Senior Scientist, Drug Product Development

The Opportunity

Do you want to find solutions to complex challenges in a process development environment? Seqirus has an exciting opportunity to join the growing team within Technical Development. With expertise in influenza science, our team works on the latest development of technologies in influenza vaccines. We continue to explore novel concepts for longer term transformational approaches to influenza protection. We operate as one integrated global research and development organization, drawing together expert staff from different countries to collaborate with us. Together, we're working to protect communities from seasonal influenza and global pandemic threats.

Reporting to the Head of Process and Product Development, you will provide scientific expertise for the design and planning of drug product development projects. Support drug product development from early phase to late phase through formulation and process improvements. You will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits.

Process and Product Development:

• Lead Flu Cell Culture (FCC) drug product development through life cycle management for important projects based in the FCC technology space including seasonal and pandemic products
• Provide technical subject matter expertise in the drug product development space including formulation, process development, fill/finish, and delivery device design and selection for vaccine drug products
• Author and provide input to technical documentation including study protocols, technical reports, product and process development plans, contract development and manufacturing proposals, and technical transfer plans
• Represent Technical Development (TD) on project team(s) to provide program oversight, and define detailed plans to tactically complete projects
• Help develop strategies, plans, processes, and methods to ensure drug product and process development and process transfers
• Use a data-driven approach for technical decision-making including risk assessment and mitigation
• Collaborate with Technical Development leadership to create technical strategy for development of new drug products and life cycle management of legacy products
• Provide technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations

People Management:

• Promote culture of safety, ensures team follows requirements, and implement improvements
• Maintain a state of compliance for team and self through regular review of training and implementing training curricula improvements
• Provide ongoing performance feedback, technical guidance, and mentorship to direct reports
• Provide project level leadership within TD and in project teams

• Be an interface between TD and Operations, and represent TD department in technical transfer forums to support manufacturing and QC
• Use experience of drug product and fill/finish processes to provide technical support for production of drug product in 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 TD support

Other:

• Promote safety compliance among colleagues in the laboratory
• Produce high quality technical presentations for TD team members and other technical teams (e.g. MS&T)

• Postgraduate degree (preferably MSc or PhD) or extensive experience in relevant discipline with B.S. degree.
• Minimum of 5 years relevant industry experience or equivalent experience in a relevant academic environment.
• Technical expertise in biologics drug product development, including formulation, stability, fill/finish, analytical characterization, and delivery device design and selection
• Experience with emulsion chemistry, nanoparticle and microparticle characterization is ideal
• Experience in exploratory data analysis and statistical techniques including design of experiments
• Experience writing content for technical documentation including product and process development reports, regulatory CMC license sections, and presentations
• Experience managing teams of individual technical contributors (i.e. scientists, engineers)

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.