Scientist II - Molecular Biology

Job Summary: The individual is responsible for utilizing scientific expertise to lead commercial support and development projects through TD into Operations and providing ongoing technical support to Operations and Quality. Responsible for projects that will drive future growth through process improvements. Uses scientific knowledge to ensure studies are well thought out and have clear, measurable benefits. Leads and drives elements of these activities as required. Major Accountabilities: Development Work:
• Leads 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
• Uses a data driven approach to progress development deliverables
• Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities
• Responsible for using scientific knowledge to support site / global projects Operations/Quality Support:
• Serves as primary interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC.
• Utilizes extensive knowledge and experience with biopharmaceutical processes (i.e. downstream purification, chromatography) to provide technical leadership for production of drug substance and drug product in a GMP environment, and analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing.
• Utilizes extensive knowledge and experience authoring and providing technical content for Biologics License Applications.
• Uses scientific and statistical knowledge to provide leadership for product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work. People Management:
• Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
• Demonstrated leadership abilities through project leadership and mentoring. Other:
• Completes individual training and maintains a state of compliance
• Adheres to all safety requirements
• Supports communication/updates as required

The Opportunity:

You will be responsible for the in vitro sa-mRNA synthesis, encapsulation and characterization methods. The scope of work will include the design of drug substance manufacturing process, close collaboration with purification and drug product development teams. Cross functional collaborations with the analytical, manufacturing and research teams are also expected. You will be expected to supervise and mentor junior scientists. You will provide scientific expertise for process and product development projects in technical development of vaccines.

The Role:

• Develop, optimize, and characterize IVT and LNP encapsulation methods to support process and product development.

• Utilize multiple modes of product detection and quantitation including UV, NIR.

• Work closely with DP groups within BPD-Process Development, as well Analytical, Manufacturing and R&D -Provide technical expertise in support of developed process 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 BPD

• Proactively identify development and improvement opportunities

• Functions effectively as core team member on multiple concurrent projects and leads small projects

• Serve as interface between platform and pipeline teams, BPD and Operations, and represents BPD department in cross-functional forums to support manufacturing and QC.

• Utilize knowledge and 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 compliance, deviation, OOE and OOS investigations that require development support.

• Generate a supportive business case, and support cross-functional teams to deliver those opportunities.

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

Skills & Experience Required:

• Postgraduate degree (preferably MSc or PhD)

• Minimum of 3 years relevant industry experience and / or equivalent experience in a relevant academic environment.

• Experience in project work and excellent communication and analytical skills

• Requires in-depth conceptual and practical expertise in IVT and LNP methodologies

• Experience with nucleic acid process development is highly desired

• Experience with process modelling and CFD is desired

• Provides technical advice on issues within own discipline

• Values ethics, integrity and trust, perseverance and problem solving

• Experience in biopharmaceutical development is desirable

• Prior experience managing and/or mentoring junior associates is preferred

• Values ethics, trust, perseverance and problem solving

• 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.