum of 5 years' relevant industry experience and equivalent experience in a relevant academic environment; 10 years with B.S. / M.S. degree.
• Requires in-depth conceptual and practical expertise in biochemistry methodologies for proteins including ELISA, Gel electrophoresis (including 2-D gel), SRID, and Wet chemistry methods.
• Requires previous management experience to manage analytical development team
• Experience in biopharmaceutical analytical development is desirable
• Familiar with R&D compliant quality systems, experience with FDA, EMA, and other regulatory regulations desired
• Knowledge to present solutions to complex and strategic issues
• Delivery of goals in a matrix environment
• with demonstrated management of customer expectations

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

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.