Scientist I, Process Development

The Opportunity:

The Scientist I will be responsible for the development and characterization of preparative separation methods for sa-mRNA and process residuals. The scope of work will include the design of drug substance manufacturing process, close collaboration with in vitro synthesis, formulation and drug product teams. You will be responsible for 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 downstream processing methods such as FPLC, TFF and other types of bioprocess filtration to support process and product development.

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

• Work closely with the IVT, formulation and DP groups within BPD (Biopharmaceutical Product 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 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.

• Complete individual training and maintain a state of compliance.

• Adhere to all safety requirements.

• Support communication/updates as required.

Your Skills and Experience:

• Bachelor’s Degree in biology, chemical engineering or related scientific field with min. 3-4 yrs. of laboratory experience. Master’s or PhD degree in bioprocess related discipline preferred.

• Requires in-depth conceptual and practical expertise in preparative separation methodologies including aqueous chromatography, and bioprocess filtration.

• Experience with nucleic acid process development is highly desired.

• Experience with process modelling and CFD is desired.

• Knowledge and experience with statistical methods

• Provides technical advice on issues within own discipline.

• Experience in biopharmaceutical development is desirable.

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

• 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

• Proactively owns and drives assigned tasks to completion.

• Ability to present solutions to complex and strategic issues.

• Evidence of commercial awareness in technical strategies

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.