Associate Director, Scientist sa-mRNA, Pipeline - job 1 of 2

The Opportunity:

The Associate Director will be responsible for leading process development for sa-mRNA programs. The scope of work will include the design of sa-mRNA IVT, purification and LNP encapsulation for clinical manufacturing processes. You will be responsible for cross functional collaborations with the analytical, manufacturing and research teams are also expected. The successful candidate is 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:

This position will be responsible for activities in sa-mRNA development strategy and execution for multiple programs, future process design planning and team management. Successful candidate will design business and experimental processes to enable product research and development. Design and create integrated processes and activities to ensure planned outcome. Lead teams in development or program and project strategy. Drive initiatives to support fully integrated strategies. Design economical production methods and operate within current regulatory and compliance environments.

• Supervise IVT, downstream processing steps such as chromatography, TFF, encapsulation and normal bioprocess filtration to support process and product development.

• Lead the design, execution, optimization, comparison and characterization of sa-mRNA processing methodologies.

• 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.

• Manage a team of 5-8 FTEs.

• 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:

• Minimum of MS degree with 12+ yrs. of experience or a PhD with minimum of 10 years relevant industry experience and / or equivalent experience in an academic environment

• Requires in-depth conceptual and practical expertise in preparative sa-mRNA/LNP production methodologies as well as chromatography and bioprocess filtration.

• 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, decision quality, functional/technical skills, peer relationships, perseverance and problem solving.

• 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

• Excellent customer focus with demonstrated management of customer expectations.

Our Benefits

CSL 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 CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

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