Scientist II

Job Summary

The prospective Scientist II will be responsible for 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.  The individual will provide scientific expertise for process and product development projects in technical development of vaccines.

Major Responsibilities

• Develop, optimize, characterize and qualify of analytical methods such as HPLC, UPLC, and CE to support process and product development.
• Utilize multiple modes of detection including UV, fluorescence, ELSD, and CAD.
• Work closely with the Mass Spectrometry, Biochemistry, and Molecular/Cellular Biology groups within TD-Analytical, as well as provide technical expertise in support of analytical methods being executed within the process development groups
• Author study protocols, development and characterization reports, as well as 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
• Support the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for TD 
• Proactively identify development and improvement opportunities
• Functions effectively as core team member on multiple concurrent projects and leads small projects

Operations/Quality Support

• Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC
• Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing 
• Uses 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
• Generates a supportive business case, and supports cross-functional teams to deliver those opportunities

People Management

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

Minimum Requirements

• Postgraduate degree (preferably MSc or PhD) and / or experience in relevant discipline
• Minimum of 3 years relevant industry experience and / or equivalent experience in a relevant academic environment.
• Requires in-depth conceptual and practical expertise in analytical separation methodologies including HPLC, UPLC
• Experience with Empower
• Experience in biopharmaceutical analytical development
• Prior experience managing and/or mentoring junior associates

Preferred Requirements

• Master of Science degree with 8+ years’ experience or 4+ years with PhD
• Provides technical advice on issues within own discipline
• Effective delivery of objectives in a complex matrix environment
• Ability to deal with rapid change
• Effective verbal & written communication skills in a cross functional environment
• Attention to detail
• Proactively owns and drives assigned tasks to completion
• Ability to present solutions to complex and strategic issues
• Evidence of commercial awareness in technical strategies
• Excellent customer focus with demonstrated management of customer expectations
• Effective presentation skills

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.