Senior Manager, Biochemistry & Molecular Analytics

The Opportunity

Reporting to the Director, Technical Development, Analytical Development, you will lead technical staff and serve as a subject matter expert responsible for oversight of Biochemistry Analytics. You will oversee the development, characterization, and qualification of analytical biochemistry methods for proteins and process residuals. You will work on the analyses of drug substance, drug products, process and product-related impurities and pre-clinical stability across Flucelvax (cell-culture based) vaccine project. You will provide scientific expertise for process and product development projects in technical development of vaccines for us. Your experience will support projects that improve future growth, process improvements and in-process characterization testing.

Process and Product Development

You will:

• Manage a team responsible for Analytical testing, assay optimization and development and qualification of development of pre-clinical stability material for drug substance and drug product for the cell cultured-based influenza vaccine program for us.
• Represent Technical Development on teams related to FCC vaccine program for us.
• Ensure analytical methods are developed, optimized, characterized and qualified to support process and product development using ELISA, Electrophoresis, Wet Chemistry assays, other biochemistry methods for us.
• Identify development and improvement opportunities, create a supportive business case, and support teams to achieve those opportunities.
• Use a data-driven approach to progress development deliverables.
• Work with our Separation Science, Mass Spectrometry and biophysical 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 for us.
• Present results at internal and external meetings for us.
• Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
• Provide technical advice on issues within own discipline for us.

People Management

You will:

• Manage Biochemistry & Molecular analytics team, responsible for assay development and testing of the drug substance, drug products 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 implement improvements.
• Maintain a state of compliance for team through regular review of training and implementing training curricula improvements.

Operations/Quality Support:

You will:

• the liaison to TD and Operations, and represents 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
• Create a supportive business case, and support teams to achieve those opportunities

• Postgraduate degree (preferably MSc or PhD) or experience in relevant discipline.
• 5+ years' relevant industry experience or equivalent experience.
• 10+ years with BS, 8+ years with MS, 6+ years with PhD, biopharmaceutical analytical development is ideal
• Experience scientific achievement in relevant Life Sciences discipline.
• Experience working in, multicultural and international teams.
• Biochemistry methodologies including ELISA, Gel electrophoresis, SRD, and multiple Wet chemistry methods required
• Up to 10% travel

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.