Job Description

The Scientist will provide analytical support using HPLC/UPLC and CE for process development, process related investigation and clinical trial material (CTM) production within the global Biopharmaceutical Product Development. They will be responsible for sample testing, assay qualification and assay transfer to clinical QC. They will support product and process development, stability, release, and characterization of reference standard, toxicology and clinical trial material.

The Role:

• Perform qualitative and quantitative analysis of viral vaccine candidates and standards under limited supervision/guidance.
• Execute analytical HPLC/UPLC and CE assays following SOPs to support vaccine process and product development programs.
• Perform method qualifications and transfers.
• Work on the sa-mRNA program in the Separation Sciences Team, working closely with Biochemistry, Biophysics, Mass Spec and Molecular & Cellular Biology groups within BPD-Global Analytical Development.
• Provide support on reviewing documentation in electronic laboratory notebooks and reviewing data in LIMS for specific lab-based processes.
• Ensure all experimental procedures and documentation are compliant with the highest quality and regulatory standards.
• Partners with diverse team members from various functions, countries, and members at various levels in the organization.
• Author study protocols, characterization reports, and/or scientific manuscripts for external publication and patent application.
• Work as a core team member.
• Serve as interface between BPD and other functions. Represents BPD department in cross-functional forums to support manufacturing and Quality Control.
• Utilize 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.
• Generate a supportive business case and support cross-functional teams to deliver those opportunities.
• Complete individual training and maintain a state of compliance.
• Follow all safety requirements.
• Support communication/updates as required.

Skills and Experience:

• 2+ years with MS or 0+ years with PhD or equivalent experience with a bachelor\'s degree in a relevant technical discipline.
• Experience in biotech or pharmaceutical development in one or more of various disciplines including Biology, Biochemistry, Biomolecular Sciences, Chemistry, etc.
• Proficient in operating and maintaining HPLC or UPLC systems.
• Have in-depth conceptual and practical expertise in HPLC/UPLC, and CE.
• Experience with Empower software.
• Hands-on experience with RNA and LNP analysis is highly desired.
• Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving.
• Data collection and reporting with knowledge of GLP/GMP environments is preferred.
• Good verbal & written & presentation communication skills in a cross functional environment.
• Attention to detail is a must.
• Proactively owns and drives assigned tasks to completion.
• Ability to work within a matrixed team environment is necessary.

Our Benefits

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.

Please take the time to review our to see what\xe2\x80\x99s available to you as a CSL Seqirus employee.

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 .

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 at CSL Seqirus.

Do work that matters at CSL Seqirus!

Watch our \xe2\x80\x98On the Front Line\xe2\x80\x99 video to learn more about CSL Seqirus

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